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Attention Deficit Drugs Move FDA Warnings
WASHINGTON – The FDA said it has requested that all makers of drugs used to treat attention deficit hyperactivity disorder warn patients the products could cause psychiatric problems and raise the risk of heat attacks and strokes.
The FDA is asking drug makers to adopt medication guides, to be dispensed with each prescription, that spell out the risks associated with the drug and ways to prevent problems. The FDA written guides also include information on the drug and how it should be taken.
Last year, the FDA asked drug maker to strengthen warnings on ADHD drug labels discussing rare but increased risks for psychiatric problems, heart attacks and strokes. A drug’s label is directed at – and written for – health-care professionals.
People with ADHD have difficulty concentrating or staying on a task to the extent that it causes impairment in academic, work or social settings. About 3% to 7% of U.S. school age children are affected by ADHD along with about 4% of adults, according to the FDA.
The strengthened warnings followed recommendations by outside panels of medical experts that backed stronger warnings and medication guides directed at patients.
The medication guides apply to 15 products, including Shire Pharmaceuticals Group PLC’s Adderall, Johnson & Johnson’s Concerta, Eli Lilly & Co.’s Stratera and Novartis AG’s Ritalin. Which is also available as a generic.
Tom Laughren, the FDA’s psychiatry-products division director, said the likelihood of developing psychiatric or cardiovascular problems is rare. The risk of a psychiatric event, like hearing voices or becoming manic, is about 1 in 1,000 patients. The risk of heart attacks and strokes isn’t really known and is based on about two-dozen reports of sudden deaths in patients taking ADHD drugs from about 1992 to 2005.
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