The popular painkillers Darvocet and Darvon have been recalled by the FDA after it was determined that all medications containing the painkiller propxyphene pose an unreasonable risk of heart problems. On Friday, the FDA determined that new clinical data, which show that side effects of Darvocet include an increased risk of serious and sometimes fatal heart rhythm abnormalities, tipped the scales in favor of a recall, after determining that the risks associated with Darvocet and Darvon outweigh the benefits provided by the treatment.
Darvon was first introduced in 1957, containing propoxyphene to relieve mild to moderate post-surgical pain. Today it is most commonly prescribed as Darvocet, which combines the active ingredient in Darvon with acetaminophen, the active ingredient in Tylenol. Darvocet has become one of the most 25 most commonly prescribed medications, which has been prescribed to more than 22 million people.
The FDA indicates that it has been petitioned to recall Darvocet and Darvon from the market twice since 1978, but only now determined that the risks outweighed the benefits. One of those petitions came from Public Citizen, a consumer advocacy group, which called for a Darvocet and Darvon recall in 2006. A phased Darvon and Darvocet recall is already underway in the European Union.
“With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” said Dr. Gerald Dal Pan, director of the FDA’s Office of Surveillance and Epidemiology. “However, long-time users of the drug need to know that these changes to the heart’s electrical activity are not cumulative. Once the patient stops taking propoxyphene, the risk will go away.”
Dr. Sidney Wolfe of the Public Citizen’s Health Research Group said it was too little, too late, noting that Britain banned the drug six years ago.
“Due to FDA negligence, at least 1,000 to 2,000 or more people in the United States have died from using propoxyphene since the time the U.K. ban was announced,” Wolfe said in a statement.
“Our February 2006 petition to the FDA to ban the drug, following the U.K. ban announcement, did not even result in an FDA advisory committee hearing until we had sued the agency in 2008 to force them to respond to our petition.”
An FDA advisory committee split on whether to ban the drug in 2009. The European Medicines Agency pulled it from the market in June 2009.