Quoted from http://www.bloomberg.com/news/2010-11-19/darvon-darvocet-will-be-withdrawn-in-u-s-over-heart-risks-fda-says.html?
Darvon, Darvocet Will Be Withdrawn in U.S. Over Heart Risks, FDA Says
By Molly Peterson - Nov 19, 2010 11:50 AM ET
Xanodyne Pharmaceuticals Inc. is pulling the prescription painkillers Darvon and Darvocet from the U.S. market, the Food and Drug Administration said.
The FDA asked the Newport, Kentucky-based company to withdraw the drugs because of heart risks, the agency said today in a statement. The FDA has requested that makers of generic versions of the active ingredient take them off the market.
That constituent -- propoxyphene, an opioid used to treat mild to moderate pain -- was approved by the FDA in 1957. New clinical data show the drug increases the risk of potentially fatal heart-rhythm abnormalities, the FDA said. Closely held Xanodyne sells propoxyphene as Darvon, and in combination with acetaminophen as Darvocet.
The data “suggested that the heart risk of propoxyphene could apply to all users, not just those who took excessive doses or those with medical conditions,” such as reduced kidney function, John Jenkins, director of the FDA’s Office of New Drugs, said today on a conference call.
About 10 million people in the U.S. received prescriptions for propoxyphene-containing products in 2009, said Gerald Dal Pan, director of the FDA’s Office of Surveillance and Epidemiology, on the conference call.
“For the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” he said in the statement.
Users of the drug “need to know that these changes to the heart’s electrical activity are not cumulative,” he said. “Once patients stop taking propoxyphene, the risk will go away.”