Published: March 2011

Dextropropoxyphene: FDA advice highlights cardiac risks

Prescriber Update 32(1): 1
March 2011

Recent action by the FDA to remove dextropropoxyphene from the market in the US has further highlighted the risks associated with the use of medicines in which it is contained.

Following a review of data, the FDA concluded that, even when used at recommended doses, dextropropoxyphene can cause significant changes to the electrical activity of the heart. These changes, which can be seen on ECG, increase the risk of serious abnormal heart rhythms that have been linked to serious adverse effects including sudden death.

Given this finding the FDA concluded that the risks associated with dextropropoxyphene were greater than the benefits of using this medicine. Consequently the FDA recommended that these medicines be removed from the market in the US.1

Following a comprehensive risk:benefit review, dextropropoxyphene was withdrawn from New Zealand in August 2010; however Medsafe understands that several patients are still being prescribed this medicine. Prescribers may wish to consider this new information about cardiac risks before continuing treatment with dextropropoxyphene as an unapproved medicine.

Summary and key messages:

  • Dextropropoxyphene is no longer approved for use in New Zealand.
  • No new patients should be prescribed dextropropoxyphene-containing medicines.
  • Prescribers should be familiar with the requirements associated with prescribing unapproved medicines, e.g. named patient supply, informed consent.
  • Prescribers should re-assess the balance of risks and benefits in each patient continuing treatment as an unapproved medicine given the new US data. Further information about the withdrawal of these medicines in New Zealand is available at:
  1. FDA (2010). Xanodyne agrees to withdraw propoxyphene from the U.S. market. Accessed 16/2/11 from: