FDA recommends Cox-2 drugs remain available

PAINKILLERS linked to deaths from heart disease should stay on the market but with stringent warnings and restricted use, a US Food and Drug Administration panel recommended last week.

The first of a new class of painkillers known as Cox-2 inhibitors were approved in the US in 1999. Doctors welcomed them as an alternative to non-steroidal anti-inflammatory painkillers, which can cause ulcers and intestinal bleeding.However, one of these drugs, Vioxx, was withdrawn last September after research suggested the drug increases the risk of heart disease. Since 1999 Vioxx is believed to have caused between 88,000 and 140,000 extra cases of serious heart disease in the US alone. Two related drugs, Celebrex and Bextra, are still on the market.Last week, the FDA panel concluded that all Cox-2 inhibitors increase the risk of cardiovascular problems and should not be used in anyone at risk of heart attacks. However, they said the drugs should not be banned because the benefits outweigh the risk for some patients.The FDA says it will act on these recommendations in a few weeks, but says that Vioxx may not return to market immediately.The FDA has been criticised for failing to recognise the risks earlier. As a result, the FDA has set up a new independent oversight board to monitor drug safety.(Source: New Scientist magazine, February 2005, page 4)