An advisory panel convened by the FDA to determine how to research possible heart risks from ADHD drugs took the unprecedented step of demanding that the agency label all ADHD drugs with a black box, its most serious risk warning for pharmaceutical products. Voting 8-7 in favor of the recommendation, the committee took the action after FDA medical officers described reports of 25 sudden deaths among people taking stimulants like Ritalin, mostly among children. Preliminary analysis of millions of health records suggests ADHD drugs like Ritalin might increase the risks of strokes and serious arrhythmias in children and adults.

Nearly 4 million adults and children take stimulant drugs to treat attention deficit disorder and hyperactivity, and committee members stated they wanted to slow explosive growth in the drug’s use. Arthur Levin, director of the Center for Medical Consumers in New York City and a member of the panel that voted on the committee’s recommendation, said it would be unethical for the committee to discuss the obvious risks of Ritalin and other drugs without making a very strong public warning about the uncertainty and risks of the drugs, given their popularity. More than 30 million prescriptions for Ritalin and the other ADHD drugs, Concerta and Adderall, are written annually.

Dr. Thomas Fleming, a professor of biostatistics at the University of Washington and also a member of the panel, said stimulants like Adderall, Concerta and Ritalin may be far more dangerous to the heart than even Vioxx or Bextra, drugs that were withdrawn recently from the market because of their ill effects on the heart. Vioxx and Bextra have both been linked to an increase risk of adverse events like heart attacks, stroke, sudden cardiac death, and Stevens-Johnson syndrome, a rare debilitating skin disorder.

Source: Gardiner Harris, “FDA panel wary of effects of stimulants; Committee wants stricter labeling on drugs like Ritalin,” New York Times, February 10, 2006.