FDA Drug Safety Podcast: Withdrawal of Products that Contain Propoxyphene
On November 19, 2010 the Food and Drug Administration issued a drug safety communication about the withdrawal of products that contain propoxyphene.
I am Yolanda Fultz-Morris from F-D-A’s Center for Drug Evaluation and Research.
FDA has concluded that the safety risk of products that contain propoxyphene outweigh their limited benefits for pain relief at recommended doses. The Agency will ask companies to withdraw these products from the United States market.
Propoxyphene is an opioid pain medication used to relieve mild to moderate pain; it has been marketed in approved drugs since 1957. Propoxyphene is sold under various names as a single-ingredient product such as Darvon and as part of a combination product with acetaminophen, such as Darvocet.
FDA’s recommendation to withdraw propoxyphene is based on new data that shows when propoxyphene is taken at approved doses, there are significant changes to the electrical activity of the heart. These changes can increase the risk for serious abnormal heart rhythms.
FDA recommends that consumers taking products that contain propoxyphene should:
- Talk to their healthcare professional about discontinuing propoxyphene and switching to alternative pain medicines.
- Contact their healthcare professional right away if they experience an abnormal heart rate or rhythm or other symptoms including dizziness, lightheadedness, fainting or heart palpitations.
- Dispose of unused propoxyphene by following recommendations outlined in the Federal Drug Disposal Guidelines.
FDA recommends that healthcare professionals:
- Stop prescribing and dispensing propoxyphene-containing products.
- 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 other than propoxyphene with patients.
- Be aware of the possible risk of cardiac conduction abnormalities in patients taking propoxyphene and assess patients for these events if they show signs or symptoms of arrhythmia.
FDA urges healthcare providers and patients to report any adverse events or side effects that may be associated with the use of propoxyphene-containing products to FDA’s MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at W-W-W dot F-D-A dot GOV slash M-E-D-W-A-T-C-H.
Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash D-R-U-G-S.
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