Abbott pulls Meridia in multiple markets

The FDA Abbott Laboratories is voluntarily withdrawing Meridia from the U.S. market following concerns that the drug may increase risk of serious cardiovascular events in patients with heart problems. In addition, the company is pulling the drug from the Canadian and Australian markets.

At the request of the FDA, Abbott Laboratories is voluntarily withdrawing Meridia (sibutramine) from the U.S. market following concerns that the drug may increase risk of serious cardiovascular events in patients with heart problems. In addition, the company is pulling the drug from the Canadian and Australian markets. Meridia is known as Reductil in Australia.

The FDA's request is based primarily on the results of the six-year SCOUT study, which involved roughly 10,000 patients and was requested by European regulatory authorities as a post-marketing commitment to evaluate cardiovascular safety in high-risk patients. The majority of these patients had underlying cardiovascular disease and were not eligible to receive sibutramine under the current labeling.

The voluntary withdrawal follows an 11-month process, beginning in November 2009, when Abbott promptly notified FDA of the SCOUT preliminary results immediately after receiving them. The European Medicines Agency s