In November 2010, the FDA recommended pulling propoxyphene products after new studies found they can create abnormal heart rhythms even at normal doses. As a result one of the makers of the pain medication Darvon and Darvocet said they will stop marketing the prescription drugs.
Darvon (with active ingredient propoxyphene) was first marketed in 1957. Darvocet contains propoxyphene and acetaminophen. Both drugs are popular with more than 10 million prescriptions written for them in 2009. Safety concerns have been raised about propoxyphene for decades, but studies have only linked them to episodes in which a patient exceeded the recommended dose.
The FDA issued the following statements: “Using propoxyphene causes significant changes to the electrical activity of the heart. These changes are linked to potentially deadly abnormal heart rhythms. It is not possible to monitor for, or mitigate, the risk of a fatal cardiac arrhythmia that may occur within the recommended dosing range for propoxyphene.
The drug was kept on the market 2009 with the FDA issuing its toughest warning label “taking too much of the drug could be fatal,” despite a panel having voted to have it removed from the market.
The drugs were developed by the Eli Lilly & Company, who no longer makes them. Companies that continue to produce them are generic drug companies like Xanodyne, who agreed to remove the drugs from the market. The FDA asked other companies to do the same.
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