FDA Advisory Panel to Decide Fate of Bextra and COX-2 Drugs

Beginning February 16, 2005, the FDA advisory panel met for three days to debate the future of COX-2 drugs such as Bextra. At issue is drug safety for COX-2 inhibitor painkiller drugs such as Bextra, Celebrex, and Vioxx.

Studies have emerged over the past year which cast doubt about the safety of Bextra and other COX-2 drugs. After Merck withdrew Vioxx from the market in September 2004, studies have emerged showing Pfizer's Bextra to be equally dangerous. In January 2005, a University of Pennsylvania meta-analysis study analyzing the findings of two Bextra drug trials estimated that Bextra triples the risk of heart attack and stroke in certain patients. Dr. Garret FitzGerald, lead researcher at the University of Pennsylvania, said the studies let him to conclude the entire class of COX-2 drugs poses a risk to patients.

In February 2005, WellPoint Inc., the nation's largest provider of health benefits, examined 7,232 patient records of people taking Vioxx, Celebrex, and Bextra, and 629,245 records for patients not taking a COX-2 drug. Vioxx and Celebrex were found to increase patients' risk of heart attack and stroke by 20%, and Bextra increased the risk by 50%.

Bextra has already been given a black box warning and the FDA issued a Talk Paper, as well as Questions and Answers About Bextra in December 2004. The black box warning on the Bextra label warns of potential for serious skin reactions, such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme.

The combined warnings are serious enough that Kaiser Permanente, a California based HMO, hospital, and health clinic network, stopped prescribing Bextra in February 2005 for at least six months, or until the FDA and/or manufacturer Pfizer can prove Bextra is safe. Kaiser is the nation's largest not-for-profit healthcare provider, serving 8.5 million people in nine states.

Read more on our Bextra Information Page >>