FDA Black Box Warning Labels on ADHD Medications

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ADHD Medications and the FDA

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.

This book section: ADHD Medication Issues and Research

Douglas Cowan, Psy.D., MFT is a licensed Marriage and Family Therapist in Tehachapi, CA who has been a counselor to children, teens, and adults helping them to overcome ADHD, find relief for depression or anxiety, and solve other problems in life since 1989. He served on the medical advisory board to the company that makes Attend and Extress from 1997 through 2011, and he is the Editor of the ADHD Information Library online resource at http://newideas.net/. His weekly ADHD Newsletter goes out to 9,500 families. Visit his website at http://DouglasCowan.me for more information on achieving greater health, personal growth, Christ-centered spirituality, stress management, parenting skills, ADHD, working out the stresses of being a care-giver to elderly parents and also being a parent to teenagers, or finding greater meaning in retirement years, Dr. Cowan can be a valuable resource to you.

Counselor counseling Tehachapi for ADHD, depression, anxiety, and more.

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Parents Caught in the Middle as FDA Committee Debates ADHD Medications 2006

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2006 : Parents Caught in the Middle as FDA Committee Debates ADHD Medications

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.

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