ADDerall

Adderall for Attention Deficit Disorder

Adderall is a stimulant medication used in the treatment of attention deficit disorder in both children and adults.

Made from a combination of four amphetamine compounds, Adderall is useful because it covers a broad range of attention deficit disorder symptoms, and because it is a "one a day" dosing. A child with attention deficit disorder usually has to take only one dose of adderall per day to get through school and get his homework done.

ADDerall

Adderall is a "cocktail" drug, or a mixture of four drugs, all from the amphetamine family. As a result it has a broad spectrum of symptom coverage. It also tends to last for about six hours per dose, so it can cover the entire school day.

It can be less "harsh" than Ritalin. ADDerall might be worth talking to your doctor about as either the first or second medication to try.

ADDerall tablets come in 5, 10, 20, and 30 mg doses offering great flexibility to a physician in targeting the optimum dose for any patient. Even greater flexibility is offered because the tablets are double-scored so they can be accurately split into halves or quarters. This means that ADDerall can be administered in increments as low as 1.25 mg, or adjusted in 1.25 mg increments.

ADDerall begins to work more gradually than Ritalin, or Dexedrine, and the "drop-off" slope is also much more gradual, meaning that there is less of a "trough" time at the end of the dose.

Expectations and Drawbacks of Adderall

ADDerall can be expected to work very well for the "space cadet" ADHD kids. Stimulants (including caffeine) are great for "inattention" or "brain fog" symptoms. We would estimate that 70% of Attention Deficit Disorder - ADHD Inattentive Type kids would respond to Adderall very nicely. For them, Adderall is a very easy treatment intervention.

Hyperactive-Impulsive kids respond less well to the stimulants. Maybe 60-65% will benefit.

Kids with impulsivity or temper outbursts either do very well, or they do very poorly.

These kids may also need something like Extress for temper, or Clonadine for extreme outbursts. We recommend the Extress nutraceutical medicine first. We have seen Extress work very well in reducing temper outbursts. You can buy it at from VAXA International. The Clonadine is like a "sledgehammer," but use it if you need to.

For the best results using a natural homeopathic medicine see our Specific Treatment Strategies, and use "Attend".

The main drawbacks of Adderall that we have observed are loss of appetite (feed a protein shake twice a day to help keep weight up), some irritability or anger (as when you have had too much caffeine), possible short term growth inhibition (though long-term this may not be a problem). Remember, every medication has possible bad side effects, so always closely monitor your child when taking medications!

If there is a problem, don't give the next dose, and call your doctor right away.

Adderall Side Effects

All stimulants have side effects, and the side effects from Adderall can be serious.

Any amphetamine can be over used and result in drug addiction.

Because Adderall is made from amphetamine, it can cause your child's heart to race, elevate heart rate to dangerous levels, and raise blood pressure to dangerous levels.

Adderall side effects include overstimulation of the central nervous system, dizziness, difficulty sleeping, tremors, headaches, hyperactivity, and tics or Tourettes Syndrome.

A common Adderall side effect is a dry mouth, a bad taste in the mouth, diarrhea, constipation, upset stomach, and loss of appetite.

Children often lose weight when taking stimulants.

Stimulants may reduce growth rates in children.

Sexual dysfunction is a common problem in adults using stimulants.

How effective is stimulant medication when compared to alternative treatments for ADHD?
See here.

Read FDA WARNINGS on Adderall

Clearly stimulants like Adderall work. But Adderall can also have serious side effects.

Alternative medicines like ATTEND also work, but without the side effects. They only drawback to ATTEND is that it takes about 30 days to really do the job, while stimulants begin working right away.

ADHD Stimulant Medication and ER Visits

ADHD Stimulant Medication and ER Visits for Heart Problems in Children

Are the risks of heart problems greater in children who are prescribed stimulant medications for ADHD than for children who are not taking such medications? The University of Florida researched this question and published their results in the journal Pediatrics in December, 2007.

What they found was that the use of stimulant medication for ADHD in children and teenagers may be the cause for an increased number of emergency room visits, or visits to the doctor’s office, because of cardiac symptoms such as a racing heart or increased blood pressure. But the study also found that deaths, or serious heart complications, are rare.

The researchers looked at the records of over 50,000 children and teenagers who had ADHD, and were treated with stimulants such as Ritalin and other Methylphenidate compounds, Dexedrine, and Adderall. Then they compared the findings from this group to a database of over 2 million children and teenagers to see if there were any differences.

What they found was the children and teenagers treated with stimulants for ADHD were about 20 percent more likely to have to go to a doctor’s office or emergency room with cardiac symptoms than children and teens that were not taking stimulant medications. In other words, for every 100 children or teens who have to go to the ER or doctor's office for scary heart symptoms, there are 120 children or teens who take stimulant medication who have to go to the ER.

However, rates of death or admissions to a hospital were no different that the rates among those not being treated with stimulant medications.

ADHD Medication and FDA Warnings

There is an ongoing controversy within various committees in the FDA about whether stimulant medications should carry a “black box” warning label. In 2006 the FDA added the “black box” warning to the labels of ADHD medications warning of possible heart risks from the medications. The warnings on the label included possible sudden death in patients who have heart problems or heart defects, stroke and heart attack in adults, and increased heart rates and increased blood pressure.

The authors note that they do not know the long-term implications of increased heart rate and blood pressure in children and teens treated with stimulant medications. They also noted that about 25 percent of children and teens treated with stimulants were also prescribed either an antidepressant medication or an antipsychotic medication, which can also impact the heart and blood pressure.

Read more about the study from the University of Florida.

Ampakine CX717 Trials Rejected -Press Release

Editor: Background information from wikipedia on Ampakine:
Ampakines are a new class of modified benzamide compounds known to enhance attention span and alertness. Their action is theorized to be due to facilitation of transmission at cortical synapses that use glutamate as neurotransmitter. This in turn may promote plasticity at the synapse, which could translate into better cognitive performance. The ampakines take their name from the glutamatergic AMPA receptor, which they strongly interact with.

Unlike earlier stimulants (e.g. caffeine, methylphenidate (Ritalin®), and the amphetamines), ampakines do not seem to have unpleasant, long-lasting side effects such as sleeplessness. They are currently (2005) investigated as potential treatment for a range of conditions involving mental disability such as Alzheimer's disease, Parkinson's disease, schizophrenia or neurological disorders as Attention Deficit Hyperactivity Disorder (ADHD), among others. In a 2006 study they were shown to have an effect after they had left the body, continuing to enhance learning and memory. Some examples include: CX-516 (Ampalex), CX546, CX614 and CX717.

FDA’s Psychiatric Division has Rejected Cortex’s Request to Study CX717 in Phase IIb ADHD Study

— Company plans to focus on Alzheimer’s disease PET scan study and the treatment of acute respiratory depression with CX717 —

Irvine, CA (October 11, 2007) – Cortex Pharmaceuticals, Inc (AMEX:COR) was informed on Wednesday, October 10, 2007, that the Food and Drug Administration (FDA) would soon be sending it formal notice that the agency would not approve Cortex’s Investigational New Drug Application for a Phase IIb study of CX717 in attention deficit hyperactivity disorder, or ADHD. The denial is based on results of animal toxicology studies filed by Cortex. As a result, the company has requested that the Division of Psychiatry Products (DPP) of the FDA inactivate its IND Application for ADHD.

The company has chosen at this time to not formally withdraw the IND Application in order to evaluate the formal response from the FDA. It will weigh the potential for providing additional data if the potential exists for re-activating the IND at a later date. While the company will need some time to review the specifics of the FDA’s written concerns, at this time Cortex does not believe it likely that a resubmission will occur.

However, Cortex clearly intends to continue its plans to develop CX717 for the acute treatment of respiratory depression (RD) and continue its study of CX717 in its Alzheimer’s disease PET scan study. Cortex believes that the IND application previously filed with the Division of Neurology Products of the FDA for the treatment of Alzheimer’s disease will not be affected by the actions of the DPP.

Cortex believes that by developing an acute use for CX717, such as treatment of respiratory depression, the risks perceived to be associated with higher chronic doses required for ADHD can be mitigated. Additionally, the risk/benefit ratio for the treatment of patients with life-threatening respiratory depression is substantially different than for the treatment of ADHD. Also, Cortex’s preclinical data for improvement of memory and cognition in animals consistently shows that the dose level of CX717 is 5-10 fold less than that required in animal models of ADHD. Hence, either lower dosage levels for chronic administration and/or acute uses are possible options for the continued development of CX717.

Finally, Cortex is committed to continuing the development of other compounds such as CX701, which the company believes will go into Phase I clinical trials shortly, and other low and high impact Ampakine® compounds which are currently in the preclinical pipeline. While this decision by the FDA represents a significant setback for the company, Cortex has a broad-based technology platform that is currently producing several other significant future clinical candidates.

Cortex Pharmaceuticals, Inc.
Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for neurological and psychiatric disorders. Cortex is pioneering a class of proprietary pharmaceuticals called Ampakine compounds, which act to increase the strength of signals at connections between brain cells. The loss of these connections is thought to be responsible for memory and behavior problems in Alzheimer’s disease. Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brain's neurotransmitter system. These imbalances may be improved by using the Ampakine technology. Cortex has an alliance with N.V. Organon for the treatment of schizophrenia and depression. In December 2006, Cortex terminated the research collaboration with Servier enabling Cortex to pursue the use of Ampakine compounds in the treatment of neurodegenerative diseases on a global basis. Servier retained the right to select up to three compounds developed during the collaboration for further development for the treatment of neurodegenerative diseases. Cortex may receive additional milestones and royalties if either Organon or Servier is successful in developing and commercializing Ampakine compounds. For additional information regarding Cortex, please visit Cortex Pharmaceuticals’ Website at www.cortexpharm.com.

Forward-Looking Statement
Note – This press release contains forward-looking statements concerning the Company’s research and development activities. The success of such activities depends on a number of factors, including the risks that the Company’s proposed compounds may at any time be found to unsuitable for moving into clinical studies or be unsafe or ineffective for the indications under clinical test and that pre-clinical and clinical studies may at any point be suspended or take substantially longer than anticipated to complete. As discussed in the Company’s Securities and Exchange Commission filings, the Company’s proposed products will require additional research, lengthy and costly clinical testing and regulatory approval. Ampakine compounds are investigational drugs and have not been approved for the treatment of any disease.

CDC Reports that Cough and Cold Medicines Send 7,000 Children to Hospital Each Year

The Associated Press is reporting that the Center for Disease Control (CDC) is estimating that each year cough and cold medicines send about 7,091 children to hospital emergency rooms.

Of these 7,000 cases, about two-thirds of the cases were children who took the medicines unsupervised. Of the remaining 2,600 cases, about 1,600 were were children under the age of 2 years old who were given over-the-counter cough and cold medicines that the FDA considers to be too dangerous for such young children.

However, about one-quarter involved cases in which parents gave the proper dosage and an allergic reaction or some other problem developed, the study by the U.S. Centers for Disease Control and Prevention reported.

CDC researchers gathered case reports of children 11 and under who had taken cough and cold medications and wound up in 63 hospitals studied in 2004 and 2005. They used that number to come up with the national estimate.

"The main message is no medication left in the hands of a 3-year-old is safe," said the CDC's Dr. Melissa Schaefer.

Many of the ER case reports were not specific about symptoms, and the researchers did not follow cases through to conclusion. So they did not know if — or how many — deaths resulted, said Schaefer, an epidemiologist who was the study's lead author. For the children whose symptoms were reported, allergic reactions like hives and itching were most common, and neurological symptoms like drowsiness and unresponsiveness were next, she said. Most of the medicines involved were liquid combinations of cough and cold treatments, CDC researchers said.

The study was published online Monday. It will appear in the April issue of Pediatrics, a journal of the American Academy of Pediatrics.

Daytrana

What is DAYTRANA?

Is the "Daytrana patch" a Good Choice for You?

Last summer Shire Pharmaceuticals came out with their new version of methylphenidate, called DAYTRANA. It is the first and only patch, or transdermal medication approved to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD).

DAYTRANA is methylphenidate (generic name for Ritalin) in a patch, which makes it a very convenient delivery system (one a day dosing).

The response from parents has been mixed.

Parents, and patients, like the convenience of a patch. And they also like the fact that children don’t have to swallow a pill.

But the patch can cause side-effects. Skin rashes, sleeplessness, stomach aches and motion sickness are commonly cited. Some parents also complain that they have to fight with their kids to put the patches on, and it leaves a “goo” after taken off.

You can learn more about DAYTRANA at its website.

As always, parents should know that DAYTRANA is a Schedule II controlled substance.

Daytrana Side Effects

It was generally well tolerated in clinical studies, but some subjects had side effects. As with other products containing methylphenidate the common side effects reported in children who received DAYTRANA were

• decreased appetite,
• insomnia,
• nausea,
• vomiting,
• weight loss,
• tics,
• affect lability (mood swings).

It is the same list of side effects one would see with Ritalin in any of its forms.

The manufacturer warns that Methylphenidate should never be taken by children with:

• significant anxiety,
• agitation,
• extreme temper outbursts,
• glaucoma,
• tics or Tourette's syndrome, or family history of Tourette's syndrome,
• current/recent use of MAO inhibitors (a type of antidepressant),
• problems with alcohol or drugs,
• has had depression,
• abnormal thoughts/behaviors,
• visual disturbances,
• seizures,
• high blood pressure,
• heart conditions including structural abnormalities.

The manufacturer warns that abuse of methylphenidate may lead to dependence.

As always, tell your doctor immediately if any of these unlikely but serious side effects occur: blurred vision, uncontrolled movements (twitching, shaking), uncontrollable outbursts of words or sounds (e.g., Tourette's syndrome), unexplained weight loss, mental/mood/behavior changes (e.g., agitation, aggression, mood swings, depression, abnormal thoughts, hallucinations).

Daytrana Drug Interactions

Your doctor or pharmacist should already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine) within 2 weeks before or after treatment with this medication.

In some cases, a possibly fatal drug interaction may occur.

If you are currently using any of these medications, tell your doctor or pharmacist before starting this medication. Or better yet, just don’t use this medication.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription herbal products you may use, especially of: "blood thinners" (e.g., warfarin), clonidine, guanethidine, drugs that can increase blood pressure (e.g., epinephrine, phenylephrine), anti-seizure drugs (e.g., phenobarbital, phenytoin, primidone), tricyclic antidepressants (e.g., imipramine, desipramine), SSRI antidepressants (e.g., fluoxetine, sertraline), other stimulant medications (e.g., amphetamines).

Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with methylphenidate such as bupropion, isoniazid (INH), phenothiazines (e.g., thioridazine), or theophylline, among others. Consult your doctor or pharmacist for details.

Check the labels on all your medicines/herbal products (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure (e.g., pseudoephedrine, phenylephrine, ephedra/ma huang). Ask your pharmacist about the safe use of these products.

Daytrana: Our Thoughts

We are not opposed to Daytrana, or Ritalin, or Methylphenidate in any of its forms, provided that the “alternative” options have been tried, and have failed.

We are referring to ADHD diet interventions, Attend and other amino acids such as Extress or Memorin, essential fatty acids (omega oils), and perhaps EEG Biofeedback training.

DAYTRANA Risks

Is methylphenidate over-prescribed? Is it over-used?

Probably. But the reason why Ritalin is used so much is that it works. Think about it. No one would use it if it didn’t make a positive improvement in the life of their child.

But Ritalin, DAYTRANA, and all the other forms of methylphenidate (in fact, all the other forms of prescription treatments for ADHD) come with the problem of potential side effects. And some of these side effects are severe.

So, please try our recommended ADHD eating program plus the specific Attend treatment strategies first. Consider EEG Biofeedback training if you can afford it.

Try these “alternatives” first if you can and see if they work. If they do not work for you or your child, then by all means carefully consider the use of prescription stimulants.

See our comparison of the effectiveness of your treatment options.

A Parent's Comment on Daytrana

This comment was posted on our ADHD Newsletter website by a parent in February, 2007 following the posting of the above article on Daytrana.

"This patch has been a god send for us!!! If our child washes the glue off and moisturizes the skin area there are very few problems other than decreased appetite."

Parents, share your experiences with Daytrana below.

Dexedrine

Dexedrine (Dexamphetamine or Dextroamphetamine)

Dexedrine is a central nervous system stimulant used in the treatment of ADHD.

It is from the amphetamine family, and is manufactured in 5mg, 10mg, and 20mg pills, and 5mg, 10mg. or 15mg capsules. Dexedrine comes in a very effective Spansule formula for a longer effective dose (one dose a day gets you through school).





It is very similar to Ritalin in its benefits to individuals with ADHD. It can be less harsh, as it seems to start more gradually, and come to the end of its dose without the harsh "crash" or "trough period" of Ritalin.

Here is an alternative to Dexedrine to consider. In the chart below compare the effectiveness of Stimulant medication (most of the subjects were using Ritalin, but many were using Dexedrine or Adderall in the study, and all were lumped together into the category of "stimulants") with ATTEND natural homeopathic medicine with specific amino acid combinations. You will find that the ATTEND is as powerful as the stimulants, but is much easier to tolerate, has fewer side effects than Dexedrine or other stimulants, and is much healthier.

Dexedrine Side Effects

Even though Dexedrine can be helpful in the treatment of ADHD, the list of drawbacks, or Dexedrine side effects, is very long.

Read the list below, and then consider ATTEND the alternative to Dexedrine.

FDA Warnings on Dexedrine

Do not take monoamine oxidase inhibitors with this drug. Check with your physician if you are taking any of the following: Chlorpromazine, ethosuximide, haloperidol, antihypertensive, medications, meperidine, norepinphrine, phenytion, propoxphene, any beta blocker, digitalis, or thyroid hormones. A variety of neurological toxic effects can occur, sometimes with fatal results.

AMPHETAMINES HAVE HIGH POTENTIAL FOR ABUSE. USE OF AMPHETAMINES FOR A PROLONGED PERIOD OF TIME MAY LEAD TO DRUG DEPENDENCE.

The habit-forming potential is high. Psychological and physical dependence is possible. Addiction is rare in children but a problem with adults.

Long-term effects on children have not been well established (might be a problem). Children who take this drug on a long-term basis should be examined every four to six months.

The physician should:

• monitor height and weight to see if growth is being inhibited as feared might happen,
• check for the presence of tics which may start after using stimulants,
• measure blood pressure and pulse which may elevate unacceptably with stimulant use,
• and ask about other Dexedrine side effects.

Do not take this drug if you are pregnant or if planning to become pregnant. Do not take if you are breast-feeding.

Do not give this drug to children under the age of three.

Do not drink alcohol while taking this drug.

Do not use if: You had negative reactions to this or any other amphetamine in the past. If you have a history of drug alcohol abuse. If you have a psychotic disorder of any type.

Inform your Doctor if:

• You had negative reactions to this or any other amphetamine in the past.
• If you have epilepsy, glaucoma, heart / blood vessel disease.
• If you have high blood pressure, or a history of Touette's syndrome.
• If you are taking any other prescription or nonprescription drug.
• If you will have anesthesia or any surgery in the next few months.
• If you will be undergoing any medical tests.
• If you have a history of drug or alcohol dependence.

Dextroamphetamine ( Symptoms or Effects )

Pretty Common Dexedrine Side Effects include : Nausea, diarrhea, loss of appetite and weight loss, difficulty sleeping, restlessness, and anger.

Less Common, but Serious Dexedrine Side Effects include : Abdominal pain, headache, loss of appetite and weight loss, mood changes, increased temper outbursts, lack of coordination, tics or other unusual movements, Tourette's Syndrome, irritability, dizziness, difficulty sleeping, nervousness, skin rash, hives, blurred vision, sexual problems, or paranoia. If any of these start, SEE YOUR PHYSICIAN ASAP.

Beware of: Nausea, diarrhea, loss of appetite, difficulty sleeping, drowsiness, dizziness, or restlessness. SEE YOUR PHYSICIAN ASAP.

Stop taking the Dexedrine, and see your physician NOW: Abdominal pain, headache, lack of coordination, tics / unusual movements, skin rash, hives, or paranoia.

Why Not Try ATTEND first?

ATTEND is a powerul, safe, and healthy alternative to Dexedrine without the potential Dexedrine side effects.

Keywords: Dexedrine Side Effects and an Alternative to Dexedrine

FDA Black Box Warning Labels on ADHD Medications

After much debate the following medications carry the "black box warnings" on the labels of the bottles. These are the strongest warnings that the FDA requires, a step away from pulling the medications.

• Adderall Tablets (mixed salts of a single entity amphetamine product)
• Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
• Concerta (methylphenidate hydrochloride) Extended-Release Tablets
• Daytrana (methylphenidate) Transdermal System
• Desoxyn (methamphetamine hydrochloride) Tablets Label (will be updated soon)
• Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
• Focalin (dexmethylphenidate hydrochloride) Tablets
• Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
• Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
• Methylin (methylphenidate hydrochloride) Oral Solution
• Methylin (methylphenidate hydrochloride) Chewable Tablets
• Ritalin (methylphenidate hydrochloride) Tablets
• Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
• Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
• Strattera (atomoxetine hydrochloride) Capsules

Warnings for Amphetamine, Dextroamphetamine, Lisdexamfetamine dismesylate, Methamphetamine, Mixed Salts of a Single Entity Amphetamine Products

Adderall, Adderall XR, Desoxyn, and Dexedrine (SR)

• High abuse/diversion potential: Amphetamines have a high potential for abuse. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly.
• Drug dependence: Administration of amphetmaines for prolonged periods of time may lead to drug dependence and must be avoided.
• Serious Adverse Events: Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events

Warnings for Dexmethylphenidate, and Methylphenidate Medications

Ritalin, Ritalin LA, Ritalin SR, Concerta, Daytrana, Desoxyn, Focalin, Metadate, Methylin

All Dexmethylphenidate, Methylphenidate Products

• Chronic abusive use can lead to a marked tolerance and psychological dependence with varying degree of abnormal behavior
• Frank psychotic episodes can occur, especially with parenteral abuse.

Methylphenidate Products: Concerta, Metadate, Ritalin, Daytrana
Dexmethylphenidate Products: Focalin

• Should be given cautiously to patients with a history of drug dependence or alcoholism.
• Careful supervision required during drug withdrawal from abusive use since severe depression may occur.
• Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Methylphenidate Products: Methylin Products

• Should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative.
• Careful supervision required during drug withdrawal, since severe depression as well as the effects of chronic over-activity can be unmasked.
• Long term follow-up may be required because of the patient's basic personality disturbances.











Strattera Atomoxetine

Strattera Suicidal Ideation in Children and Adults



• Atomoxetine increased the risk of suicidal ideation in short-term studies in children or adolescents with attention-deficit/hyperactivity disorder (ADHD).
• Anyone considering the use of atomoxetine in a child or adolescent must balance this risk with the clinical need.
• Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior.
• Families and caregivers should be advised of the need for close observation and communication with the prescriber.

Largest Study Ever of Heart Risks with ADHD Medications

AHRQ and FDA To Collaborate in Largest Study Ever of Possible Heart Risks with ADHD Medications

Press Release Date: September 17, 2007

Two U.S. Department of Health and Human Services agencies will collaborate in the most comprehensive study to date of prescription medications used to treat attention deficit hyperactivity disorder (ADHD) and the potential for increased risk of heart attack, stroke or other cardiovascular problems.

Researchers supported by the Agency for Healthcare Research and Quality (AHRQ) and the U.S. Food and Drug Administration (FDA) will examine the clinical data of about 500,000 children and adults who have taken medications used to treat ADHD to determine whether those drugs increase cardiovascular risks.

Because medications used to treat ADHD can increase heart rate and blood pressure, there are concerns about the drugs' potential to increase cardiac risks. It is also thought these risks may be different for adults and children, but more evidence is needed about the long-term effects of using ADHD medications.

The planned analysis follows an FDA-sponsored preliminary study that compiled information from large health care databases on prescription drug use, inpatient care, outpatient treatment, and health outcomes, including death. Based on that effort, researchers identified people who took ADHD drugs during a 7-year period ending in 2005. AHRQ, which sponsors research on clinical effectiveness and safety, will team with FDA to complete the analysis of the data.

"This study highlights one of AHRQ's most important missions: to collect and analyze scientific evidence that will help patients, policymakers, and clinicians make the best possible decisions," said AHRQ Director Carolyn M. Clancy, M.D. "This partnership with the FDA is a great way to move closer to answering important clinical questions that affect children and adults who have ADHD."

"Case reports have described adverse cardiovascular events in adult and pediatric patients with certain underlying risk factors who receive drug treatment for ADHD, but it is unknown whether or not these events are causally related to treatment," said Gerald Dal Pan, M.D., director of FDA's Office of Surveillance and Epidemiology. "The goal of this study is to develop better information on this question."

The study will be coordinated by Vanderbilt University researchers on contract through AHRQ's Effective Health Care program. Data analysis will be performed by researchers at Vanderbilt, Kaiser Permanente of California, the HMO Research Network and i3 Drug Safety, as well as from FDA and AHRQ. The analysis will include all drugs currently marketed for treating ADHD. The study will analyze the risks of all the drugs as a whole, and risks of the drugs grouped by class.

The analysis will take about 2 two years to complete. Results are expected to be important not only to patients, their families and health care providers, but also to government insurance programs. Medicaid, Medicare, and the State Children's Health Insurance Program provide reimbursement for drugs prescribed for ADHD. This information could also be used to inform product labeling, which is used by health care providers when making treatment decisions.

ADHD is a behavioral disorder that, in many patients, causes hyperactivity, and may have a significant impact on school performance and social functioning. According to the National Institute of Mental Health, ADHD affects approximately 3 percent to 5 percent of school-age children and about 4 percent of adults.

Use of ADHD drugs has increased in recent years among children and adults. A recent AHRQ analysis of medication expenditures found three ADHD drugs—Concerta, Strattera, and Adderall—ranked among the top five drugs prescribed for children ages 17 years and younger. About $1.3 billion was spent on those drugs in 2004, the study estimated. Adult use is also believed to be increasing.

In May 2006, based on a review of anecdotal reports of heart attack, stroke and sudden death among patients taking usual doses of ADHD medications, the FDA asked drug manufacturers to revise product labeling to reflect concerns about possible adverse events. Drug manufacturers have created patient Medication Guides for individual products to help patients understand risks.

FDA and AHRQ recommend that individuals using or being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current health status, particularly for cardiovascular and psychiatric problems, including assessment for a family history of such problems.

Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/press/pr2007/adhdmedpr.htm

Parents Caught in the Middle as FDA Committee Debates

FDA Hearings on Ritalin: Black Box Labeling Recommendation for ADHD Medications in Debate

On February 9, 2006, the FDA’s standing Drug Safety and Risk Management Advisory Committee was tasked for the morning to study ADHD medications to see if there was a link between the stimulant medications and an increased risk of sudden death or serious cardiovascular problems from taking the medications.

The FDA also tasked the Committed with considering ways of studying the drugs without putting patients at risk.

This FDA advisory committee is a standing committee that studies all types of medications and products. Members of the committee have a broad range of experiences and education, and report on a range of agenda items through the year. The information below comes from sources ranging from news reports to the FDA Advisory Committee’s own website.

As the committee considered ADHD medications, after some discussion, the Committee took action and voted 15-0 to recommend that the FDA require a “medication guide” for parents and patients to read for all prescriptions of ADHD medications. Good thinking and common sense applied.

However, some members of the Committee got off task immediately and began to debate the link between the medications and 25 reported deaths of patients who had been taking ADHD medications over a four-year period of time (1999-2003). Many of these patients had pre-existing heart problems.

The FDA’s Dr. Kate Gelperin, who is a medical officer in the Office of Drug Safety, joined the conversation and reported to the Committee that an analysis of the reports of death and injury suggest a possible link between the drugs and cardiovascular problems, but that it is not “conclusive” that a link exists, it is just a possible link. Nor is it clear that there is actually an increased incidence of death or serious injury from taking ADHD medications. “This is really a question that we would like to have answered,” said Dr. Gelperin, referring to the Committee’s reason for existence.

An previous FDA review found less than one death, or serious injury, per 1 million prescriptions filled for ADHD medications.

Some members of the Committee then changed the subject, stopped talking about safety, and charged that ADHD medications are seriously “over-prescribed.”

Cardiologist Steve Nissen, a consultant to the Committee, stated that there was an out of control growth in the rate of ADHD medications being prescribed to adults, and stated, “We have to elevate the level of concern” about the “out-of-control use of drugs that [may] have profound cardiac effects.”

Dr. Nissen pushed for a “black box” warning label on all ADHD medications. Over-prescription, rather than safety, now became the issue under debate. The “black box warning,” normally a response to a safety issue, would now be recommended to slow the rate of growth in prescriptions.

The committee never considered the possibility that the reason for the increase in the use of ADHD medications is that they actually work, and that people might refill their prescriptions for the medications because they may actually improve the quality of their lives.

After debate, the Committee voted 8-7 to recommend the most serious type of warning, a “black box” warning label, for ADHD medications because of “potential cardiac risks” (not mentioning that they were really more concerned about the rate of growth in the use of the medications).

March 23, 2006. Following the actions of the Drug Safety and Risk Management Advisory Committee, the FDA had asked their Pediatric Advisory Committee to also study the issue, and they met to make their recommendations.

The Pediatric Advisory Committee rejected the recommendation from the Drug Safety and Risk Management Advisory Committee that medications used to treat ADHD should have the strongest type of warning, called a “black box” warning. The Pediatric advisory committee did recommend adding more information to the labels of these medications for doctors, patients, and parents.

The FDA must now consider the recommendations of both advisory committees and determine what, if any, action to take regarding ADHD medications. No one knows for certain how many children and teens are prescribed these medications for ADHD, but estimates range from 2 million to 3.3 million in the United States alone.

It is important to understand that all stimulants have potential side-effects, including loss of appetite, increased heart rate, and less commonly a risk of seizure, heart attacks, hallucinations, and more. People with heart conditions should not take or use any stimulants, from caffeine (Starbucks coffee, Mountain Dew, Diet Pepsi, or even chocolate) to medications.

The medications can be controversial. For example, Health Canada had pulled Adderall from the market in Canada last year, but then found that there really was very little evidence linking the medication to these serious problems. Adderall was returned to the market after a few months. The Health Canada report can be read online.

Strattera already has a “black box” warning in the U.S. that it may cause suicidal thoughts in children. It also carries a similar warning in Canada.

About the debate, it is important to understand that the Drug Safety and Risk Management Advisory Committee is composed largely of Risk Management specialists. None of the members treat children or teens for ADHD, and only know of the issue second hand. According to the FDA Advisory Committee web site the Committee is composed of 2 Internal Medicine MDs, 1 Ambulatory Care and Prevention MD, 6 PhD’s or equivalent in Pharmacy or Pharmaceuticals, 1 Lawyer, 1 Pharmaceutical Industry Representative, 0 Pediatricians, 0 Psychiatrists, and 0 Family Practice Docs.

After the Drug Safety and Risk Management Advisory Committee voted 8-7 for the “black box” warning on ADHD drugs, the FDA asked the Pediatric Advisory Committee to examine the same issues. This committee was composed largely of Pediatricians and Child Psychologists who actually treat children for a living, and often prescribe medications for ADHD patients. A list of the members of this Committee can be found at the advisory committee website.

The Pediatric Advisory Committee concluded that, “Potential episodes of psychosis, aggression and cardiac events with attention deficit drugs in children do not warrant a black box warning.”

The committee felt that the cardiovascular events were not of a similar risk in ADHD children as adults, except for those with cardiovascular abnormalities. The committee also declined to endorse a black box for psychiatric events, including aggression, and risk of suicide, according to the FDA Advisory Committee’s web site.

Also parents should understand that the News Media loves the debate, and loves the idea that a medication that is being prescribed to perhaps 3 million children and teens might be forced to wear a “black box” warning on the label. This is the kind of news that sells newspapers.

Physicians, patients, and parents must understand that there are risks to stimulant medications. But they are rare. Stimulant medications do have their place, and when needed should be considered. Stimulant medications should be prescribed with care, and parents should understand that they are not toys, vitamins, or over the counter remedies. The medications used for ADHD are powerful, usually effective, but can sometimes cause serious problems.

There are alternatives that can also be effective without the potential of dangerous side-effects, including diets for ADHD, the nutraceutical Attend’s specific treatment strategies, and EEG Neuro-feedback training.

We have always recommended trying the alternatives (1) diet and (2) Attend strategies before considering medications. Together they are statistically as effective as medications in the treatment of ADHD. Should these interventions not provide the patient with the benefits that he needs, the patient should then consider the available medications for ADHD.

ProDrugs: The Next Generation of ADHD Medications?

Just as 2006 and 2007 saw an increase options for delivery systems of medications for ADHD, the next generation of medications for ADHD may be just around the corner in 2008 and 2009. These NextGen medications are known as ProDrugs, and they have the potential to change the way medications are prescribed to individuals with ADHD.

Since there has been a recent explosion of new ADHD drugs such as Strattera, or new delivery systems such as Daytrana, or “old drugs in new dresses” such as Concerta, why in the world is it necessary to develop any more new drugs for ADHD? Why should we care?

To the extent that new drugs are just “old drugs in new dresses” for a pharmaceutical company to make money, we don’t care. But to the extent that this NextGen of ProDrugs might actually make a difference in people’s lives, we are very interested in learning more.

And given that between 30% and 40% of patients cannot tolerate the side-effects of current stimulant medications, and given that today’s ADHD medications range from about 60% effective (Strattera) to 80% effective (Ritalin), there is a lot of room for improvement in this field. This is why we like Attend, which is not a drug, but is about 70% effective and with few or no side-effects. It is just not well known.

ProDrugs: The Next Generation of ADHD Medications

By developing this next generation of drugs, pharmaceutical companies are betting huge sums of monies that they can develop ADHD drugs that are more efficient for a given individual, and with fewer side-effects. Since there are different types of ADHD, different types of drugs, or drugs that will work on different parts or systems of the brain, will be more efficient than just broad acting CNS stimulants.

What is a ProDrug?

A ProDrug is an inactive precursor of another drug, an inactive precursor to a particular pharmacologic agent. It is a drug that is given in an inactive, or greatly less active form. But once taken, the person’s body metabolizes it into an active form. The person’s body becomes the “delivery system.”

A ProDrug is designed to be more efficient in treatment, by being better absorbed and better utilizied by the body, with less side-effects.

The goal of ProDrugs is for the drug to be highly targeted to a specific system or region of the body, a specific site of action, rather than just impact the entire body or CNS.

Shire Pharmaceuticals, a company that we have been very critical of in the past, is one of the companies leading the way in ProDrug development. Well, actually they are not, but they did by New River Pharmaceuticals for $2,600,000,000 (yes, that is 2.6 Billion dollars). And New River Pharmaceuticals was leading the lay in ProDrug development for ADHD with their drug Vyvanse (lisdexamgetamine dimesylate). The FDA approved Vyvanse as a “novel treatment” for ADHD in February of 2007, and the DEA will classify it as a Schedule II controlled substance.

See http://newideas.net/adhd/medication/vyvanse_shire

From the Shire press release of Feb. 2007:

“VYVANSE is a prodrug that is therapeutically inactive until metabolized in the body. In clinical studies designed to measure duration of effect, VYVANSE provided significant efficacy compared to placebo for a full treatment day, up through and including 6:00 pm. Furthermore, when VYVANSE was administered orally and intravenously in two clinical human drug abuse studies, VYVANSE produced subjective responses on a scale of “Drug Liking Effects” (DLE) that were less than d-amphetamine at equivalent doses. DLE is used in clinical abuse studies to measure relative preference among known substance abusers.

“The FDA approval of VYVANSE is exciting news for Shire as well as for patients, their families, and healthcare providers as it’s an important, novel approach for the treatment of ADHD,” said Matthew Emmens, Shire Chief Executive Officer. “The label we received with the approval letter includes information about the extended duration of effect and abuse-related drug liking characteristics of VYVANSE which illustrate benefits that differentiate this compound from other ADHD medicines. The addition of VYVANSE to our ADHD portfolio reaffirms Shire’s commitment to continue to address unmet medical needs and advance the science of ADHD treatment. Beginning with product launch in Q2 2007, Shire will make VYVANSE our top promotional priority within our ADHD portfolio.”

The big selling point of Vyvanse is that it may reduce the potential for abuse, as ProDrugs are not favored by those intending to abuse stimulants.

In regards to ADHD ProDrugs, admittedly Vyvanse is the only ProDrug that I have heard any lectures on or read anything about, but I don’t want to assume that it is the only ProDrug in development for ADHD. In the studies on Vyvanse, the researchers found that among all of the subjects, the ProDrug was metabolized very consistently in terms of time to optimum therapeutic levels in the body, and in terms of the predictability of the degree to which the ProDrug was utilized by the body.

To put it better, put ten kids in a room who each weigh 100 pounds. Let’s say that they each need treatment with methylphenidate (Ritalin, et al.). The variety of optimal doses in those ten children could range from 5mg per dose to 40mg per dose. But with the ProDrug, the study indicates that nearly everyone of that body weight will be taking the same size does to get the optimum dose.

To put it even more simply, it will be easier for doctors who aren’t paying attention well to get the right dose for the right child the first time. And the response to the drug will be more predictable. Everything will operate more efficiently with a more efficient drug.

In addition to ProDrug development, look for the use of various “Alpha-2 Noradrenergic Receptor Agonists” for the treatment of ADHD in the near future. Tenex (guanfacine) is already in use for ADHD, as well as being an anti-hypertesive and blood pressure medication, but more will be on the way. We will look at this class of medications, and their potential for ADHD treatment, in the near future.

QA: Adderall XR Question

Adderall XR

Question from a Reader:

This summer I took my child off XR adderall, he is not growing and his weight is below average. He is not moody any longer, the ticks are going away and he told me he is not having problems like before with attention. I do not wish to return him to meds.

How can I help him when it comes to school and behavior?

Answer from Editor:

Most of what you mention are things that you have to discuss with your doctor. But I'll do what I can to help you. You may be aware of this week's headlines about stimulants "stunting growth" in kids. I haven't yet read the study yet, but I will soon and it seems that you should too.

Regarding the "tics" that you mention, it is possible that your son suffers from Tourettes Syndrome, perhaps instead of ADHD. People with TS can have the same symptoms of ADHD, but with tics, especially when using stimulant medications. You'll have to check this out with your doctor.

What to do next?

Well, I'd recommend that you use our eating program for about two months
http://newideas.net/adhd/adhd-diet

and Attend and Extress for about two months
http://newideas.net/adhd/attend
http://newideas.net/adhd/different-types-adhd
http://www.vaxa.com/26462/index.cfm?page=636.cfm

and also check to make sure there are no environmental allergens or toxins around that
might be involved:
http://newideas.net/adhd/differential-diagnosis/mercury-chemical-toxicit...

also begin learning about Tourettes Syndrome. I like the old book Tourettes Syndrome and
Human Behavior, by David Commings at the City of Hope (City of Hope Press). Your local
library should have a copy. Its a huge book, but very readable, with about 1/3 of the
book on TS, 1/3 on ADHD, and 1/3 on the brain and treatment options. Again, it is old, so
the medication options have changed. But it is a great place to begin learning to see if
that's really what's going on with your son.

Does this help? I hope so. Please stay in touch.

Doug Cowan Psy.D.

Adderall XR Question

Risperdal for ADHD?

Is Risperdal a medication that is used to treat ADD/ADHD? What are the mental illnesses that it is used for?

Risperdal would not typically be used to treat ADHD, and I have never heard of it being a first drug to try. I suppose there might be reasons if there were a lot of symptoms of anxiety, obsessive-compulsive symptoms, or explosive temper or irritability. Or if the doctor thought that it was really tourettes syndrome, or schizophrenia just breaking out.

It is an interesting question that you ask...

Here are some websites with general information that would be more helpful to you than any answer I might give:

http://www.janssen.com/janssen/products.html
http://www.drugs.com/risperdal.html
http://en.wikipedia.org/wiki/Risperdal
http://www.fda.gov/foi/warning_letters/archive/g4628d.htm

Talk with your doctor and your PHARMACIST if you have more questions.

Doug Cowan

The ADHD Information Library at http://newideas.net
Over 500 Classroom Interventions at http://www.ADDinSchool.com

The information in this email is not to be considered medical advice. Always
consult your own physician or health care provider. The information at the ADHD
Information Library and from its staff is for educational purposes only.

Ritalin

Just the mention of the name "Ritalin" can cause a wide variety of emotional reactions among people.

Some love Ritalin, as they have seen it help a loved one, and will defend it forever.

Others hate it, and see it as a part of the plan of evil psychiatrists to try to drug children and take over the world (yes, really!). They will attack it whenever they can.

Most people simply don't know what to think.

Ritalin for ADHD

Ritalin is a "brand-name" for a medication made from Methylphenidate. Methylphenidate (MPH) is a stimulant used to treat Attention Deficit Hyperactivity Disorder, or ADHD, in both children and adults.

Ritalin, or one of its Methylphenidate cousins, may also be used to treat symptoms of traumatic brain injury, narcolepsy, and even chronic fatigue syndrome (though many other treatments are far better).

Other Methylphenidate-based medications are also discussed in this section, and they include:

• Concerta
• Focalin
• Metadate
• Daytrana

Ritalin as a "brand-name" medication comes in three forms, and in various doses:

• Ritalin: 5 mg, 10 mg, and 20 mg tablets;
• Ritalin SR: 20 mg tablets;
• Ritalin LA: 10 mg, 20 mg, 30 mg, and 40 mg capsules;

Ritalin in the Treatment of ADHD

Stimulants have been around for about 50 years. Overall, they work very well. Ritalin and Dexedrine are moderately beneficial, or very beneficial, for about 70% to 75% of those who try them.

There is an unbelievable amount of research done on children and Ritalin, less with Dexedrine, ADDerall, and Cylert. We have heard that Ritalin is the most widely studied medication prescribed to children in the world, and we would not dispute that claim. It seems that every doctoral candidate writing his dissertation for psychology does something with Ritalin.

Stimulants, whether Ritalin or the amphetamines such as Dexedrine or ADDerall, all have benefits for children and adults with Attention Deficit Hyperactivity Disorder - ADD ADHD.

Ritalin will increase the brain's ability to inhibit itself. This allows the brain to focus on the right thing at the right time, and to be less distracted, and less impulsive. Ritalin will increase the "signal to noise ratio" in the brain.

Ritalin will also increase both gross motor co-ordination and fine motor control. For several years the sales brochure for Ritalin simply had pictures of children's handwriting before Ritalin, and with 10 mg of Ritalin in their system. The changes were dramatic, and physicians wrote a lot of prescriptions for Ritalin.

Ritalin may be "over-prescribed" in America, it may not be. But if it is "over-prescribed" it is because it actually works! If it didn't work, sometimes dramatically, it wouldn't be "over-prescribed."

Are we great advocates for the use of stimulant medications?

No. We would prefer that patients at least try the nutritional medicines like ATTEND and Extress, or EEG Biofeedback training first. However, there is a time and a place for the use of Ritalin. And we want you to have accurate information.

Getting the Most out of Ritalin

Ritalin is a pretty good medication. We have seen hundreds of kids benefit greatly from Ritalin. But doctors and parents must be observant and conservative.

We have also seen some horror stories with Ritalin. It must be used carefully, and started slowly and cautiously. It is not a toy.

Ritalin can cause serious side-effects. Read about Ritalin side-effects here.

We have found that the short-acting pill is better than the timed-release pill. Patients report that the timed-release pill seems to "release" whenever it feels like it, rather then when the patient expects it. So using the short-acting pill gives most patients greater control with the Ritalin.

We have found that the brand name “Ritalin” is much superior to the generic “Methylphenidate.” Generic pills can vary is dosage as much as 20% either way, stronger or weaker. For example, what is a 10 mg Ritalin pill in the generic form may be effectively as little as 8 mg or as much as 12 mg, a 50% potential variation. Always begin your "trial" of medication with the real Ritalin. If that works, then feel free to see if the generic will work as well as the “real stuff.”

Ritalin begins to work in about 15 or 20 minutes. It peaks in effectiveness at 1.5 to 2.5 hours, and lasts for about 3.5 to 4.0 hours.

Some kids have "withdrawals" or a “trough period” from coming off of the dose at about the 4 hour mark. They may "crash" and become irritable, tearful, emotional, or bratty. This lasts for 15 to 30 minutes, and tends to be worse with doses of 15 mg. or more.

The best remedy for this that we've found is a 12 oz. Mountain Dew at about the 3.0 hour mark. The caffeine "deflects" or "flattens out" the angle of withdrawal. This trick works well.

Ritalin Myths

Statements often heard about Ritalin, but are not supported by research, include:

• "Drug treatment should not and need not be indefinite and usually may be discontinued after puberty."

  Most children with ADD ADHD will still benefit from medications through their teenage years, and more than 50% of children with Attention Deficit Hyperactivity Disorder will still benefit from stimulant medications into adulthood.

• "Start with 5 mg twice daily, before breakfast and lunch."

  Studies show that the medications work better if taken with or after meals. Just be consistent as to when you take it.

• "Administration of amphetamines for prolonged periods may lead to drug dependence and must be avoided."

  While this is one aspect of treatment to be concerned about, another side of this is that studies show, over and over again, that (1) ADD ADHD kids who are never treated will have higher rates of drug use than non-ADHD kids, (2) ADD ADHD kids that ARE treated, whether with medications, or biofeedback, or with anything, will have LOWER rates of drug us than non-ADHD kids.

  There is no evidence that using stimulant medications increases rates of drug use among adolescents or adults. Rather, the opposite is true.

FDA Hearings and Warnings About Ritalin

We have lots of discussion about the recent FDA hearings on Ritalin and other stimulant medications that we want you to read and become familiar with.

We also have the "black box warnings" for you to look over.

It is an issue of "full disclosure" to you. These medications can be very helpful. But we recommend that you try Attend, Extress, and the ADHD diet first. They also work well without the potential side-effects of Ritalin.

Ritalin: Side Effects and an Alternative to Ritalin

Ritalin Side Effects

Ritalin (Methylphenidate)

It has been our opinion for years that Ritalin is a good medication. But it can cause problems, sometimes serious side effects, and must be used with caution.

Recent FDA warnings are starting to make us wonder about recommending Ritalin these days. The evidence seems to be mounting against it.

Our Clinical Director Dr. Cowan has worked with over 1,000 children and teens with ADHD over the past 20 years, and hundreds of those ADHD patients were treated with Ritalin.

For about a third of those patients Ritalin made a "day and night" difference. For another third Ritalin was "helpful." For the rest, Ritalin either didn't help significantly, or it actually caused problems. For a few ADHD kids there were significant side effects ranging from loss of appetite, to seizures.

Most of the Ritalin side effect problems observed over the years were due to physicians not being careful with the prescriptions, and prescribing too much Ritalin per dose, especially when first beginning treatment.

Other problems were observed when parents would continue to give the Ritalin to their ADHD kid even when they saw that the medication was causing the child problems. Ritalin is a powerful tool and must be used carefully, if used at all.

Tip for Parents: The short-acting pill is better than the timed-release pill. Also, the brand name "Ritalin" is much superior to the generic "Methylphenidate." Always begin your "trial" of medication with the real stuff. If that works, then feel free to see if the generic will work as well as the "real stuff." Ritalin begins to work in about 15 or 20 minutes. It peaks in effectiveness at 1.5 to 2.5 hours, and lasts for about 3.5 to 4.0 hours.

More Ritalin Side Effects

Some kids have "withdrawals" or a "trough period" from coming off of the Ritalin dose at about the 4 hour mark.

They may become irritable, tearful, emotional, or bratty. This lasts for about 15 minutes, and tends to be worse with Ritalin doses of 15 mg. or more.

The best remedy for this that we've found is a 12 oz. Mountain Dew at about the 3.0 hour mark. The caffeine "deflects" or "flattens out" the angle of withdrawal. This trick works well.

We have seen hundreds of kids benefit greatly from Ritalin. But doctors and parents must be observant and conservative. We have also seen some horror stories with Ritalin. Start slowly and cautiously. It is not a toy. And remember, there are other things that you can do that work as well as Ritalin, and are healthy for you!

Is Ritalin Dangerous?

Here is a link to a site that is strongly opposed to Ritalin use, as the author, Mr. Lawrence Smith, states that his child died as the result of its use.

He claims that there are about 20 deaths reported each year to the FDA's MedWatch program from Ritalin. Although it is hard to believe everything that is on the internet, I do think that you should at least take a minute to look over his site and consider the information.

Here is a copy of the email that Mr. Smith sent to me in 2002.

There are Other Choices

Look at this chart comparing Ritalin to ATTEND and to EEG Biofeedback treatment...

Ritalin is very effective. Ritalin works somewhat differently in the brain than do the amphetamines like Dexedrine or ADDerall. Ritalin seems to primarily impact on longer term vesicular storage of Dopamine, while amphetamines primarily impact the pool of newly synthesized Dopamine. It also has a different effect on Norepinepherine.

Attend is also effective. It has amino acids, essential fatty acids, phospholipids, homeopathic medicines, and more. It is healthy and effective. And it does not require a prescription, and comes with a no-risk trial policy second to none. It either works - or it is free. More information on the natural remedy ATTEND. Here to order ATTEND from VAXA International.

The main side effects of Ritalin that we have observed are loss of appetite (feed a protein shake twice a day to help keep weight up), some irritability or anger (as when you have had too much caffeine), possible short term growth inhibition (though long-term this may not be a problem). Remember, every medication has possible bad side effects, so always closely monitor your child when taking medications!

If there is a problem, don't give the next dose, and call your doctor right away.

Storm in a Western Pill - Fear and Empowerment in ADHD Drug Treatment

Our guest author is Shane Wong. Mr. Wong is the Editor-in-Chief for Juxtaposition Global Health Magazine, a student-run publication based at the University of Toronto. According to the author: "This article will explore how ADHD medication can empower diagnosed patients, and why fears towards such drugs and the pharmaceutical industry persist across North America."

"Ritalin, Ritalin, seizure drugs, Ritalin.” Such is the lunchtime rhyme for a typical school nurse in the U.S. as she trots from class to class, dispensing pills into outstretched hands of young children (01/18/99 - New York Times).

Welcome to the uniquely North American psychotropic environment. A continent featuring a prescription drug market for attention-deficit hyperactivity disorder (ADHD) worth over 2-billionUS annually, and where the number of prescriptions have grown four-fold in 20 years and over 90% of prescriptions worldwide originate.

But when patients as young as two-years-old are prescribed drugs that a government puts in the same category as morphine and cocaine, controversy concerning the use of drug treatment for ADHD is bound to arise. This article will explore how ADHD medication can empower diagnosed patients, and why fears towards such drugs and the pharmaceutical industry persist across North America.

ADHD Diagnosis

Attention Deficit Hyperactivity Disorder (ADHD) is among the most commonly diagnosed behavioural disorder in school-aged children, with prevalence rates ranging from 2% to 7%.

According to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), the standard diagnostic manual for all North American mental health professionals, ADHD is differentiated into two clusters of behavioural symptoms: inattention, as well as hyperactivity and impulsivity.

Problems with attention primarily involve lack of sustained focus, which can manifest as a rapid shift between toys when young children play or a lack of persistence shown by older children during tasks that lack intrinsic appeal or immediate reward. Additionally, children may also have trouble controlling impulsive behaviour, such as speaking out irrationally or engaging in unnecessary risk-taking behaviour. Finally, hyperactivity includes a tendency to fidget excessively, making it often the most obvious feature in young children.

Burden of Disease: In the Classroom

These tendencies naturally contribute to problems in a variety of domains for many children classified as having ADHD. Academically, children with ADHD are more likely to be expelled or suspended, and 25% of ADHD children develop learning disabilities that range from reading disorders to dyscalculia, a very specific math related disorder where individuals have trouble manipulating simple calculations and numbers. Consequently, it is no surprise that researchers found that ADHD is associated with lower rates of high school graduation and post-secondary education.

Burden of Disease: Outside the Classroom

Apparently the sing-song echo of kids in the playground, “sticks and stones may break my bones, but words will never hurt me”, is only partly true. ADHD children not only have higher rates of accidents, but they have a lower sense of self-esteem and self-efficacy due to frequent negative feedback in academic and social settings.

More troublingly, one study found that 30% of ADHD youth also suffer from anxiety disorders, while 11% experience major depression. Due to their often unrestrained and overbearing social behaviour, ADHD children are also less popular among their peers. Using their classmates’ ratings, researchers found that only 1% of 7-9 year-old children with ADHD were of ‘popular’ status, while 52% fell into the ‘rejected’ category.

A Childhood Syndrome?

Contrary to popular belief, many of the symptoms of ADHD remain present throughout an individual’s lifetime. With growing attention towards adults with ADHD, researchers have found many negative outcomes associated with ADHD that are exacerbated in adulthood as individuals are gaining increasing responsibility and autonomy.

Adults with ADHD generally face greater marital and drug abuse problems, and become involved in more serious accidents. For instance, a unique German study revealed that nearly 45% of inmates in a prison facility suffer from ADHD, suggesting an increased risk of run-ins with the law. Furthermore, at the workplace, ADHD adults display lower work ratings and often change jobs more frequently.

Ritalin: An Empowerment Tool?

Given the negative health, social and academic outcomes associated with ADHD, psychostimulant medications such as Ritalin and Adderall offer the potential to empower children and adults by reducing the risk of negative consequences. In a landmark study lasting over 18 years, researchers at the famed Mayo Clinic found that ADHD medication was associated with improved long-term academic success in children with ADHD. Compared to untreated children diagnosed with ADHD, medication improved reading achievement scores, decreased absenteeism, and decreased the likelihood for a child to be retained in a grade. More specifically, children were able to handle general tasks and manage requests better, while increasing academic productivity.

Outside the classroom, treatment with psychostimulants also reduced the risk of substance abuse by about half compared to children without treatment. The growing research into the benefits of psychostimulant treatment suggest that current ADHD medications can empower individuals to achieve success in academic, employment, self-care and social relationships.

Yet, how does this ‘magic’ pill work? With advances of brain imaging technology, researchers have made tremendous progress in illuminating how medication ‘empowers’ at a neurochemical level. Contrary to one of the first coherent descriptions of ADHD in 1902, which attributed the disorder to an “abnormal defect in moral control,” current drug treatments have actually uncovered a characteristic difference in the brains of patients with ADHD, which stems from a lack of dopamine receptors in the attentional network.

Therefore, ADHD psychostimulant treatments, like Ritalin, actually work by increasing dopamine in the brain by blocking re-uptake transporters, in a fashion analogous to a powerful brick that blocks a drainage pipe, preventing neurochemicals from being flushed away. According to our knowledge of dopamine, the enhancement of dopamine signals in the brain helps patients focus and learn.

One theory that can explain the lowered risk of drug abuse, hypothesizes that an increased dopamine signal lengthens ‘the temporal window’ for associating behaviours to consequences, leading to more effective extinction of impulsive behaviours. Psychostimulants were also shown to increase dopamine in brain regions known as the attentional network, leading to a greater level of attention and focus. Based on these findings, psychostimulant treatments appear to empower patients by reducing symptoms at a neurochemical level and minimizing the risks of negative outcomes associated with ADHD.

Long Term Effects of Psychostimulants: Dependency?

Despite the demonstrated benefits of drug treatment, there remain uneasy fears towards the ADHD medication as a result of its potential side-effects. According to fundamental neurobiological principles, the brain will compensate for the artificial changes in brain chemistry caused by drugs.

This suggestion was confirmed in a 2001 brain imaging study that found three months of
psychostimulant treatment in ADHD children significantly reduced the number of dopamine receptors in the attentional network, the very deficit characterizing ADHD brains in the first place. In other words, if children are taken off the medication, it is likely that their ADHD symptoms will worsen, at least in the short-term. Currently, ADHD medication labelling warns for the risk of sudden death in children and adolescents with structural cardiac abnormalities or other serious heart problems, and psychotic symptoms such as hallucinations and delusions.

For Every Action, There is a Reaction: Abuse and New Formulations of Medication

There are also fears directed towards the potential abuse of psychostimulant medication. In 2001, the Journal of the American Medical Association published an article titled: “Pay Attention: Ritalin Acts Much like Cocaine”, confirming that the clinical effects of ADHD drugs are indistinguishable
from cocaine if both are similarly administered. Furthermore, psychostimulants have been abused by students needing to stay awake and study, or hoping to lose weight. As quoted in the New York Magazine, “You swallow Adderall to study, and snort it for fun”.

One survey examining the prevalence of ADHD drug abuse found that more than 16% of students at a liberal arts college had tried Ritalin recreationally and nearly 13% had ‘snorted’ it. According to a 2007 report from US Office of the National Drug Control Policy, prescription drugs are now second only to marijuana when it comes to drug abuse among the college age group.

However, the issue of psychostimulants drug abuse to achieve a ‘high’ has been circumvented by recent advances in drug formulation and delivery. By embedding the psychoactive ingredients within a thick paste, newer psychostimulants such as Concerta prevents drug abusers from snorting or injecting it intravenously to achieve a “high,” limiting the medicine’s street value. Furthermore, a once-a-day formulation administered in the morning before school is less likely to be given away or sold to other student.

Pharmaceutical Industries Role Over the Prescription of Psychostimulants Among the scientific community and media, there is also a fear towards potential abuse and undue influence by the thriving pharmaceutical industry. Until 2004, it was the most profitable industry in the U.S.20 Given the rapid growth of the global market for ADHD drug treatment that has witnessed drug spending rise nine fold between 1993 and 2003, pharmaceutical corporations are undoubtedly major stakeholders in the debate over how to treat ADHD.

With more money spent on ‘marketing and administration’ than ‘research and design,’ there is concern that the pharmaceutical industry can use its vast financial resources to promote medication as the ADHD treatment of choice to patients and physicians.

According to Dr. Marcia Angell, pharmaceutical companies already have “too much” influence over the education of physicians. It has been estimated that the pharmaceutical industry spends over $6 billion annually on marketing to physicians. Sales representatives hired to visit physicians is a common avenue to market the latest drug product. One physician recalls being “offered $100 [to simply] sit and listen for 15 minutes on the telephone” to a pharmaceutical representative talk about ADHD and Adderrall. More troublingly, Dr. Harold Koplewicz of New York University believes sales representatives can influence “prescription practice more than reading a peer-reviewed journal”.

There is also a growing new industry called Medical Education and Communication Companies (MECC), for-profit companies now numbering more than 100 that are supported by pharmaceutical companies and put together educational programs, presentations and teaching materials for physicians.

While representatives of the pharmaceutical companies say their intention is simply to generate goodwill by financially assisting providers of Continuing Medical Education with the costs of the educational programs, studies have found industry-supported educational activities are slanted in favour of the financial supporter's products, and that physicians attending such courses later prescribe these products more often than competing drugs.

Pharmaceutical Industries Influence of Research Publications

Pharmaceuticals also exert influence over research activities through funding. In the United States, 70% of the $5.56 billion that goes into funding for clinical research comes from the biopharmaceutical industry. According to a recent survey of 107 U.S. medical schools, a startling 62% of industry-funded research permits the sponsor to alter the study design after an agreement has been executed while 80% allow the sponsor to own the data.

One telling example of the consequences of this conflict of interest, between scientific research and the pharmaceutical industry’s interests, is told by Dr. William Pelham, a leading ADHD research author to over 275 publications.

In 1997, Dr. Pelham was funded by the McNeil Pharmaceuticals to conduct a study to gain FDA approval for the ADHD medication Concerta. The original intent was to measure both the side effects and main effects of the drug, but the study was fundamentally flawed because the participants were screened to ensure they were already taking and responding well to a similar ADHD medication. By stacking the studies with patients already successfully taking stimulants, McNeil Pharmaceuticals ensured the participants would be unlikely to register side-effects.

Furthermore, Dr. Pelham claims that there was direct pressure from the company to tweak the
findings in the paper. Recalling a conference call with senior executives of the pharmaceutical company funding the study, he was “pushed to delete a paragraph in the article” advocating combined treatment (medication and behavioural), and pressured to water down or eliminate other phrases that did not dovetail into their interests. In the end, the paper was accepted without his knowledge and published with his name on it.

Today, Concerta is on the market, but Dr. Pelham argues that it reflects how companies are “really pushing meds without telling the full picture”. As Dr. Angell, former editor-in-chief of the New England Journal of Medicine, asserts, pharmaceutical industry’s control over the evaluation of their own product constitutes a fundamental conflict of interest. The growing partnership between the pharmaceutical industry and scientists may potentially compromise that of intellectual honesty in clinical research.

Marketing of Quick Fixes

The pharmaceutical industry in North American has also begun to directly market ADHD drug treatments to families. In 1996, the United Nations International Narcotics Control Board ANNUAL REPORT 1995 publicly raised concerns regarding the active promotion of psychostimulant treatment by the parent support group Children and Adults with Attention Deficit/Hyperactivity Disorder, who had received a donation of more than $1 million from the American pharmaceutical industry.

Further in 2001, the American ADHD pharmaceutical industry began launching direct-to-consumer advertisements in magazines and on television promoting ADHD drug treatments. This ended nearly 30 years of the global industry’s observance of the 1971 Convention on Psychotropic Substances, an international treaty discouraging consumer advertising of controlled substances.

While advertisements can inform parents of treatment options and raise awareness about the disorder, marketing tends to drive up parental demands for specific drugs regardless of whether they are the best treatment option for a particular child afflicted with the disorder. A study in 1999 showed that 80 percent of patients who asked for an advertised drug were prescribed it. Moreover, advertising may create the impression that medication is an “easy quick fix” for the often confusing and frustrating behaviour of ADHD children. With a for-profit pharmaceutical industry thriving in a capitalist economy, the central concern is that industry-funded research, education and marketing may push physicians, researchers and families towards only one way of thinking about the problem; that the only solution to ADHD lies in a daily pill for lifetime, coincidentally a highly profitable solution.

Broader Range of Empowerment Tools

In a 2000 review of the use of stimulants for ADHD children, the American Medical Association asserted that “medication . . . should never be regarded as the whole treatment.” Apart from a fear for potential side-effects, the problem is that stimulant drugs can only provide short-term management of behaviour as they do not confer benefits once the drug has been withdrawn. Use of drugs over an entire lifetime in order to manage behavioral symptoms is not, however, an attractive option to those lacking medical insurance and the financial resources to purchase daily medication for their child.

Among the plethora of non-medication treatments that includes herbal medicines to dietary modifications, one of the most promising treatments is neurofeedback. Underlying this treatment is the finding that electroencephalogram (EEG) patterns, brain electrical activity as measured by
electrodes on the scalp, are different in those with ADHD. More specifically, all children with ADHD show increased theta (4-8 Hz) compared to beta (16-20 or 13-21 Hz) relative to healthy age peers. Using an EEG net, brain electrical activity can be converted into visual or acoustic signals that are continuously fed back in real time.

Since finding that conditioning brain activity patterns is possible, changes that are made in the desired direction are rewarded. For children, such training is often framed as a type of computer game. In essence, neurofeedback is an operant conditioning procedure in which patients learn to gain self-control over their own brain activity to produce EEG activity associated with being calm, alert while minimizing activity associated with ADHD symptoms.

Self-regulation through neurofeedback, which simply involves the client learning to produce brain wave patterns that are associated with being calm and focused, has advantages over medication. Neurofeedback offers a non-medicinal alternative for the management of ADHD symptoms and produces long-lasting effects 10 years later in children who successfully changed brain wave patterns.

It is also non-invasive and without negative side-effects, thus making it a much more benign intervention. More importantly, several research studies have concluded that that neurofeedback is an efficacious treatment for ADHD with symptom reduction equivalent to what can be achieved with Ritalin.

However, the treatment is not without its drawbacks. The typical treatment requires a time commitment of about 40 sessions that last about an hour-long each. Neurofeedback also requires the child to be motivated to complete the full treatment, although increasing attention to designing fun computer games in this context may be helpful.

Ultimately, for those who suffer from constant setbacks and failures due to inattention, hyperactivity or impulsivity, drug treatment can be a very empowering tool. ADHD drug treatment can act as a powerful stimulant for learning which is often important for success in school, at the workplace, or interpersonally within a social environment.

However, it is critical to remain mindful of the financial pressures exerted by the pharmaceutical industry on physicians, research and families. With recent research suggesting alternative treatments such as the effectiveness of neurofeedback, a multi-modal treatment that incorporates medication and neurofeedback may be the most effective longterm strategy to manage or even treat ADHD.

Biography:
Shane Wong is the Editor-in-Chief for Juxtaposition Global Health Magazine, a student-run publication based at the University of Toronto. The most recent issue “Fear and Empowerment in Global Health” can be downloaded from www.juxtapose.ca in PDF format, including all of the footnotes which we had to exclude here.

Shane will be graduating with a BSc in Human Behavioural Biology and Psychology from University of Toronto in 2008. He hopes to pursue a career in paediatric psychiatry, with a concentration on ADHD and autism spectrum disorders. He is also interested in working internationally and exploring how socio-cultural forces shape our understanding of mental health.

The views expressed in this article are not necessarily those of the ADHD Information Library or its staff, but are printed for the educational benefit of our readers, and for the encouragement of young authors and researchers. Keep up the good work. The ADHD Information Library.

Strattera: Is it for You?

Strattera

Strattera is a recent medication, with a lot of publicity, and a lot of marketing money, which makes it seem like the best medication since antibiotics were developed. But its short history is filled with controversy.

There are a lot of serious questions to be answered about Strattera:

• Just how effective is Strattera?
• What are the short-term side effects of Strattera?
• What are the long-term side effects of Strattera?
• How does it compare to Stimulants in terms of effectiveness, or safety?
• How does Strattera compare to alternatives natural medicines like ATTEND in terms of effectiveness, or safety?

Strattera Information

Strattera is a norepinephrine reuptake inhibitor, a class of ADHD treatment that works differently from the other ADHD medications available.

Strattera works by selectively blocking the reuptake of norepinephrine, a chemical messenger, or neurotransmitter, by certain nerve cells in the brain.

This action increases the availability of norepinephrine, which is thought to be essential in regulating impulse control, organization and attention.

See our discussion on norepinephrine here.

Taking Strattera Carefully

Take Strattera exactly as directed by your doctor.

Strattera offers flexible dosing, once or twice daily. Discuss a convenient schedule for taking Strattera with your doctor.

Do not take Strattera with any other medications, even over-the-counter medications! You must talk with your doctor first! Talk to the Pharmacist too!

Our reports indicate that there can be serious problems taking anti-depressants with Strattera.

Our reports indicate that there can be serious problems taking even Benedryl with Strattera.

Our reports indicate that small doses of stimulants may be OK with Strattera, and may enhance treatment.

Lilly to Put Suicide Warning on Strattera Label

Thursday, September 29, 2005 from Reuters News - Foxnews.com

CHICAGO — Eli Lilly and Co. (LLY) Thursday said it will add strong warnings to its label for Strattera used to treat attention-deficit/hyperactivity disorder, including the risk of suicidal thoughts among children and adolescents.

Strattera will now carry a "black box" warning the strongest required by U.S. regulators.

Such warnings typically hurt sales of products by raising concern among doctors and patients about the safety of a drug.

The Indianapolis drug maker said a review of clinical trials data identified a small but statistically significant increased risk of suicidal thoughts among Strattera-treated children and adolescents.

About Strattera (atomoxetine)

Our reports indicate that it takes 4 to 6 weeks for Strattera to work well (to reach therapeutic levels).

We believe that Lilly will experience the same problems that VAXA has in getting people to stick with Attend, which also takes 4 to 6 weeks to work well. The problem is that parents usually only give an intervention 2 weeks to work, and then they move on to something else.

Stimulants, when prescribed with the correct dose, work in about 20 minutes, so parents tend to go back to using them, even with the harsher side-effects. After all, the parents don't experience the unpleasant side-effects - the kids do. But the parents do enjoy the benefits of the medication around the home.

Our reports also indicate that Strattera, like Attend, has fewer "ups and downs" than stimulants.

There can be some stomach problems, but there is less of a "rebound" effect. By the way, for reducing the "rebound" effect of stimulants, try drinking a Mountain Dew at the 3 hour mark (for Ritalin). This seems to help a great deal to eliminate the "crashing" off a dose of Ritalin, and make a smooth landing.

In one of the Strattera studies the researchers reported the following adverse events occurring in some patients:

• Rhinitis (33.3%),
• Headache (20%),
• Anorexia (16.7%),
• Dizziness (16.7%).

No serious side effects were observed and no patients stopped medication or discontinued the study due to adverse events.

There have been reports of prostate problems in men with ADHD from Strattera.

In each of six clinical trials, Strattera was statistically superior to placebo in reducing the symptoms of ADHD in children, adolescents and adults. The positive effects of Strattera were seen for overall ADHD symptoms including hyperactive /impulsive symptoms and inattentive symptoms.

Ummm. Coffee is better than placebo.

Would you take a medication that was not better than a placebo?

Remember, Attend makes statistically significant improvements on the computerized TOVA CPT test in 70% of subjects, and 80% improvement on Parent Rating Scales; Ritalin makes statistically significant improvements on the computerized TOVA CPT test in 85% of subjects.

Is Strattera better than either of these?

One of the studies [Heiligenstein J, Kaplan S, Harder D, et al.: Atomoxetine: Clinical outcomes in pediatric ADHD with comorbid ODD.] reported the following:

"The results showed that ADHD RS, CGI and CPRS ADHD Index scores from baseline to endpoint were markedly improved in patients taking atomoxetine compared to the placebo group, with no significant difference attributable to the presence or absence of comorbid ODD.

"In the atomoxetine group, clinical response was 65.4 percent for those with ODD and 58.9 percent for those without the comorbid disorder versus 36.4 percent and 29.3 percent in the placebo group (all p values less than or equal to 0.007).

ATTEND had a statistically significant response from 70 percent of those without the comorbid disorder.

"The most commonly reported treatment-emergent adverse events were headache, rhinitis and abdominal pain. Diarrhea was the only statistically significant side effect that occurred more often in children with comorbid ODD when compared with those without ODD."

It looks on the surface like Strattera may be very helpful in treating children and teens with Oppositional Defiant Disorder and ADHD. However, the results may not be as good as either Attend combined with Extress, or stimulants.

In six placebo-controlled studies, two in children, two in children and adolescents, and two in adults, Strattera significantly reduced core symptoms of ADHD, and was well tolerated. In all studies, participants met Diagnostic and Statistical Manual, 4th Edition (DSM-IV-TR), criteria for ADHD.

Both Strattera and older treatments, like methylphenidate (the active ingredient in Ritalin and Concerta), are effective in treating ADHD.

However, Strattera is the first FDA-approved treatment for ADHD that is not a stimulant and is not a controlled substance under the Controlled Substance Act. As a non-controlled substance, Strattera provides the convenience of physician samples and phone-in refills.

Study: ADHD Preschoolers Improve with Low Doses of Medication

From the National Institute of Mental Health 2007

The first long-term, large-scale study designed to determine the safety and effectiveness of treating preschoolers who have attention deficit/hyperactivity disorder (ADHD) with methylphenidate (Ritalin) has found that overall, low doses of this medication are effective and safe. However, the study found that children this age are more sensitive than older children to the medication's side effects and therefore should be closely monitored. The 70-week, six-site study was funded by the National Institutes of Health's National Institute of Mental Health (NIMH) and was described in several articles in the November 2006 issue of the Journal of the American Academy of Child and Adolescent Psychiatry.

"The Preschool ADHD Treatment Study, or PATS, provides us with the best information to date about treating very young children diagnosed with ADHD," said NIMH Director Thomas R. Insel, MD. "The results show that preschoolers may benefit from low doses of medication when it is closely monitored, but the positive effects are less evident and side-effects are somewhat greater than previous reports in older children."

Methylphenidate is the most commonly prescribed medication to treat children diagnosed with ADHD. But its use for children younger than 6 years has not been approved by the Food and Drug Administration. And until PATS, very few studies—and no large-scale ones—have been conducted to collect reliable, consistent data to help guide practitioners treating preschoolers with ADHD.

The 303 preschoolers enrolled in the study ranged in age from 3 to 5 years. The children and their parents participated in a pre-trial, 10-week behavioral therapy and training course. Only those children with the most extreme ADHD symptoms who did not improve after the behavioral therapy course and whose parents agreed to have them treated with medication were included in the medication study. In the first part of the medication study, the children took a range of doses from a very low amount of 3.75 mg daily of methylphenidate, administered in three equal doses, up to 22.5 mg/day. By comparison, doses for school-aged children usually range from 15 to 50 mg total daily.

The study then compared the effectiveness of methylphenidate to placebo. It found that the children taking methylphenidate had a more marked reduction of their ADHD symptoms compared to children taking a placebo, and that different children responded best to different doses.

"The best dose to reduce ADHD symptoms varied substantially among the children, but the average across the whole group was as low as 14 mg per day," said lead author Laurence Greenhill, M.D., of Columbia University/New York State Psychiatric Institute. "Preschoolers with ADHD may need only a low dose of methylphenidate initially, but they may need to take a higher dose later on to maintain the drug's effectiveness."

To ensure the safety of the very young children involved, the study was governed by a strict set of ethical standards and additional review boards. The children's health was monitored carefully and repeatedly throughout the study's duration. Their parents were repeatedly consulted for consent prior to every step of the program. The researchers also reviewed the teacher ratings of the children who attended preschool at various stages in the study.

Similar to 1999 results found in NIMH's Multimodal Treatment Study of Children with ADHD (MTA study), and other studies on school-aged children, the medication did appear to slow the preschoolers' growth rates. Throughout the duration of the study, the children grew about half an inch less in height and weighed about 3 pounds less than expected, based on average growth rates established prior to the study.

Currently, no data exist that track long-term growth rate changes among preschoolers with ADHD who are medicated with methylphenidate. However, a five-year-long follow-up study is underway to track the children's physical, cognitive, and behavioral development, as well as health care services the family is using to care for the child. Those data will be available in two to three years.

Finally, 89 percent of the children tolerated the drug well, but 11 percent—about 1 in 10 children—had to drop out of the study as a result of intolerable side effects. For example, while some children lost weight, weight loss of 10 percent or more of the child's baseline weight was considered a severe enough side effect for the investigators to discontinue the medication. Other side effects included insomnia, loss of appetite, mood disturbances such as feeling nervous or worried, and skin-picking behaviors. Despite concerns that stimulants may increase blood pressure or pulse, any changes seen in the children's blood pressure or pulse were minimal.

"The study shows that preschoolers with severe ADHD symptoms can benefit from the medication, but doctors should weigh that benefit against the potential for these very young children to be more sensitive than older children to the medication's side effects, and monitor use closely," concluded Dr. Greenhill.

PATS was conducted by researchers at Columbia/New York State Psychiatric Institute, Duke University, Johns Hopkins University, New York University, the University of California Los Angeles, and the University of California Irvine, in collaboration with NIMH staff under a cooperative agreement.

The National Institute of Mental Health (NIMH) mission is to reduce the burden of mental and behavioral disorders through research on mind, brain, and behavior. More information is available at the NIMH website.

The National Institutes of Health (NIH) - The Nation's Medical Research Agency - includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

Greenhill L, Kollins S, Abikoff H, McCracken J, Riddle M, Swanson J, McGough J, Wigal S, Wigal T, Vitiello B, Skrobala A, Posner K, Ghuman J, Cunningham C, Davies M, Chuang S, Cooper T. Efficacy and Safety of Immediate-Release Methylphenidate Treatment for Preschoolers With ADHD. J Am Acad Child Adolesc Psychiatry. 2006 Oct 4; [Epub ahead of print]

Wigal T, Greenhill L, Chuang S, McGough J, Vitiello B, Skrobala A, Swanson J, Wigal S, Abikoff H, Kollins S, McCracken J, Riddle M, Posner K, Ghuman J, Davies M, Thorp B, Stehli A. Safety and Tolerability of Methylphenidate in Preschool Children With ADHD. J Am Acad Child Adolesc Psychiatry. 2006 Oct 4; [Epub ahead of print]

McGough J, McCracken J, Swanson J, Riddle M, Kollins S, Greenhill L, Abikoff H, Davies M, Chuang S, Wigal T, Wigal S, Posner K, Skrobala A, Kastelic E, Ghuman J, Cunningham C, Shigawa S, Moyzis R, Vitiello B. Pharmacogenetics of Methylphenidate Response in Preschoolers With ADHD. J Am Acad Child Adolesc Psychiatry. 2006 Oct 4; [Epub ahead of print]

Kollins S, Greenhill L, Swanson J, Wigal S, Abikoff H, McCracken J, Riddle M, McGough J, Vitiello B, Wigal T, Skrobala A, Posner K, Ghuman J, Davies M, Cunningham C, Bauzo A. Rationale, Design, and Methods of the Preschool ADHD Treatment Study (PATS). J Am Acad Child Adolesc Psychiatry. 2006 Oct 4; [Epub ahead of print]

Swanson J, Greenhill L, Wigal T, Kollins S, Stehli A, Davies M, Chuang S, Vitiello B, Skrobala A, Posner K, Abikoff H, Oatis M, McCracken J, McGough J, Riddle M, Ghuman J, Cunningham C, Wigal S. Stimulant-Related Reductions of Growth Rates in the PATS. Stimulant-Related Reductions of Growth Rates in the PATS. J Am Acad Child Adolesc Psychiatry. 2006 Oct 4; [Epub ahead of print]

See this NIMH page.

NIMH publications are in the public domain and may be reproduced or copied without the permission from the National Institute of Mental Health (NIMH). NIMH encourages you to reproduce them and use them in your efforts to improve public health. Citation of the National Institute of Mental Health as a source is appreciated.

PLEASE SEE OUR RESPONSE TO THIS STUDY on Preschoolers and ADHD Medications.

Study: Methylphenidate (MPH - Ritalin) and Brain Activation

Methylphenidate, Ritalin, and "Working Memory Functions" in ADHD

June 2007

Do Stimulants Have a “Reverse Effect” on People with ADHD?

Its one of the classic ADHD myths, that stimulants have a “reverse effect” on those with ADHD than on those without ADHD. How else can you explain that a non-ADHD person takes stimulants and gets “spun up” while a person with ADHD is actually on purpose treated with stimulants to make them “calm down”?

A recent study with MRI technology looked at how stimulant medications actually impact the brain in both those with ADHD and those without.

Children, teens, and adults with ADHD have problems with attention, self-control, and restlessness or hyperactivity. They also may show deficits in what is called "working memory functions."

These "working memory functions" are what maintain and manipulate the information that we take in from the world aroud us. This "working memory" is crucial for every-day functioning. Without it functioning well, we are total "space cadets."

Methylphenidate (MPH) is the stimulant medication that makes Ritalin, and a few other ADHD medications. It is a potent medication that may improve the performance in several areas of the brain, and in cognitive tasks.

Recently some researchers, using MRI technology, looked at the impact of MPH on "working memory functions" using a study group of six boys with ADHD, and also six boys without ADHD.

Each subject was tested twice, once with Methylphenidate in his system, and once without. During imaging in the MRI Scanner, all participants performed a working memory task that became increasingly difficulty.

The results of the EASIEST task showed no differences between the groups of boys, or whether they had medication or not. Everyone did pretty well on the easiest task with or without MPH.

But in the MORE difficult task, the ADHD subjects performed better when medicated than they did without medication. And with the MPH the fMRI images showed increased activity in the frontal regions of the brain. This is consisten with what is known about stimulants.

In the MOST difficult task, performance of medicated patients was better than that of non-medicated patients.

Likewise, brain activation increased under medication, especially in frontal and parietal regions of the brain. These areas are thought to be involved in "working memory processes." These specific activation patterns in the ADHD boys with medication were very similar to the patterns seen in the boys without ADHD, also with medication. In other words, stimulants have the same effects in the brains of people with ADHD, and without ADHD.

The study also indicated that MPH improves the "functional networks of working memory" by increasing the brain activity in parietal and frontal regions. It also pointed out that the improvement is best seen in difficult tasks.

It also shows that MPH does not have some kind of "reverse effect" on people with ADHD, as some myths claims. Rather, the MPH activation patterns are similar to the ones observed in the healthy boys. All the stimulant medication does is improve the performance of certain regions of the brain so that the brain functions more normally, and is better at focusing, problem solving, and having self-control.

Of course, we would rather that you try an alternative solution to stimulant medications for the treatment of ADHD, and our recommendation is Attend by VAXA. It is not quite as effective as Ritalin - see our comparison - but it does work very well and has no harmful side-effects.

The Organization for Human Brain Mapping is located in Minneapolis, MN.

VYVANSE Approved by FDA - Big Money Involved Too!

Vyvanse Update

A couple of months ago we reported that Shire Pharmaceuticals was looking to receive approval on their third medication for the treatment of ADHD named VYVANSE, and now they are receiving it from the FDA.

This new medication will go along with Shire's two other products for ADHD, Daytrana, a methylphenadate patch worn by children on the hip, and the somewhat controversial ADDerall XR. All three products are once per day dosing.

The product is expected to be on the market by the summer of 2007, and is expected to generate a lot of money for Shire.

Shire Pays Huge Money

In fact, Shire is so fond of stimulants for the treatment of ADHD that they paid $2,600,000,000 (yes, that's 2.6 Billion dollars) for New River Pharmaceuticals, the company that actually developed Vyvanse. Read more in the press release below about the new medication, the money, and the companies.

Press Release - VYVANSE - February 23, 2007

FOR IMMEDIATE RELEASE
Shire and New River Pharmaceuticals Announce FDA Approval of the First and Only Stimulant Prodrug VYVANSE ™ (lisdexamfetamine dimesylate) as a Novel Treatment for ADHD

Basingstoke, U.K., Philadelphia, PA and Radford, VA – FEBRUARY 23, 2007 – Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) and its collaborative partner New River Pharmaceuticals Inc. (NASDAQ: NRPH) announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for VYVANSE (lisdexamfetamine dimesylate, formerly known as NRP104), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

On February 20, 2007 Shire and New River announced an agreement whereby Shire will acquire New River for approximately $2.6 billion in an all cash transaction unanimously recommended by the Boards of both companies. The transaction is the subject of another press release issued February 20, 2007.

VYVANSE is a prodrug that is therapeutically inactive until metabolized in the body. In clinical studies designed to measure duration of effect, VYVANSE provided significant efficacy compared to placebo for a full treatment day, up through and including 6:00 pm. Furthermore, when VYVANSE was administered orally and intravenously in two clinical human drug abuse studies, VYVANSE produced subjective responses on a scale of “Drug Liking Effects” (DLE) that were less than d-amphetamine at equivalent doses. DLE is used in clinical abuse studies to measure relative preference among known substance abusers.

“The FDA approval of VYVANSE is exciting news for Shire as well as for patients, their families, and healthcare providers as it’s an important, novel approach for the treatment of ADHD,” said Matthew Emmens, Shire Chief Executive Officer. “The label we received with the approval letter includes information about the extended duration of effect and abuse-related drug liking characteristics of VYVANSE which illustrate benefits that differentiate this compound from other ADHD medicines. The addition of VYVANSE to our ADHD portfolio reaffirms Shire’s commitment to continue to address unmet medical needs and advance the science of ADHD treatment. Beginning with product launch in Q2 2007, Shire will make VYVANSE our top promotional priority within our ADHD portfolio.”

Randal J. Kirk, New River’s Chairman and Chief Executive Officer, remarked, “VYVANSE’s approval signals a new era in the treatment of ADHD. Upon product launch, patients will have a novel treatment option combining the effectiveness of a stimulant – long considered the gold standard in ADHD medicines – with other potential benefits.”

The FDA has proposed that VYVANSE be classified as a Schedule II controlled substance.

This proposal was submitted to and accepted by the U.S. Drug Enforcement Administration (DEA). A final scheduling decision is expected from the DEA following a 30-day period for public comment. Once VYVANSE receives final scheduling designation, the label will be available. Pending final scheduling designation, product launch is anticipated in Q2 2007.

VYVANSE will be available in three dosage strengths: 30 mg, 50 mg and 70 mg, all indicated for once-daily dosing.

New River developed VYVANSE as a new ADHD medication designed to provide lower potential for abuse, in which d -amphetamine is covalently linked to l -lysine, a naturally occurring amino acid. The combination is rapidly absorbed from the gastrointestinal tract and converted to d -amphetamine, which is responsible for VYVANSE’s activity.

Joseph Biederman, MD, director of Pediatric Psychopharmacology at Massachusetts General Hospital, was lead investigator on the pivotal clinical studies testing lisdexamfetamine dimesylate for the treatment of ADHD.

These large multi-site studies showed that the drug significantly reduced ADHD symptoms throughout the day with a predictable tolerability profile. “Our studies showe