For the second time in a week, the FDA is talking painkillers. This time, it's Darvon and Darvocet, and they'll get a boxed warning of the risk of fatal overdose. In ordering the warning-formerly-known-as-the-black-box, FDA resisted calls for an outright ban on the products.
Here's the background: These drugs contain the active ingredient propoxyphene, which can be addictive and has been linked to patient deaths. Consumer advocates at Public Citizen petitioned the FDA to pull the drugs back in 2006; the meds had already been banned in the U.K. because of safety concerns. According to Public Citizen's petition, even small increases in dose could kick off adverse effects. Earlier this year, FDA convened an advisory committee to mull the issue, and it votes 14-12 to withdraw the meds.
The agency usually sides with its expert advisors, but not this time. Janet Woodcock, CDER director, said propoxyphene drugs are an acceptable choice for patients who have trouble with NSAIDs or strong narcotics--as long as they're used at recommended doses. The FDA also is requiring a new safety study to look at the drugs' cardiac effects. Public Citizen's Dr. Sidney Wolfe called this a "reckless decision," saying that the group is considering whether to lodge a formal appeal with FDA Commissioner Margaret Hamburg.
In going against the advisory committee's advice, the FDA may be giving new hope to makers of Vicodin, Percocet and their ilk. An expert panel last week recommended that these combination meds be banned because of the attendant risk of acetaminophen overdose.