December 15, 2006: FDA Approves New Use for Celebrex
The U.S. Food and Drug Administration (FDA) approved Celebrex for the relief of signs and symptoms related to Juvenile Rheumatoid Arthritis (JRA) in patients two years of age and older. JRA is an autoimmune disease that affects approximately 30,000 to 60,000 children in the United States. JRA symptoms range from joint swelling, pain, and decreased range of motion to permanent disability in severe, uncontrolled cases. Click here to read the FDA news release.
On December 17th, 2004 the National Institutes of Health (NIH) announced that it has suspended the use of COX-2 inhibitor celecoxib (Celebrex) for all participants in a large colorectal cancer prevention clinical trial conducted by the National Cancer Institute (NCI). The study, called the Adenoma Prevention with Celecoxib (APC) trial, was stopped because analysis by an independent Data Safety and Monitoring Board (DSMB) showed a 2.5-fold increased risk of major fatal and non-fatal cardiovascular events for participants taking the drug compared to those on a placebo.
In the APC clinical trial, patients taking 400 mg. of Celebrex twice daily had a 3.4 times greater risk of cardiovascular events compared to placebo. For patients in the trial taking 200 mg. of Celebrex twice daily, the risk was 2.5 times greater. The average duration of treatment in the trial was 33 months. However, a similar ongoing study comparing Celebrex 400 mg. once a day versus placebo, in patients followed for a similar period of time, has not shown increased risk.
Both the manufacturer of Celebrex (Pfizer) and the FDA are currently evaluating the data from these studies.
Also on December 17, the FDA asked Pfizer, Inc. to voluntarily suspend direct-to-consumer advertising on Celebrex during the time the FDA is obtaining and evaluating the new and conflicting scientific data on adverse events associated with the drug. FDA also requested Pfizer change the information provided to physicians to reflect the recommendations FDA made encouraging physicians to consider alternative therapies as they evaluate their individual patient needs. Pfizer agreed to suspend its Celebrex promotion and to craft appropriate detailing to physicians that reflects the uncertainty of scientific data currently available.
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This includes material from the U.S. Food and Drug Administration, and the National Institutes of Health.
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