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.
The Darvocet and Darvon recall was announced Friday afternoon by the FDA and Xanodyne Pharmaceuticals, Inc., which manufactures the popular pain medications. All generic Darvocet and generic Darvon versions of the medication have also been recalled.
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 25 most commonly prescribed medications, which has been prescribed to more than 22 million people.
An FDA advisory panel first recommended that the agency recall Darvocet and Darvon in February 2009, after determining that the minimal pain relief benefits provided by the drugs do not outweigh the substantial risk of overdose and suicide. However, the FDA decided in July 2009 to allow the medications to remain on the market with a new “black box” warning about Darvon and Darvocet side effects, which is the most stringent warning label possible under federal regulations.
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.
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.”
The FDA said in its announcement that it will advise health care professionals to stop prescribing Darvon and Darvocet to patients and said patients currently taking the drugs should contact their health care professional as soon as possible to discuss switching to another pain medication.