FDA Drug Safety and Risk Management Advisory Committee
Center Date Time Location
CDER February 9, 2006
February 10, 2006
8:00 a.m. - 5:00 p.m.
8:00 a.m. - 3:00 p.m. Holiday Inn Gaithersburg
Two Montgomery Village Ave.
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. The few controlled clinical studies of longer term drug treatment of ADHD provided little information on cardiovascular risks.
On February 9, 2006, the committee will be asked to discuss approaches that could be used to study whether these products increase the risk of adverse cardiovascular outcomes.
On February 10, 2006, 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.
Background material and meeting information will become available no later than one business day before each meeting day (Simply scroll down to the appropriate committee heading).