Alert Patients to possible risks of cardiovascular and psychiatric adverse effects.

The US Food and Drug Administration, FDA, has directed the makers of 15 drugs approved to treat attention deficit hyperactivity disorder (ADHD) to include information in the product labeling alerting patients about possible risks of cardiovascular and psychiatric adverse effects. ADHD -- characterized by inattention, hyperactivity and impulsivity -- affects as many as 7 percent of school-age children and 4 percent of adults in this country. (Information from the U.S. Food and Drug Administration)

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.

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.

FDA recommends that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).

As part of the Agency’s ongoing regulatory activity, in May 2006 the FDA directed manufacturers of these products to revise product labeling for doctors to reflect concerns about adverse cardiovascular and psychiatric events. These changes were based on recommendations from the FDA Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee. To help patients understand these risks, an additional part of this revised labeling process is the creation of a Patient Medication Guide for each individual product.

The draft Patient Medication Guides for each product can be found at
http://www.fda.gov/cder/drug/infopage/ADHD/default.htm

(Source for this story) http://www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html

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