Popular Painkiller Darvon Banned By FDA


Friday, November 19th 2010, 4:28 pm
By: News On 6


Associated Press

UNDATED -- A popular painkiller has been pulled off the market. The Food and Drug Administration are stopping the sale of Darvon and Darvocet and generic versions of the drugs because health workers say it can cause dangerous heart rhythms.

Darvon was first approved in the 1950s but was banned in Britain several years ago because of suicides and accidental overdoses.

FDA officials said they decided to take action based on a recent study showing Darvon interferes with the electrical activity of the heart, causing irregular heart rhythms that can be fatal. Xanodyne conducted the study last year at the government's request.

"This last study, the cardiac study, was sort of the final piece of the puzzle that told us what the complete picture was," said Dr. Gerald Dal Pan, director of FDA's office of surveillance and epidemiology.

Dal Pan said patients should continue taking the medication until their doctor prescribes a replacement therapy. Other commonly-prescribed drugs in the same class are oxycodone and codeine.

But public safety advocates said the agency should have acted much sooner to pull a drug with limited benefits and a long history of safety problems.

"The FDA's deadly delay in this case starkly illustrates how one of the most important public health concepts, the precautionary principle, was embraced by the UK and Europe, but was for too long recklessly rejected by the FDA," said Dr. Sidney Wolfe, of the consumer watchdog group Public Citizen.

Wolfe estimated that at least 1,000 to 2,000 U.S. patients died from taking Darvon since the U.K. banned the product in January 2005.