FDA Panel Divided on Whether to Recall Meridia
A panel of experts convened by the FDA were split down the middle on Wednesday when trying to decide whether to recommend that Meridia be removed from the market over concerns that it increases the risk of heart attacks while providing very little weight-loss benefits.
The split vote came during a meeting of an FDA advisory committee whose purpose was to examine the benefits and side effects of Meridia, and then recommend to the agency how to proceed with the drug. Half of the 16-member committee voted in favor of a Meridia recall, six voted to restrict sales and add a “black box” warning to the label, and two decided that only the warning and some patient monitoring would be the correct course of action.
The meeting followed a nearly year-long FDA safety review initiated after researchers determined that Meridia may increase the risk of heart problems while showing minimal weight loss benefits. There has already been a Meridia recall in Europe, which occurred shortly after the research report, known as SCOUT, was published. The FDA will now decide on its own whether to keep the drug on the U.S. market, but usually follows the guidance of their advisory committees.
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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.
Abbott Laboratories attempted to convince the 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, a recall could make the company more vulnerable to potential Meridia lawsuits.
Following the meeting, Abbott Laboratories issued a press release saying that the company still believes there are patients who can benefit from Meridia.
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, filed 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.
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