The obesity drug, Meridia orÂ Sibutramine, is being voluntarily withdrawn byÂ Abbott LaboratoriesÂ from the US and Canadian markets.
The reason for the withdrawal is an increased risk of stroke andÂ heart attackÂ shown by clinical trial data, according to theÂ FDAÂ or USÂ Food and Drug Administration.
In November 1997, Meridia (Sibutramine) was approved by the FDA for maintenance of weight loss and weight loss in obese people. The drug was approved because people who took it during trials showed a five percent loss ofÂ body weight, compared to people who didn’t.
Both groups used exercise and diet, so the better results were not due to the drug on its own.
A Sibutramine Cardiovascular Outcomes Trial (SCOUT) was initiated as part of a postÂ market requirementÂ to look at cardiovascular safety of Sibutramine once Europe had approved the drug.Â and the FDA decided to pull the drug once they had read that report.
The data showed a 16 percent increase risk of serious heart events, including non-fatal strokes andÂ heart attacks. Many of these were incidents where the heart stopped beating and the patient had to be resuscitated.
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