Washington- Friday, November 20, 2010, The Food and Drug Administration pulled the popular painkillers Darvocet and Darvon from the U.S. marketplace due to data showing that these drugs can cause the risk of serious heart rhythm abnormalities.
The FDA states that in 2009, ten million people were using these brand name drugs and their generic counterpart propoxyphene, which is an opioid used to treat mild to moderate pain. Most of them were receiving the drug in combination with acetaminophen, a compound known by the Darvocet trade name.
The FDA also states that the painkillers can easily be replaced with other more updated painkillers that have no indications of serious side effects.
U.S. regulators first approved Darvon (propoxyphene) in 1957, and there has been much controversy over the dangerous side effects of this drug.
Sidney Wolfe of Public Citizen’s Health Research Group blasted the FDA’s action as being too late and called for congressional hearings regarding why this action has taken so long.
According to Wolfe, at least 1,000 people in the U.S. have died from using propoxyphene since the 2005 ban in Britain. Britain in 2005, and the European Union in June 2009, both effectively pulled propoxyphene from the market because of health concerns.
The FDA has urged doctors to immediately stop prescribing these drugs, however, advising patients at the same time to continue taking propoxyphene until their doctor finds an alternative medication.
“We concluded that the pain relief benefit no longer outweighed the health risks,” said John Jenkins, director of new drugs in FDA’s Center for Drug Evaluation and Research, in a telephone press conference with reporters.
Many doctors have been prescribing propoxyphene because it is so well known, but better alternative painkillers are on the market, which will accommodate those needing pain management.
“We have many better options,” said Mehul Desai, director of pain medicine at George Washington University Hospital, in Washington. “It tends to be a pretty poor pain reliever.” A few of those options include oxycodone, morphine and Nucynta.
Friday’s announcement continues a tougher FDA line on drug safety. It is the second time in six weeks the agency pushed to have a drug removed from the market.
Xanodyne Pharmaceuticals Inc., of Newport, Kentucky, which makes Darvon and Darvocet stated they would comply with the FDA’s request to withdraw the drug. Generic makers of propoxyphene are expected to follow suit.
For more information regarding this recall visit: http://www.fda.gov/Drugs/default.htm.
Source: Los Angeles Times