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Darvon, Darvocet pulled from market due to potentially fatal heart problems

Consumer Reports News: November 19, 2010 06:40 PM

The Food and Drug Administration said today that the painkiller  propoxyphene is being withdrawn from the market because it has been linked to a potentially deadly heart-rhythm abnormality, even when taken at recommended doses. Some 10 million people took the drug last year, both as stand alone pills, such as Darvon, and in products such as Darvocet, which combine it with acetaminophen.

If you’re currently taking a medication containing propoxyphene, don’t abruptly stop it, since that can trigger withdrawal symptoms such as nausea and trembling. But do  contact your doctor, so you can safely and gradually switch to a different medication.

"We concluded that the pain relief benefit of propoxyphene no longer outweighed the heart risks," John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, saidat a press conference this morning.

Last year, two advisory committees recommended that the FDA remove the drug from the market. The FDA noted that propoxyphene had been associated with more than 2,100 reports of serious problems—including suicide, overdose, cardiac arrest, and death—since it was first launched in 1957. While the agency went against that advice and allowed propoxyphene to remain on the market, it also directed the manufacturer, Xanodyne, to conduct the study that found the heart-rhythm dangers.

Our Best Buy Drugs report on opioid pain medicines has long recommended against using products containing propoxyphene because of safety concerns. If you and your doctor decide you need an opioid pain drug, we recommend generic codeine with acetaminophen, generic morphine, generic oxycodone, or generic oxycodone with acetaminophen.

Steve Mitchell, associate editor, Consumer Reports Health Best Buy Drugs


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