Abbott Laboratories is voluntarily withdrawing sibutramine from the market based on an increased risk of myocardial infarction and stroke in those taking the drug, a risk that outweighs “any benefit from the modest weight loss observed with the drug,” the Food and Drug Administration announced Oct. 8.
“Physicians are advised to stop prescribing Meridia to their patients,” Dr. John Jenkins, director of the office of new drugs at FDA’s Center for Drug Evaluation and Research (CDER), said during a press briefing.
The decision was based on results from the Sibutramine Cardiovascular Outcomes (SCOUT) trial, a postmarketing study conducted at the request of European health authorities, which found that the risk of major adverse cardiovascular events (a composite of nonfatal heart attack, nonfatal stroke, resuscitation after cardiac arrest, and cardiovascular death) was 16% higher among sibutramine-treated patients compared with those on placebo. After 60 months, those on sibutramine had lost a small amount of weight on average compared with those on placebo.
Sibutramine was withdrawn from the European market in January, based on the SCOUT results.
Most of the patients in SCOUT – who had pre-existing cardiovascular disease, type 2 diabetes, or both – would not be considered candidates for treatment, based on the labeling in the United States. But during the briefing, Dr. Gerald Dal Pan, director of CDER’s Office of Surveillance and Epidemiology, said that “these results, combined with other available safety data raised serious questions about Meridia’s safety for all patient groups.”
The FDA recommends that clinicians contact patients taking sibutramine and advise them to stop. Clinicians also are advised to evaluate these patients for cardiovascular events if they present with any signs or symptoms of cardiovascular disease, according to the agency.
The announcement was made almost 13 years after sibutramine was approved by the FDA – and less than a month after half of the members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee panel recommended that it be taken off the market.
Small average increases in heart rate and blood pressure associated with treatment were a concern when sibutramine was approved; however, the drug was approved because of the cardiovascular and other health benefits expected with weight loss, and because heart rate and blood pressure can be easily monitored, Dr. Jenkins explained.
About 100,000 people in the United States currently take sibutramine, Dr. Dal Pan said. At the advisory panel meeting in September, the FDA presented outpatient prescription data, showing an almost 81% drop in sibutramine prescriptions in the United States between 1998 and 2009.
Also on Oct. 8, the FDA advised individuals not to take “Slimming Beauty Bitter Orange Slimming Capsules,” a product sold over the Internet. The product contains “excessive amounts of sibutramine that may be dangerous to people who have a history of cardiovascular disease,” according to FDA, which noted there have been reports of serious side effects associated with the product, including elevated blood pressure, headaches, vomiting, and insomnia.
The FDA is encouraging clinicians to report adverse events associated with sibutramine to the MedWatch program at 800-332-1088 or www.fda.gov/medwatch/.