ADD drug makers told to warn patients of risks

Last Updated: 2007-02-21 13:22:13 -0400 (Reuters Health)

WASHINGTON (Reuters) - Manufacturers of drugs for attention deficit disorders should alert patients to possible cardiovascular and psychiatric risks from these medicines, U.S. health officials said on Wednesday.

The U.S. Food and Drug Administration said it told the drugmakers to develop patient-friendly guides that explain the risks and include them with the drugs.

"Medicines approved for the treatment of attention deficit hyperactivity disorder (ADHD) have real benefits for many patients but they may have serious risks as well," Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

Some patients with attention deficit disorder, may also have hyperactivity (ADHD). Drug used to treat these conditions include: Ritalin, Novartis AG; Adderall, Shire Plc; Strattera, Eli Lilly and Co.; and Concerta, Johnson & Johnson.

"An FDA review of reports 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 stroke and heart attack in adults with certain risk factors," an agency statement said.

"Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 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," the FDA added.