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Propoxyphene – Labeling Changes to Prevent Overdose

July 9, 2009

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 an effort to decrease the risk of propoxyphene overdose in the US, the FDA is requiring changes to the current propoxyphene boxed warning to include an emphasis on the risk of overdose when using products containing propoxyphene. In addition, the FDA is requiring propoxyphene product manufacturers to produce a medication guide for pharmacists to provide to patients with each new propoxyphene prescription and refill.

The FDA is initiating a study to evaluate the effects of high dose propoxyphene on the heart and will begin 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.

The FDA encourages prescribers to be aware of the risk of potentially fatal overdose in patients taking propoxyphene. Careful review of the patient profile before prescribing or dispensing these drugs is suggested. Patients should be informed of the potential risk of propoxyphene if not used as recommended. Propoxyphene overdose is particularly difficult to treat as propoxyphene does not respond to naloxone.

Additional information can be found through the following links:

Please contact the Drug Information Service at 581-2073 if you need any further details.

Updated
July 9, 2009; February 20, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.