Bextra

valdecoxib

Bextra (valdecoxib) is prescribed to relieve the pain, inflammation, and stiffness of osteoarthritis and adult rheumatoid arthritis. Since its introduction, Bextra has been associated with serious skin and hypersensitivity reactions. These reactions occurred in patients with and without a history of allergy to sulfa-containing products. Although these adverse events are rare, some of the patients required hospitalization. The most serious of these is a rare skin condition known as Stevens-Johnson syndrome. Stevens-Johnson syndrome is a form of allergic reaction usually caused by certain types of drugs. Symptoms usually begin as a blistering of the lips and mouth that spreads to the throat, tongue, and other parts of the body. The blisters sometimes become so extensive that they are fatal. Jean Farrell, founder of the non-profit Stevens-Johnson Foundation, said that within weeks of Bextra hitting the market she had an increase in calls about the disease, claiming to have had “six cases of SJS reported to us” within three weeks of the availability of Bextra.

Following the withdrawal of Vioxx, Merck and Co.’s similar anti-inflammatory medication, Pfizer announced the findings of two small clinical trials that showed heart bypass surgery patients taking Bextra also had an increased risk of heart attack and stroke. Based on these reports, the FDA approved labeling changes that include a warning that Bextra can increase heart problems for those undergoing heart bypass surgery.

Bextra’s labeling has also been updated to warn against serious skin reactions. The labeling also states that the drug is contraindicated in patients who are allergic to sulfonamides. Since these reactions can be life threatening, Bextra should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.

If you experience any of the following side effects while taking Bextra, you should call your doctor right away. They may indicate the presence of severe cardiovascular, renal, or skin effects that can threaten your life:

• Swelling around the ankles, feet, lower legs, hands, or around the eyes
• Unusual weight gain
• Black stool
• Vomiting, especially with the presence of blood in the vomit
• Skin rash or blisters

Source:

Reuters Health , “Another Arthritis Drug Shows Risks,” 11/01/04.