The Food and Drug Administration has denied a petition by a consumer group to ban the prescription weight-loss drug Meridia (sibutramine) made by Abbott Laboratories Inc.
The petition, filed by Public Citizen in March 2002 and renewed in September 2003, asserted that Meridia was related to heart attacks and strokes. It cited 49 heart-related deaths and at least 126 serious cardiovascular adverse reactions resulting in hospitalization in patients taking Meridia. Ten of the 19 cardiac deaths were in people 50 or younger, including three women under the age of 30.
In a statement released Wednesday, Public Citizen said: “Once again, the FDA is siding with a large drug company, much as the agency did several years ago with Merck concerning Vioxx, when it failed to demand a black box warning on that drug.”
Public Citizen added: “How many more dangerously flawed decisions will the FDA make before the Congress repeals the Prescription Drug User Fee Act, which brings the agency ever closer to – and makes the agency less vigilant over – the companies that give it almost $200 million a year in funding?”
An independent review of Meridia by researchers from the University of Washington, published one year ago, the authors concluded that: “Weight loss with sibutramine was associated with modest increases in heart rate and blood pressure. … There was no direct evidence that sibutramine reduces obesity-associated morbidity or mortality. … Thus, we conclude that there is insufficient evidence to accurately determine the risk-benefit profile for sibutramine.
(via Public Citizen)
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