October 8, 2010
Abbott Laboratories announced today that the pharmaceutical company is voluntarily withdrawing the weight loss drug Meridia (sibutramine) from the U.S. market at the request of the U.S. Food and Drug Administration (FDA).
The drug withdrawal was in response to an FDA request after the agency recommended against the continued use of Meridia (sibutramine) due to cardiovascular risks.
“Abbott believes sibutramine has a positive risk/benefit profile in the approved patient population, but will comply with the FDA’s request,” Abbott said in a release.
The FDA requested the market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). In November of 2009, Abbott notified the FDA of preliminary SCOUT results showing that patients taking sibutramine were at increased risk for heart attack and stroke. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared to another given placebo.
“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,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER). “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.”
On September 15, 2010, the FDA’s sixteen-member Endocrinologic and Metabolic Drugs Advisory Committee reviewed sibutramine data, with eight advisors voting to pull the drug from the market and eight advisors voting for it to remain on the market with increased warnings on the label.
“The patients in the European SCOUT trial did not have the same characteristics as the patients for the approved indication in the United States; however, these results, combined with other available safety data raised serious questions about Meridia’s safety for all patient groups,” said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology in CDER.
The FDA first approved Meridia in 1997. The FDA estimates that 100,000 people in the U.S. are currently taking Meridia.
In 2002, the consumer advocacy group Public Citizen petitioned the FDA to remove Meridia from the market because of cardiac deaths. In 2005, the FDA responded to the petition, denying action.
“The FDA’s decision today to ask pharmaceutical maker Abbott to withdraw the drug is commendable, but dangerously too late for all of the victims of its unacceptable risks,” said Dr. Sidney Wolfe, Director of the Public Citizen’s Health Research Group. “Since then, [the petition in 2002] more than 3 million prescriptions have been filled for Meridia, with many patients inevitably having had heart attacks or strokes because of its known toxicity.”
The FDA also issued an alert today warning consumers not to take the nutritional supplement Slimming Beauty Bitter Orange Slimming Capsules because they contain sibutramine, the same ingredient as Meridia. Consumers may have purchased Slimming Beauty over the internet from Beautiful Health Inc., formerly LL Health and Beauty. They may also have acquired Slimming Beauty sample packets distributed by individuals at community events. The product and the sample packets are falsely labeled as “100% Herbal.” The sample packet label is misleading because it indicates that it is a natural vitamin and calcium capsule for use in children as young as 2 years old.