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Meridia Heart Risks Taken Up by FDA Panel

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A Food & Drug Administration (FDA) advisory panel is meeting today to determine the fate of the diet drug Meridia. The weight loss medication has been linked to a higher risk of heart attacks and strokes. Meridia has already been pulled from the European market. In the US, it is contraindicated for use in patients with a history of heart problems. The FDA is asking its advisory panel to weigh Meridia’s risk of a major cardiovascular problem in people who don’t already have heart disease, but have diabetes, and whether any risk could be mitigated by tracking patients’ vital signs during treatment. The panel will be asked to recommend whether the drug should stay on the market, with or without further restrictions, or be pulled. The FDA is not legally required to follow the recommendations of its advisory panels, but it usually does so. This new safety review was prompted by a study called Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) which found that Meridia was associated with 16 percent more major cardiovascular side effects compared to a placebo. That study followed almost 10,000 patients for as long as six years. SCOUT involved patients who were 55 years of age or older, overweight or obese, and had a history of heart disease or type 2 diabetes plus one additional cardiovascular risk factor. It does appear that the FDA is leaning towards taking some action in regards to Meridia. A 170-page FDA briefing document posted on the agency’s Web site contains analyses by half a dozen

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agency scientists, at least two of whom seem to favor withdrawing the drug. One reviewer points out that the weight reduction benefits of Meridia – patients lose on average 4 percent of their body weight – have not been significant. Another reviewer pointed out that deaths continue to be reported with the Meridia in young patients with no history of heart problems. Of note, when Meridia was approved for use in the US 13 years ago, the majority opinion of the FDA’s outside advisers had opposed it because of its potential for heart problems.

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