Bextra safety update from Pfizer

Bextra is a pain relief drug often prescribed to arthritis patients and belongs to the family of COX-2 drugs that also include Celebrex and now recalled Vioxx. Bextra is made by Pfizer and has attracted a lot of attention since the recall of Vioxx and reports of adverse side effects in a few studies. (Related article: Bextra safety doubted in two studies)

Bextra, along with Celebrex, is under review by the FDA and other drug agencies worldwide. There is speculation that Bextra may be recalled.

In its review for the fiscal year 2004, Bextra maker Pfizer today provided the following update on cardiovascular safety of Bextra:

"We have announced that, in two trials in high-risk surgery known as coronary artery bypass graft (CABG), an increase in cardiovascular events was observed in the first two-arm trial, in which patients received Bextra in combination with parecoxib (an intravenous form of Bextra) compared to placebo. However, in a second three-arm trial, this same increase in cardiovascular events was seen only in the Bextra/parecoxib combination arm compared to placebo and not in the arm treating these patients with Bextra alone. (Related article: Pfizer warned by FDA on misleading Bextra ads)

In studies in general surgery, Bextra in combination with parecoxib showed no increased risk of thromboembolic events.

Bextra is not approved for use in surgical settings in the U.S. We will be conducting clinical studies to further assess the cardiovascular profile of Bextra in arthritis patients. Recently, working with the FDA, we changed the prescribing information for Bextra to include this information about the CABG studies as well as to provide other information about the cardiovascular safety of Bextra. The revision to Bextra’s prescribing information also added a black-box warning relating to serious skin reactions."

Recommended article: FDA recommends limited use of Bextra after Vioxx recall