FDA Panel Votes to Keep Painkillers on the Market

MARCH 01, 2005

The popular painkillers Vioxx, Celebrex, and Bextra will in all likelihood be available for patients who need them. An FDA advisory panel recently voted to keep all 3 painkillers, known as cyclooxygenase- 2 inhibitors, on the market. The decision came after a 3-day meeting to discuss their safety. Because the panel agreed that all 3 drugs posed cardiovascular risks, they said that these drugs must be used under strict warnings and scrutinized supervision.

The panel was in favor of black box warning labels, the highest level of warning at the FDA. The labels will alert patients that these drugs can help but cannot be taken lightly. The panel voted 17 to 15 to keep Merck & Co Inc's Vioxx (rofecoxib) on the market. In September 2004, Merck voluntarily withdrew its arthritis and acute pain medication from the market. The company's decision was based on new, 3-year clinical data from a prospective, randomized, placebo-controlled trial, the APPROVe (Adenomatous Polyp Prevention on Vioxx) trial. The study showed an increased risk for confirmed cardiovascular events (ie, heart attack, stroke) beginning after 18 months of treatment in the patients taking Vioxx, compared with those taking placebo. Merck spokesman Christopher Loder said that the company will discuss with FDA officials any actions it needs to take in order to resume selling the drug.

Since Vioxx's withdrawal, studies have associated Pfizer's Celebrex (celecoxib) and Bextra (valdecoxib) with the same risks. The panel voted 31-1 to keep Celebrex on the market and 17-13 for Bextra (with 2 panel members abstaining). Analysts had projected that the heart attack and stroke risk associated with Celebrex might lead the panel to recommend a black box warning. Bextra already contains a black box warning.

Pfizer will work with FDA officials on Celebrex's new label. The company also plans long-term studies about the heart safety of both drugs, according to Pfizer spokeswoman Susan Bro.