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Dec. 3, 2009

New Evidence of Dangers Associated With Weight-Loss Drug Meridia Makes an Immediate FDA Ban Imperative

For the Second Time This Decade, Public Citizen Petitions FDA to Ban Meridia

WASHINGTON, D.C. - New research shows that Meridia, a popular weight-loss drug, has caused a significantly increased number of heart attacks, strokes, resuscitated cardiac arrests or deaths in obese patients getting the drug and should be pulled from the market immediately, Public Citizen said today in a petition to the Food and Drug Administration (FDA).

This is Public Citizen’s second petition to have Meridia banned; the FDA rejected the first four years ago, saying it was awaiting results of an ongoing trial. The results are in, and they show that the drug’s dangers significantly outweigh its benefits.

“If the FDA truly intends to operate as a public health agency, then it should acknowledge that the continued approval of this drug cannot be justified based on science,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “The FDA should therefore tell Abbott to pull Meridia from the market immediately.”

Public Citizen first petitioned the FDA to ban sibutramine, the active ingredient in Meridia, on March 19, 2002. The organization based its request on results of pre-approval clinical trials that demonstrated increases in blood pressure, pulse rate and palpitations in obese patients taking the drug. 

Despite scientific evidence that these patients were three times more likely to experience clinically significant electrocardiogram changes than obese patients taking placebos - coupled with the minimal benefit of an average six-and-a-half pound weight-loss difference between the two groups - the FDA approved the drug in 1997. By March 2003, there were reports to the FDA’s adverse reaction system of 49 cardiovascular deaths among patients taking Meridia. Twenty-seven of the 49 (55 percent) were in people younger than 50 years old. The number is likely higher, as the FDA estimates that only one in 10 adverse reactions to drugs are reported to the agency. 

In responding to Public Citizen’s 2002 petition, the FDA said that until a large, randomized study could provide more conclusive results, Meridia would continue to be sold. Now the early results are in from a persuasive study called SCOUT, in which 10,000 people across Europe participated. The recently released results of this study reveal a significant increase in heart attacks, strokes, resuscitated cardiac arrests or deaths in obese patients 55 or older with known or undetected cardiovascular disease who used sibutramine, compared with those given a placebo. Both groups were on the same weight management program. 

Based on the new findings from the SCOUT study and Public Citizen’s updated figures based on an analysis of FDA data, Public Citizen calculates that there have been 84 post-approval cardiovascular deaths of patients taking Meridia. This includes 32 patients who were 50 or younger and 11 patients 30 or younger. Public Citizen urges the FDA to take immediate action to ban sibutramine. About 294,000 prescriptions for Meridia were filled in the past 12 months.

READ Public Citizen’s petition.

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