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 suspended marketing authorization for all obesity medicines containing sibutramine in January 2010.
Meridia was approved by the FDA in November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least five percent of their body weight than people on placebo who relied on diet and exercise alone.
"Meridia's continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke," says John Jenkins, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, in a statement. "Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs."
Abbott says it is having ongoing discussions with regulatory authorities in countries where sibutramine is marketed and anticipates concluding those discussions over the coming days.
- see Abbott's statement
- get the Health Canada release
- check out the FDA's announcement
- here's the notice from Australia's Therapeutic Goods Administration
- get more from the WSJ