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Posts Tagged ‘sibutramine’

Meridia to Be Removed from U.S. Market

by admin on: May 27th, 2011

Meridia, a name brand drug also known as sibutramine, was voluntarily removed from the U.S. by the drug???s manufacturer ??? Abbott Laboratories. As reported in a Washington Post article dated October 8, 2010, this announcement was made by Abbott Laboratories in response to clinical data that demonstrated that this product led to an increased risk of heart attack and stroke in patients taking this medication.

Originally, Meridia was approved by the U.S. Food and Drug Administration in 1997 as a therapy for weight loss and the maintenance of weight loss. With the removal of Meridia and other previous drugs, there are far fewer pharmacological tools that remain approved as weight-loss drugs on the U.S. market. In fact, the FDA recommended that two experimental drugs intended for weight-loss (lorcaserin and Qnexa) not be approved for the U.S. market.

Meridia was indicated as being effective as an adjunct therapy complementing exercise and a diet restriction. Initial clinical studies of Meridia indicated that the additional weight loss that could be attributed to the drug was, at a minimum, five percent of a patient???s body weight.

However, there have been several concerns raised against Meridia ??? most of these concerns were related to Meridia evoking an increase in patient???s blood pressure. Further adding to concerns was the results from the Sibutramine Cardiovascular Outcomes Trial (SCOUT) that reported Meridia increased the risk for a patient experiencing a serious adverse cardiovascular event (e.g. non-fatal heart attack and non-fatal stroke) by 16 percent.In addition to the reported side effects from the SCOUT study, the weight loss that occurred in patients administered Meridia were relatively small when compared with the placebo treated patients.

The director of the Office of New Drugs at the FDA stated that the availability of Meridia is not justified when you consider the relatively small positive effect of Merida versus the level of increased risk.