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Meridia Could be Pulled from US Market

Sep 14, 2010 | Parker Waichman LLP

US health regulators are considering removing the diet drug Meridia (sibutramine) from the market, or subjecting it to stronger warnings because of its association with heart attacks and strokes. A Food & Drug Administration (FDA) advisory panel is scheduled to discuss Meridia tomorrow. The weight loss drug has already been pulled from the European market over safety concerns.

When Meridia was approved for use in the US 13 years ago, the majority opinion of FDA’s outside advisers had opposed it because of its potential for heart problems, the Associated Press said. The drug is currently contraindicated for use in patients with a history of heart problems.

According to an FDA report released yesterday, a study called Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) 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. Patients who recently had a heart attack or stroke, or had poorly controlled congestive heart failure were not included in the study

According to the Associated Press, a 170-page FDA review posted online yesterday contains analyses by half a dozen 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.

According to The Wall Street Journal, 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.

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