On April 7, 2005, Pfizer Inc. – the world’s biggest drugmaker –pulled its troubled painkiller Bextra from U.S. and European pharmacies. The Food and Drug Administration found that the risks posed by the drug outweighed its benefits. In a statement, Pfizer said, “For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options”.
Bextra (valdecoxib) is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It is also a COX-2 inhibitor like Vioxx, Merck & Co.’s blockbuster arthritis drug that was voluntarily withdrawn from the market in September 2004 because of the drug’s link to increased heart attack risk. Like Vioxx, Bextra is used to reduce pain, inflammation, and stiffness caused by osteoarthritis and adult rheumatoid arthritis. Bextra is also used to treat painful menstruation.
In November 2004, Pfizer added a “black box” warning to the Bextra label to alert patients that Bextra triggers Stevens-Johnson syndrome – a life-threatening skin disorder that can lead to lesions and blisters causing intense pain and even death from infection.
In February 2005, an FDA advisory panel voted 17-13 to keep Bextra on the market. The FDA requested the painkiller’s removal despite that vote. The same panel recommended Vioxx be returned to the market, but that has not happened as yet.(FDA Drug Safety Report)
Requesting that Bextra be removed from the market was one of several changes the FDA called for to regulate non-steroidal anti-inflammatory drugs (NSAIDs). The same day, the FDA also requested that 19 other prescriptions carry a black box warning about the increased risk of strokes, heart attacks and gastrointestinal bleeding in millions of users of NSAIDs.
Other serious, possible side effects of Bextra include:
- Abdominal pain, tenderness, or discomfort
- Bloody, black, or tarry stools
- Nausea or heartburn
- Bloody vomit
- Unexplained weight gain
- Swelling or water retention
- Unusual fatigue or lethargy
- Yellowing of the skin or eyes
- Flu-like symptoms
- Unusual bruising or bleeding
The FDA’s request that the drug be removed from the market will undoubtedly be new awareness of the dangers associated with Bextra, and many users will want to know their rights and means of legal recourse. If you or a loved one has been injured by Bextra or any other dangerous drug, call the law offices of Hardison & Cochran. While financial restitution cannot compensate for the pain and suffering caused by dangerous drugs, victims can benefit from the knowledge that those who harmed others must pay for their actions. Please contact Hardison & Cochran, “the people’s law firm”.