FDA REQUESTS PATIENT MEDICATION GUIDES FOR ADHD DRUGS

The FDA has issued letters to manufacturers of all attention-deficit/hyperactivity disorder (ADHD) products asking them to implement new medication guides, saying it is concerned about cardiovascular risks and adverse psychiatric symptoms.

A review of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of strokes and heart attacks in adults with certain risk factors, the agency said.

Another FDA review revealed a slight increased risk with these products — approximately one in 1,000 — for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason or becoming manic, even in patients who did not have previous psychiatric problems.

Manufacturers have a 30-day deadline to comply with this request. Thomas Laughren, director of the FDA's Division of Psychiatry Products, said that although the core language of the medication guides is standard, each one had to be tailored to each individual drug. "We expect the final language to be worked out over the next month or so," he said, adding that companies have already implemented labeling changes in the warning sections for these drugs.

The drugs affected by the request are Adderall, Adderall XR, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Focalin XR, Metadate CD, Methylin (oral solution), Methylin (chewable tablets), Ritalin, Ritalin SR, Ritalin LA and Strattera.