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Federal regulators requested the removal of popular painkillers Darvon and Darvocet from the U.S. market on Friday. Propoxyphene (generic name), puts patients at risk of potentially serious or fatal heart rhythm problems, according to the U.S. Food and Drug Administration (FDA).

Doctors should stop prescribing the drugs, both which are made by Xanodyne Pharmaceuticals. Patients currently taking these drugs should consult their medical doctor before discontinuing use, recommends the FDA. All generic drugs that contain propoxyphene will also be withdrawn.

The opioid, first approved by the FDA in 1957 to treat mild to moderate pain, is sold under a variety of names, including Darvon, which is the drug alone, and Darvocet, which is the drug combined with acetaminophen.

The decision to remove the drug came after the FDA reviewed a new trial study that looked at the drug’s impact on heart rhythms.

The agency has received two requests to remove this drug from the market, since 1978, but concluded the benefits for pain relief at recommended dosages, outweighed safety risks until now.

For more information, please refer to the FDA press release and view a video about the action.


  1. Gravatar for CECELIA


  2. Gravatar for Terence Mix

    The FDA’s decision to order Darvon and other propoxyphene-containing products removed from the market on November 19, 2010, comes 5 YEARS after the pain reliever had been banned in Great Britain and a YEAR AND A HALF after it was withdrawn by all other members of the European Union. While other countries were taking strong regulatory steps to protect their citizens, the FDA’s reaction had been to simply increase the warnings on its risks. Darvon and its sister drugs have had a long history of drug addiction, suicide and cardiac problems since first entering the market in 1957. My question is this – why should it take 53 years to determine that a drug should not be on the market?

    This history is not unique. On October 8, 2010, the FDA announced that Abbott Laboratories would be withdrawing Meridia from the American market, 9 months after the weight-loss drug was removed by the European Union. Earlier, the FDA had only strengthened the warning on the drug’s labeling, cautioning its users about the risk of heart attacks and strokes. On September 23, 2010, the FDA decided to allow Avandia to remain on the market, while the European Medicines Agency decided to pull the plug on the drug in Europe. These decisions are somewhat reminiscent of the history involving the drug, Cylert, which was withdrawn by the FDA in 2005 because it was causing severe liver damage to children taking it for ADHD – eight years after it was withdrawn by Great Britain.

    This pattern of increasing warnings while other countries are removing drugs that do not belong on the market is only a small sample of why our FDA and its oversight of drugs is no longer the gold standard of the world. Meanwhile, thousands of Americans are dying unnecessarily. As many as 230,000 per year die in the United States as a result of an adverse reaction to prescription and/or nonprescription drugs – a number that can be cut in half.

    Changes need to be made and they need to happen now. And it has got to start by eliminating the insanity of drug companies conducting their own premarket studies rather than an impartial entity, such as the National Institutes of Health. For everyone who is in agreement with taking some action, I would urge you to go to the website, and sign my petition to Congress demanding a change. Only if the citizens of this country speak in a strong and unified voice will we catch the attention of Congress and impress upon it the need for such a change.

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