Bextra Withdrawn from Market

The painkiller Bextra was taken off the market Thursday, April 7, 2005, and the government wants similar prescription drugs to carry the strongest possible warnings about increased risk of heart attack and stroke among the millions of people who rely on them.

Pfizer Inc. suspended sales of Bextra in the United States and the European Union at the behest of the FDA and European regulators. Although the company cited a risk of serious, sometimes fatal, skin reactions to Bextra, the drug had already been associated with an increased risk of heart attack and stroke.

Bextra is one of a broad class of painkillers known as nonsteroidal anti-inflammatory drugs, or NSAIDS, and more particularly a particular type of NSAID known as a Cox-2 inhibitor. This class of very profitable drugs among arthritis sufferers until Vioxx, manufactured by Merck, was pulled off the market last fall. That withdrawal sparked questions about the safety of all Cox-2s.

Although Pfizer’s Celebrex currently remains on the market, the FDA announced it and all other prescription NSAIDS, must carry a black-box warning on its label that users may face an increased risk of cardiovascular side effects.

Pfizer has recommended that patients should stop taking Bextra and contact their physicians about appropriate treatment options.

Pfizer said it “respectfully disagrees” with the FDA that Bextra was too risky to continue selling and pledged further discussions with the agency about the possibility of returning it to the market.

In February, advisers to the FDA recommended that people who depend on Celebrex, Bextra, and Vioxx be allowed to continue to use them despite the health risks — although it only narrowly backed Bextra. The panel said Vioxx posed the greatest heart risk and that Celebrex seemed to have the fewest cardiovascular side effects among the Cox-2 drugs. It also recommended that the prescription drugs carry strong warnings and that more study be done to better understand the drugs’ risks.

If you have suffered a heart attack or stroke while taking Bextra, contact Fonvielle Lewis Foote & Messer immediately for a free consultation or fill out an online questionnaire.