Alerts
Propoxyphene Products (Darvon, Darvocet) - Withdrawn From the Markets
November 22, 2010
FDA has asked manufacturers to withdraw all propoxyphene-containing products (Darvon, Darvocet, generics) from the market. New data show propoxyphene can cause significant cardiac toxicity including prolonged PR interval, widened QRS complex, and prolonged QT interval, increasing the risk for serious abnormal heart rhythms. The safety risks of propoxyphene outweigh any benefit for pain relief.
On January 30, two FDA advisory committees had voted in support of removing propoxyphene from the market. The risks associated with propoxyphene appeared to outweigh any potential benefits. Evidence from Europe indicated that propoxyphene may be more lethal than other pain medication in overdose situations. Public Citizen, a public interest group, and the FDA’s advisory council recommended a phased withdrawal of propoxyphene products. However, on July 8, the FDA decided not to remove propoxyphene from the market due to differences in prescribing practices between the US and Europe and the benefits of propoxyphene for pain relief.
In July 2009, FDA required changes to the current propoxyphene boxed warning to include an emphasis on the risk of overdose when using products containing propoxyphene. In addition, FDA required propoxyphene product manufacturers to produce a medication guide for pharmacists to provide to patients with each new propoxyphene prescription and refill.
FDA recommended a study to evaluate the effects of high dose propoxyphene on the heart and began evaluating the prescribing practices and safety profile of propoxyphene in the elderly in conjunction with the Centers for Medicare and Medicaid Services (CMS) and the Veterans Heath Authority. Data from the study prompted the market withdrawal of propoxyphene products.
FDA recommends clinicians stop prescribing and dispensing propoxyphene-containing products and work to switch patients to alternative medications. Patients should dispose of their medications according to Federal Drug Disposal Guidelines http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm226353.htm by mixing any left-over drug with used coffee grounds or kitty litter and place in a sealable bag or container and dispose in the garbage.
Additional information can be found through the following links:
- FDA Information
- MedWatch Alert (November 19, 2010):
http://www.fda.gov/Drugs/DrugSafety/ucm234338.htm - Drug Safety Podcast (November 21, 2010):
http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm234455.htm - Press Release (November 19, 2010):
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234350.htm - Press Release (July 7, 2009):
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170769.htm - Propoxyphene Questions and Answers (November 19, 2010):
http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm234337.htm - Drug Safety Information for Patients & Providers (November 19, 2010):
http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm233800.htm - Epidemiologic Review of Propoxyphene Safety (November 19, 2010):
http://www.fda.gov/downloads/Drugs/ DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM234383.pdf - Multiple-Ascending Dose Study Review (October 21, 2010):
http://www.fda.gov/downloads/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/UCM234330.pdf - ASHP Information
- News Article (11/2010):
http://www.ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=3442 - Position Statement (12/2008):
http://www.ashp.org/DocLibrary/Advocacy/Propoxyphene.aspx
Updated
November 22, 2010; November 19, 2010; July 9, 2009; February 20, 2009; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.
