The agency had said it planned to review Abbott's Meridia, which has been pulled from the market in Europe on concerns about cardiovascular side effects; however, scheduling the session on Sept. 15, a day before Arena's meeting, sets up a situation similar to last month, when the same panel held a two-day safety review of Avandia before evaluating Qnexa.
The Avandia meeting's focus on safety concerns is thought to have contributed to the Endocrinologic and Metabolic Drugs Advisory Committee ultimately recommending that the FDA reject Vivus's Qnexa because of potential safety issues. The panel cited the lack of long-term safety data on a drug that could be used by millions of Americans for an indefinite period.
