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Adverse Drug Reaction
EMEA to review celecoxib studies' results
January 25th, 2005
The European Medicines Agency (EMEA) has been informed by Pfizer of a clinical study that shows an increased risk of major fatal or nonfatal cardiovascular events (ie, acute myocardial infarction and stroke) in patients taking celecoxib compared to patients given placebo. Celecoxib is a member of the class of medicines called COX-2 inhibitors. This study, conducted by the U.S. National Cancer Institute (NCI), the Adenoma Prevention with Celecoxib trial (ACP), involved 2400 patients with an average duration of 33 months' treatment, taking 400 mg or 800 mg celecoxib per day. The increased risk appears to depend on dosage, with a 2.5-fold increase with...
Source: Life Science Weekly (2005-01-25)
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