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FDA investigates popular weight loss drug, Meridia
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The Food and Drug Administration is investigating the possibility that the weight loss drug, Meridia, may increase the risks of cardiovascular events. The cardiovascular events include heart attack and stroke.
The official name of the study is a mouthful - Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event - or SCOUT for short. It was started in 2002 with 10,000 participants that were over 55 years-old, obese, and had a history of cardiovascular events or diabetes. Some of the participants were given Sibutramine (Meridia) and the rest were given a sugar pill placebo.
The preliminary findings revealed that those taking Meridia encountered cardiovascular events at a rate of 11.4 percent compared to 10 percent of the participants taking the placebo. The FDA did note that warnings with the drug do state that it should not be taken by people with a history of heard disease, stroke, heart rhythm problems, or congestive heart failure.
A spokesman for Abbott, the maker of Meridia, told Dow Jones that the drug wouldn't be prescribed for almost 90% of the participants in the study. "Abbott's assessment is that the data do not indicate a change in the safety profile of [Meridia] when used in the approved patient population," he said.
Sibutramine first gained FDA approval in 1997 as a prescription drug to aid in weight management. Clinical trials have shown that it significantly effects total weight loss and weight loss maintenance.
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