Meridia Recall Issued Due to Heart Attack And Stroke Risks

Federal regulators have decided that the weight-loss drug Meridia is too dangerous to stay on the market, due to the risk of heart attack and stroke. 

The FDA announced a Meridia recall today, calling on Abbott Laboratories to pull the drug from shelves. FDA officials said that the side effects of Meridia, which has been linked to an increased risk of cardiovascular problems, combined with very little actual weight loss benefits, made giving the drugs to consumers unjustified.

The decision comes after a nearly year-long FDA safety review which culminated in September with a split decision by an FDA advisory committee on whether the drug should be recalled or not. There has already been a recall of Meridia issued in Europe, which occurred shortly after a research report, known as SCOUT (Sibutramine Cardiovascular Outcomes Trial), was published. The same report led the FDA to start its safety review.

Meridia (sibutramine), which is manufactured by Abbott Laboratories, was approved by the FDA in 1997 as a prescription-only weight loss supplement for obese patients with other risk factors such as diabetes, high cholesterol and controlled blood pressure.

Last month, Abbott Laboratories attempted to convince the FDA advisory panel to use sales restrictions and warnings instead of banning the drug. But the company no longer actively promotes the medication in the United States and only had $30 million in domestic sales last year. Globally, the drug brought in about $100 million. However, the Meridia recall could make the company more vulnerable to potential Meridia lawsuits.

Researchers conducting SCOUT found that Meridia increased the risk of serious heart events, such as heart attacks and strokes, by 16%, while finding only a small difference in the weight loss between people given Meridia and those given a placebo. The FDA said that the SCOUT data and the agency’s subsequent review led it to the decision to ask Abbott Laboratories to voluntarily remove Meridia, which it agreed to do.

The recall coincided with a FDA drug safety communication released today that recommended against the continued use and prescription of Meridia.

“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 Dr. John Jenkins, the FDA’s director of the Office of New Drugs. “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 Laboratories released a press release saying that the company disagreed with the FDA’s position, but would comply. The company said that the SCOUT results conflicted with numerous other Meridia drug trials which did not find heart problems.

Some consumer advocate groups have been calling for a recall of Meridia for years. In December 2009, Public Citizen petitioned the FDA to recall Meridia due to the SCOUT trial findings. It is the second time the non-profit has asked the FDA to take Meridia off shelves. The first petition, filed in 2002, was denied by the FDA. The drug is listed as a “Do Not Use” drug on the Public Citizen’s “Worst Pills, Best Pills” list.