Bextra is a prescription medication approved by the FDA in November 2001 to treat the severe pain associated with osteoarthritis, rheumatoid arthritis, and primary dysmenorrhea (painful menstrual cramping). Over 23 million Americans suffer from some form of arthritis. Because there is no cure for arthritis, pain medications like Bextra are available to treat the pain associated with this disease. Bextra is manufactured by pharmaceutical company Pfizer and has come under significant scrutiny since a similar drug was pulled from the market.
COX-2 selective medicines were developed to treat pain without causing the significant gastrointestinal side effects that are associated with non-selective pain medications such as naproxen and ibuprofen. Controversy over the safety of COX-2 selective pain medications began when a drug similar to Bextra, called Vioxx (from Merck), was recalled on September 30, 2004 after studies concluded that taking Vioxx for a period of eighteen months or more doubled a patients risk of suffering from heart attack or stroke.
Since the Vioxx recall, the cardiovascular safety other COX-2 selective drugs has come into question. There have been no substantiated reports documented in medical journals or confirmed by independent researchers that have concluded that Bextra use poses an increased risk of cardiovascular problems.
Bextra cardiovascular safety was covered in an American Heart Association meeting in early November 2004. Studies reported at this conference indicated an increased risk in heart complications for patients taking Bextra who undergo cardiac bypass surgery. In response to these reports, and the general scrutiny surrounding COX-2 inhibitors, Pfizer announced in mid October 2004 that plans are underway to study the long term cardiovascular effects of Bextra.
The FDA and Pfizer are negotiating the inclusion of a black box warning (the FDA's highest alert category) on all Bextra labeling to disclose information about the risks of developing serious skin diseases caused by taking Bextra. The FDA acknowledged twenty cases of serious skin diseases caused by Bextra at the time of its approval.
Bextra is known to cause a rare but deadly skin disease called Stevens-Johnson syndrome as well as toxic epidermal necrolysis. Severe allergic reactions (including anaphylactic shock) have also been associated with Bextra use. Common side effects of taking Bextra include- but are not limited to- indigestion, headache, stomach pain, nausea and diarrhea. It is still unclear whether taking Bextra poses any threat to cardiovascular health.
