FDA: Medications Used to Treat ADHD Need Better Warnings About Cardiovascular and Psychiatric Risks

On February 21, 2007, the U.S. Food and Drug Administration (FDA) sent letters to manufacturers of all medications used to treat attention deficit hyperactivity disorder (ADHD), ordering them to warn patients of possible cardiovascular and psychiatric risks. Manufacturers must include new FDA-approved language in Patient Medication Guides to reflect these warnings within the next 30 days.

Strokes and heart attacks have been reported in adults with particular risk factors. Serious cardiovascular adverse events - including sudden death - have been reported in patients with underlying heart problems or defects.

Psychiatric risks include the development of hallucinations, delusions, and mania, even in patients without a history of these or other psychiatric problems. The risk for these events is approximately 1 per 1000.

There has been dissent within the FDA over the issue of getting information about these risks to the public. In 2006, the FDA's Drug Safety and Risk Management Committee called for placing "black box" warnings on drugs used to treat ADHD, due to concern over possible heart risks. However, an FDA pediatric advisory panel decided instead that adding information on cardiovascular and psychiatric risks to labels would suffice. The FDA ultimately went with the latter decision.

The drugs which are required to carry the new warnings include: 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. Strattera must carry a black-box warning, stating that it may cause children to have suicidal thoughts.