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Steer clear of painkiller Darvon
Feb 3, 2009 5:02 PM

If you need a prescription medicine to relieve pain, you should steer clear of a medicine called propoxyphene. Although millions of prescriptions are written for this drug each year, expert advisors to the Food and Drug Administration recommended last Friday that it be taken off the market because it has been associated with deadly overdoses and suicides.

The drug, which for decades has been sold as a generic and under the brand name Darvon, is approved by the FDA for treating mild to moderate pain. It is also used in various generic and branded combination products, such as Darvocet, that contain acetaminophen.

More than 22 million prescriptions were written for propoxyphene products in 2007. The drug already has been banned in the United Kingdom, Switzerland, and Sweden. A citizen's petition filed by the watchdog group Public Citizen urging the FDA to ban propoxyphene products in the U.S. spurred the agency to convene a joint meeting of two of its advisory committees.

The committees voted 14-12 that drugs containing propoxyphene should be pulled from the market. It's not certain the FDA will follow this recommendation. The agency does not have to follow the advice of its advisory committees, but it often does.

The FDA's own analysis found that there have been more than 2,100 reports of serious problems—including suicide, overdose, and cardiac arrest—associated with propoxyphene use since it was first launched in 1957. This includes 1,452 deaths (98 deaths in 2006 and 2007). But because many of the cases involved multiple drugs, the agency said the data was insufficient to determine whether the deaths were due to propoxyphene alone.

The FDA also reviewed studies on the drug’s effectiveness and concluded that it is a weak pain reliever that provides little or no additional benefit beyond what can be obtained from acetaminophen.

CR's Take: Our Best Buy Drugs report on opioid pain medicines recommends against using products containing propoxyphene because of safety concerns. If you and your doctor decide you need an opioid pain drug, we instead recommend generic codeine with acetaminophen, generic morphine, generic oxycodone, or generic oxycodone with acetaminophen. To learn more about pain medicines, download our free report.

Steve Mitchell, associate editor, Best Buy Drugs

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