FDA Rejects Ban on Darvon, Darvocet

Although an FDA panel recommended a ban of the painkiller propoxyphene because of the risk of overdose, the FDA has chosen not to ban the drug (found in Darvon, Darvocet etc) but rather to make a few changes to the requirements of manufactures as to what's put on their labels. A public interest group had petitioned the FDA to enter into a phased withdrawal of propoxyphene. Their petition was denied.

Ultimately, the FDA decided that the benefits of propoxyphene, which first hit the US market in 1957, outweigh the risks.

Actions taken by the FDA regarding propoxyphene

--They will require manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products. (Manufacturers have 30 days to submit to the FDA these changes, or to provide a reason why they do not believe such changes are necessary.)

--They will require manufacturers to provide a medication guide to patients stressing the importance of using the drugs as directed.

-- They will require a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. Findings from this study, as well as other data, could lead to additional regulatory action.

From the FDA's Center for Drug Evaluation and Research

A word to doctors and patients from Dr Janet Woodcock, director, of the FDA Center for Drug Evaluation and Research:

“Physicians need to be aware of the risk of overdose when prescribing these drugs. They should carefully review patient histories and make appropriate treatment decisions based on the warnings and directions stated within the drug’s label."

“Prescribers and patients should be aware of propoxyphene’s potential risks when used at doses higher than those recommended. Therefore, the FDA is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain therapy.”

External links

You can read the FDA's press release HERE.

You can read a Q&A on propoxyphene by the FDA HERE