WARNING LABELS FOR RITALIN AND CONCERTA TO BE STRENGTHENED BY FDA IN RESPONSE TO REPORTS OF ADVERSE PSYCHIATRIC AND CARDIOVASCULAR SIDE-EFFECTS

Methylphenidates (generic) are a class of drugs used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The most common forms of the drug are Ritalin (made by Novartis) and the long-acting version known as Concerta (made by Johnson & Johnson).

These drugs, along with amphetamines like Adderall, Adderall XR, and Strattera, are widely prescribed for the treatment of ADHD. Last year, 7.8 million prescriptions for Concerta and 2.5 million for methylphenidate were written in the United States alone.

While these drugs appear to be effective, they come with relatively serious warning labels. In fact, the FDA posted the following Alert on February 9 in response to Health Canada’s suspension of Adderall XR sales due to a concern about reports of sudden unexplained deaths in children taking both Adderall and Adderall XR.

“FDA ALERT [2/9/2005] – Sudden Deaths in Children
Health Canada has suspended marketing of Adderall XR products from the Canadian market due to concern about reports of sudden unexplained death (SUD) in children taking Adderall and Adderall XR.  SUD has been associated with amphetamine abuse and reported in children with underlying cardiac abnormalities taking recommended doses of amphetamines, including Adderall and Adderall XR.  In addition, a very small number of cases of SUD have been reported in children without structural cardiac abnormalities taking Adderall.  At this time, FDA cannot conclude that recommended doses of Adderall can cause SUD, but is continuing to carefully evaluate these data.”

Thus, the FDA has had every reason to monitor adverse event reports very carefully with respect to all of the drugs used in the treatment of ADHD. Of course, an adverse event report neither identifies a side-effect nor confirms one’s existence. It may truly be something to watch or it may simply be an occurrence unrelated to the drug being taken.

Even when a link to a particular prescription drug is not proven, the FDA and the manufacturer often mention these events on the label. Recent high profile drug withdrawals, pressure from consumer advocacy groups and lawmakers, and a move toward greater disclosure of adverse information about prescription drugs have prompted the FDA to be more proactive in terms of identifying and following potential safety problems.

Recently, the FDA has received reports of patients experiencing a variety of psychiatric events while being treated with Ritalin or Concerta. These include hallucinations, suicidal thoughts, psychotic behavior, aggression, and violent actions. (Eli Lilly has reported observing increased aggression and hostility in a small number of Strattera users and has added that information to the U.S. and European label for the drug.)

As a result of these reports, the FDA plans to strengthen the warning labels on Ritalin, Concerta, and all other methylphenidate products and has also asked its pediatric advisory committee to review the matter. The agency has not confirmed any link between the adverse events and the drugs and it has not indicated that a description of the events will be included in the warning. 

Any labeling change, however, is likely to be put off until all ADHD medications are re-evaluated. This would probably not occur until early 2006.

In addition to the possible psychiatric problems associated with the drugs, the FDA is also concerned over reports of cardiovascular problems including hypertension, arrhythmias, chest pain, and tachycardia in Concerta users. As a result, further steps may be taken to investigate these issues by way of data base studies or new safety trials.

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