bextra

by Nathan Wei, MD, FACP, FACR

Nathan Wei is a board-certified rheumatologist and author of the Second Opinion Arthritis Treatment Kit. It's available exclusively at this website... not available in stores.

Click here: Second Opinion Arthritis Treatment Kit

The US Food and Drug Administration announced it will be adding warnings alerting of the potential risks associated with valdecoxib (Bextra, Pfizer). Bextra was officially removed by the FDA in 2004.

The new warning labels will appear on product boxes contraindicating the use of valdecoxib in patients undergoing coronary artery bypass graft (CABG) surgery. And previous warnings of the risk of potentially fatal skin reactions will be strengthened.

Valdecoxib is a cyclo-oxygenase-2 selective nonsteroidal anti-inflammatory drug (NSAID) that is indicated in the US for the treatment of osteoarthritis, rheumatoid arthritis, and menstrual pain. According to the FDA, patients taking valdecoxib have reported serious, potentially life-threatening skin reactions, including Steven-Johnson Syndrome and toxic epidermal necrolysis. Skin reactions are reportedly most likely to occur in the first 2 weeks of treatment but can happen any time during therapy. In a few cases, reactions have resulted in death.

The new warning advises clinicians that valdecoxib should be discontinued at the first appearance of a skin rash, mucosal lesions, or any other sign of allergic reactions. The new label also states that valdecoxib contains sulfa and patients with a history of allergic reactions to sulfa may be at a greater risk.

The FDA says that as of last month, it had received reports of 87 cases of severe skin reactions linked to valdecoxib. Of these, 36 hospitalizations were reported, including 4 deaths. Twenty of the cases involved patients with a known allergy to sulfa. "Other COX-2 inhibitors and traditional NSAIDs such as naproxen and ibuprofen also have a risk for these rare, serious skin reactions, but the reported rate of these serious side effects appears to be greater for valdecoxib than for other COX-2 agents," the FDA said in a statement.

Pfizer first warned doctors in October that valdecoxib is associated with an increase in MI and stroke in CABG patients. In November, the company submitted the results of a new study to the FDA.

The Pfizer study, which included more than 1500 patients treated after CABG, showed an increased cardiovascular risk in patients receiving valdecoxib compared with placebo. Observed risks included thromboembolic events such as myocardial infarction, cerebrovascular events, deep vein thrombosis, and pulmonary embolism.

The study confirms the risk of intravenous administration (about 2% of patients had such an adverse event). It also shows that oral valdecoxib is associated with a somewhat lower risk (about 1% of patients) immediately following CABG surgery. In the placebo group, approximately 0.5% of patients had a cardiovascular event. The FDA emphasized that "valdecoxib is not approved for use in the treatment of postoperative pain of any type," and it specifically contraindicates the use of valdecoxib for the treatment of pain following CABG.

The FDA is urging healthcare providers and patients to report adverse-event information by telephone: 1-800-FDA-1088, by fax: 1-800-FDA-0178, or online: http://www.fda.gov/medwatch/index.html. A special advisory committee reviewing all COX-2 inhibitors is scheduled to meet in February.