FDA Advised to Pull Darvocet Off Market
The pain medications Darvon and Darvocet should be pulled off the market, according to a recommendation approved on a 14-12 vote by a panel of medical experts assembled by the Food and Drug Administration (FDA).
CNN reported Jan. 30 that the panel said the risks of death from cardiac problems that are associated with the drugs — both of which contain the active ingredient propoxyphene — outweighed their benefits. However, the FDA is responsible for the final decision.
The drugs have been linked to heart problems and also carry the risk of addiction. They also can cause death when used in combination with alcohol or other drugs.
The FDA will also consider the possibility of ordering post-market studies or changing the drugs’ labels, said Sharon Hertz, deputy director of FDA’s anesthesia, analgesia and rheumatology products division.
Darvon, developed by Eli Lilly & Co., has been sold for 50 years in the U.S. Lilly also created Darvocet, which contains both propoxyphene and acetaminophen.
The panel was prompted to meet after a public-advocacy organization, Public Citizen, petitioned and then sued the FDA to remove the products.
“All drugs have risks,” said Sidney Wolfe, director of Public Citizen’s health research group. “If they don’t have benefits they need to come off the market.” Wolfe presented the panel with data showing 503 deaths in 2007 in which propoxyphene was a contributing factor.