January 05, 2006
FDA to examine potential heart risks of ADHD drugs
The FDA has asked its Drug Safety and Risk Management advisory committee to examine the potential cardiovascular risks of attention deficit hyperactivity disorder drugs (ADHD) following reports of sudden deaths, stokes, heart attacks and hypertension in children and adult patients.
“Cases of sudden death and serious adverse events including hypertension, myocardial infarction, and stroke have been reported to the agency in association with therapeutic doses of drugs used to treat Attention Deficit Hyperactivity Disorder (ADHD) in both pediatric and adult populations,” a posting to the FDA’s Web site read. “The few controlled clinical studies of longer term drug treatment of ADHD provided little information on cardiovascular risks.”
The committee is scheduled to meet Feb. 9 and 10 in Gaithersburg, Md.
“The issue of drug treatment of attention deficit disorder in children has been a controversial one without this issue of cardiovascular risk too. It adds another concern to what will certainly be an interesting conversation,” Arthur Levin, the FDA committee’s consumer representative told the Associated Press.
The FDA posting failed to mention specific drug names. However, the most widely used include Shire’s Adderall XR, and Novartis’ Ritalin.
On Feb. 9, the committee will be asked to discuss approaches that could be used to study whether ADHD drugs increase the risk of adverse cardiovascular outcomes, the FDA said. On Feb. 10, the committee will be briefed on developments in the Office of Drug Safety and will receive updates on the Drug Safety Oversight Board and agency actions for the COX-2 selective nonsteroidal anti-inflammatory Drugs (NSAIDs) and the risk management program for the isotretinoin products.