Concerta Approved as Adult ADHD Medication

The FDA was busy last week as it approved two drugs for use in adult disorders, including an ADHD medication. The FDA approved the drug Concerta for use in adult ADHD, and approved the first generic versions of Risperdal (risperidone) tablets to treat schizophrenia, bipolar disorder, and other psychiatric conditions. Here we will focus on the approval of Concerta for adults with ADHD.

Concerta is a CNS stimulant medication is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and now adults up to the age of 65. It is thought that stimulants work by helping to increase dopamine and norepinephrine, and perhaps blood flow, in the brain.

Concerta is a timed-release form of methylphenidate (Ritalin is made from methylphenidate). This is why people like it. Instead of having to take two or three doses of Ritalin each day, with the Ritalin “ups” and “downs” through the day, they can get roughly the same benefits all day long from one Concerta dose in the morning. Concerta has a half-life of 3.5 hours, which is about twice as long as Ritalin.

It is recommended that children and teenagers begin Concerta with just a small dose (18 mg/day), but the FDA is permitting adults to start with either 18 mg/day or 36 mg/day. We are not medical doctors, so we don’t want to say anything more on this than that you should always start with a small dose and see how you do before jumping to a bigger dose of a medication for ADHD. We’d say this for any stimulant, but especially a methylphenidate product.

By the way, the 18 mg/day dose of Concerta is equivalent to a 5 mg dose of Ritalin, twice or three times per day.

Besides, there are differing opinions by doctors on what the optimum dosage for adults actually is, or even how to figure it out. Some doctors will just stay with the recommended formulas used for children, and figure “x mg of methylphenidate per each kg of body weight.” But this ignores the fact that a teenager’s metabolism is different from a child’s, and certainly an adult’s metabolism is different from either a teenager’s or a child’s. So I’m not sure that the standard formulas used for children are helpful for adults. Often adults need far less medication, per kg of body weight, than children require for an optimal dose.

This is where tools like the TOVA test are extremely helpful, as an adult can take the medication, wait a few hours, and be tested on the TOVA to see if he/she is a responder to the medication, and if that particular dose was “optimal” or not. These computerized testing tools are about 20 years old now, and yet few practices use them still. Too bad.

Although Concerta is more convenient than Ritalin, you will still have to be careful. Here are the official precautions to consider:

WARNINGS AND PRECAUTIONS

• Serious Cardiovascular Events: Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Stimulant products generally should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems.
• Increase in Blood Pressure: Monitor patients for changes in heart rate and blood pressure and use with caution in patients for whom an increase in blood pressure or heart rate would be problematic.
• Psychiatric Adverse Events: Use of stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no prior history, or eacerbation of symptoms in patients with pre-eisting psychiatric illness. Clinical evaluation for Bipolar Disorder is recommended prior to stimulant use. Monitor for aggressive behavior.
• Seizures: Stimulants may lower the convulsive threshold. Discontinue in the presence of seizures (5.3)
  Visual Disturbance: difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
• Long-Term Suppression of Growth: monitor height and weight at appropriate intervals in pediatric patients
• Gastrointestinal obstruction with pre-eisting GI narrowing
• Hematologic monitoring: Periodic CBC, differential, and platelet counts are advised during prolonged therapy

Adverse Reactions

• The most common adverse reaction in double-blind clinical trials (>5%) in children and adolescents was abdominal pain upper.
• The most common adverse reactions in double-blind clinical trials (>5%) in adult patients were decreased appetite, headache, dry mouth, nausea, insomnia, aniety, dizziness, weight decreased, irritability, and hyperhidrosis.
• The most common adverse reactions associated with discontinuation (t1%) from either pediatric or adult clinical trials were anxiety, irritability, insomnia, and blood pressure increased.