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Label for sibutramine to include new contraindication for individuals with CVD
Wednesday, February 17 2010 | Comments
What's This?
The Food and Drug Administration said the label for the obesity drug sibutramine hydrochloride, which is marketed by Abbott under the brand name Meridia, will now include a contraindication for use among patients with a history of cardiovascular disease (CVD) because of the increased risk of myocardial infarction (MI) and stroke.This move strengthens the drug's label, which previously only contained warnings against the use of sibutramine in patients with CVD.
The addition of the contraindication follows the regulatory agency's review of additional data from the SCOUT study, which Abbott was conducting as part of a postapproval commitment between the company and the European Medicines Agency.
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