Valdecoxib cardiac safety

Valdecoxib cardiac safety. On April 7, 2005 the FDA announced that it has asked Pfizer, Inc. to withdraw Bextra® (Valdecoxib) from the market "because the overall risk versus benefit profile for the drug is unfavorable."

Potential for increased risk of cardiovascular events
Gastrointestinal bleeding
Serious skin reactions, some resulting in death.

FDA INFORMATION

To read the FDA's announcement withdrawing Bextra®.
Click here to read the FDA questions and answers about strengthened warnings on Bextra® boxes.
To report any unexpected adverse or serious events associated with the use of Bextra® contact the FDA MedWatch program on the internet or at 1-800-FDA-1088

bextra site map

Bextra® is a non-steroidal anti-inflammatory drug (NSAIDs), known as a COX-2 selective agent. It is prescribed for inflammation and pain from arthritis or menstrual cramping. Other drugs in this class include Celebrex® and Vioxx®. Bextra® and Celebrex® are both marketed by Pharmacia Corporation and Pfizer and Vioxx® is manufactured by Merck. Doctors switched patients from Vioxx® to Bextra® when Merck voluntarily removed it from the market due studies showing an increased risk for heart attack and stroke.

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