Recall of Meridia Will Be Debated by FDA This Week
This week, an independent advisory panel to the FDA will consider whether a recall of Meridia should be issued due to the risk of heart attacks associated with the weight-loss drug.
On Wednesday, the FDA panel will review the side effects of Meridia, as well as its potential benefits, and then recommend whether the FDA should allow the medication to remain on the market. The meeting follows a nearly year-long safety review conducted by the FDA, which was launched after a study published last November found that Meridia users could face an increased risk of heart problems, while the medication helped them achieve only a small amount of weight loss.
After the study, called SCOUT, was published, the European Medicines Agency quickly pulled the drug from the market. The FDA added more stringent warnings and began trying to decide whether there should be a Meridia recall in the United States as well.
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The FDA has released Meridia briefing materials in preparation for this week’s meeting. Although the advisory committee recommendations are not binding, the FDA usually follows the suggestions of their panels.
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 no longer actively promotes the drug in the U.S. and sales are dropping worldwide. Last year, Meridia pulled in about $100 million across the globe, with sales of $30 million in the U.S.
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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