FDA Panel to Review Side Effects of Meridia, Whether to Issue Recall

An FDA advisory panel will look at the side effects of Meridia, Abbott Laboratories’ weight loss drug, and recommend whether the drug should be pulled from the market.

On September 15, the FDA’s Endocrinologic and Metabolic Drugs advisory committee will review the risks and benefits of Meridia, distributed by Abbott Laboratories. The drug came under FDA scrutiny after clinical trials suggested that Meridia can increase the risk of heart attacks, strokes and other cardiovascular problems. In the wake of the study, called SCOUT, Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of Cardiovascular Event, the European Union issued a Meridia recall in January.

The FDA advisory committee’s decisions are nonbinding for FDA drug reviewers, although the agency usually follows its advisory committees’ recommendations.

Meridia (sibutramine) 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.

In November 2009, the FDA announced that they were reviewing potential heart problems from Meridia after data suggested that side effects of the drug may cause users to suffer a higher number of cardiovascular events, such as heart attacks, strokes, resuscitated cardiac arrest or death.

The SCOUT study was originally done in hopes of showing that weight loss through the use of Meridia actually lowered the risk of cardiovascular events; instead the preliminary data suggested that Meridia side effects actually increase the risk.

Researchers looked at 10,000 patients who were obese and over 55 years old with a history of heart disease or type 2 diabetes and other risk factors. In preliminary results reported to FDA in mid-November, researchers found that 11.4% of patients suffered Meridia heart problems, including heart attack, stroke, resuscitated cardiac arrest and death, compared to only 10% of patients given a placebo. The researchers reported that the result was higher than expected.

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