New Warnings for ADHD Meds

FDA requires drug manufacturers to include warnings about cardiovascular risks and psychiatric side effects on the label of every ADHD drug on the market.

New rules issued by the FDA require drug manufacturers to include warnings about cardiovascular risks and psychiatric side effects on the label of every ADHD drug on the market. The agency took the action following reports of serious, sometimes fatal, cardiovascular problems, as well as reports of psychiatric complications, such as mania or paranoia, in a small number of patients taking the drugs.

The agency urged patients to discuss the risks with a doctor—and to be sure to point out any history of heart ailments or psychiatric problems.

"Medicines approved for the treatment of ADHD have real benefits for many patients, but they may have serious risks as well," said Steven Galson, M.D., director of the agency's Center for Drug Evaluation and Research. "The FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new patient medication guides to inform doctors and patients about these concerns."

The warnings are to be included on labels and in literature included with the medicines. For more information, go to fda.gov/cder/drug/infopage/adhd.