News Flash

Propoxyphene Removed from U.S. Market

The FDA notified healthcare professionals that Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene, an opioid pain reliever used to treat mild to moderate pain, from the U.S. market. The FDA requested that the drug be removed due to new data showing that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. The FDA concluded that the safety risks of propoxyphene outweigh its benefits for pain relief. The FDA requested that the generic manufacturers of propoxyphene-containing products remove their products as well.

The FDA's recommendation is based on all available data, including data from a new study that evaluated the effects of increasing doses of propoxyphene on the heart. The results of the new study showed that when propoxyphene was taken at therapeutic doses, there were significant changes to the electrical activity of the heart:

• Prolonged PR interval
• Widened QRS complex
• Prolonged QT interval

These changes can increase the risk for serious abnormal heart rhythms.

The FDA recommends that healthcare professionals:

• Stop prescribing and dispensing propoxyphene-containing products to patients
• Contact patients currently taking propoxyphene-containing products and ask them to discontinue the drug
• Inform patients of the risks associated with propoxyphene
• Discuss alternative pain management strategies

Patients should dispose of unused propoxyphene in household trash by following the recommendations outlined in the Federal Drug Disposal Guidelines. Prodoxyphene is sold as Darvon, Darvocet, and generics.

Read the MedWatch safety alert, which includes links to the Drug Safety Communication, News Release, and supporting documents.