FDA Painkillers

FDA asks Pfizer to take painkiller Bextra off market

The government has asked 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 inhibiters since Merck voluntarily pulled Vioxx from the market last year after heart problems were reported in some users. Advisers to the FDA have recommended that people who depend on Celebrex, Bextra and Vioxx be allowed to continue to use them despite the health risks.

The FDA also is asking 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.