October 13, 2010 – The anti-obesity drug sibutramine will be withdrawn from the U.S. market after a study found it had cardiovascular safety risks. Sibutramine (Meridia), made by Abbott, is a prescription medicine used to help overweight or obese people lose weight.
Abbott is voluntarily withdrawing the drug at the request of the U.S. Food and Drug Administration (FDA).
The FDA's request is based primarily on the results of the SCOUT study, a 10,000 patient, six-year study requested by European regulatory authorities 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 SCOUT results are in contrast to the vast body of sibutramine data for the on-label patient population, including 46 controlled clinical trials and more than 6 million patient years of use accumulated over 13 years during which the product has been available. These data fail to confirm the excess cardiovascular risk found in the SCOUT study.
The voluntary withdrawal follows an 11-month process, beginning in November 2009, when Abbott promptly notified the FDA of the SCOUT preliminary results. The European Medicines Agency (EMA) suspended marketing authorization for all anti-obesity medicines containing sibutramine in January 2010.
The company also conducted several analyses that concluded that people with pre-existing cardiovascular disease should not take sibutramine. Meridia can cause serious side effects including large increases in blood pressure or heart rate in some people. Patients should call their doctor right away if they have symptoms of high blood pressure such as headache, dizziness or blurred vision.
For more information: www.sibutramine.com