Propoxyphene, better known by long-used brand names Darvon and Darvocet, may stay on the market, but must carry a new, stronger version of the Food and Drug Administration's most serious warnings to consumers and physicians. Products containing propoxyphene, an opiate used to treat mild to moderate pain, will now carry more stringent warnings about the dangers of taking more than the recommended dose, the FDA announced today.
The agency also announced that it has ordered studies on the risk of dangerous cardiac side effects associated with Darvon and related pain medications, as well as on the extent of their use in the elderly -- a population for which propoxyphene is considered to be problematic and less effective than newer, safer drugs.
Propoxyphene's dangers most recently came to light in February 2006, when the group Public Citizen petitioned the FDA to remove the drug from the market. The FDA said today that while it may take further action against the pain drug after studies have been completed, it would allow its continued sale, with the strengthened "black-box" warnings.
The decision came as the agency also considers the advice of one of its own advisory panels, which recently recommended banning further sale of several other widely prescribed opiate pain medications -- those that include acetaminophen, among them Vicodin and Percocet.
Propoxyphene was found to have been associated with roughly 2,110 deaths in the United States between 1981 and 1999, and during the same period was found in autopsies to have been implicated in 5.6% of drug-related deaths in the U.S. Public Citizen had sued the FDA in June of last year for failing to rule on its 2006 petition, prompting the FDA to act this week.
-- Melissa Healy