FDA Requests Withdrawal of Darvon, Darvocet from U.S. Market

The FDA is requesting that manufacturers of the painkiller propoxyphene pull the drug from the market because of concerns over cardiotoxicity. (Propoxyphene is marketed alone as Darvon and combined with acetaminophen as Darvocet.)

The agency's request is based on data showing that, even when taken at therapeutic doses, the drug can lead to potentially dangerous changes in the heart's electrical activity, including prolonged PR and QT intervals and widened QRS complex.

The FDA advises clinicians to stop prescribing propoxyphene and to ask current users to discontinue the drug.