Propoxyphene Recall

November 19, 2010 | Category: Recalls

FDA Drug Safety Communication: FDA recommends against the continued use of propoxyphene

Safety Announcement

[11-19-2010] The U.S. Food and Drug Administration (FDA) is recommending against continued prescribing and use of the pain reliever propoxyphene because new data show that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. FDA has requested that companies voluntarily withdraw propoxyphene from the United States market.

Propoxyphene is an opioid pain reliever used to treat mild to moderate pain. It is sold under various names as a single-ingredient product (e.g., Darvon) and as part of a combination product with acetaminophen (e.g., Darvocet).

FDA’s recommendation is based on all available data including data from a new study that evaluated the effects that increasing doses of propoxyphene have on the heart (see Data Summary below). 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 and prolonged QT interval. These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms. FDA has concluded that the safety risks of propoxyphene outweigh its benefits for pain relief at recommended doses.

In July 2009, FDA announced an ongoing safety review of propoxyphene, which included evaluating its potential effects on the heart.

Source: US Food and Drug Administration

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