Drug and medical-device maker Abbott Laboratories (ABT) announced Friday that it will voluntarily withdraw its controversial obesity drug Meridia, (sibutramine) from the U.S. market at the request of the Food and Drug Administration because of concerns it increases the risk of heart attacks and strokes. Abbott will pull the drug from the Canadian and the Australian markets as well. It was removed from European markets in January 2010.
The FDA's request was based primarily on the results of a six-year study, called Scout, of approximately 10,000 patients. The study was requested by European regulatory authorities as a post-marketing commitment.
The trial found a 16% increase in the risk of serious heart events in a group of patients given Meridia compared to another group given placebos, the FDA explained. Those serious events included nonfatal heart attacks, nonfatal strokes, the need to be resuscitated once the heart stopped, and deaths.
Although the group of patients in the trial was different than the patients for the approved indication in the U.S., the FDA felt it was prudent to pull the drug, which it approved in 1997, from the market, especially given the minimal weight loss it achieves.
"Meridia's continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke," said Dr. John Jenkins, director at the FDA's Center for Drug Evaluation and Research.
The Abbott Park, Ill.-based drug maker said in a statement that it believes Meridia has a positive risk/benefit profile in the approved patient population, but it will comply with the FDA's request.
Abbott is having ongoing discussions with regulatory authorities in other countries regarding sibutramine, it said. It anticipates concluding those discussions in the coming days.
Abbott shares were apparently unaffected by this decision, as the removal of Meridia will not impact the company's bottom line much. Meridia's sales have been declining since the cardiovascular risk was revealed. Last year, Abbott had sales of $30.8 billion in 2009, but according to Reuters, expected just $30 million in U.S. sales of Meridia in 2010.
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