US govt wants painkiller Bextra off the market
The US government has asked pharmaceutical giant Pfizer to withdraw the painkiller Bextra from the market because it increases the risk of heart attack and stroke.
Regulators also want all other anti-inflammatory drugs in the same class to carry the strongest safety warning possible.
The Food and Drug Administration has been studying the safety of the so-called Cox-2 inhibitors since Merck voluntarily pulled Vioxx from the market in September after heart problems were reported in some users.
In addition to the prescription drugs, the FDA asked manufacturers of over-the-counter nonsteroidal anti-inflammatory drugs to revise their labels to include information about the risks of cardiovascular incident and gastrointestinal bleeding.
“Today’s actions protect and advance the health of the millions of Americans who rely on these drugs every day,” said Dr Steven Galson, acting director of FDA’s Centre for Drug Evaluation and Research.
In February, advisers to the FDA had recommended that people who depend on Celebrex, Bextra and Vioxx be allowed to continue to use them despite the health risks.
The panel said Vioxx posed the greatest risk and that Celebrex had the fewest side effects. It recommended that the prescription drugs carry strong warnings and that more study be done to get a better understanding about the drugs.
