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FDA pulls Darvon/Darvocet (propoxyphene) off market citing serious heart risk, advises those taking it to call doctor ASAP

  [ 16 votes ]   [ 1 Comment ] • November 23, 2010

On Friday, Nov 19, the U.S. Food & Drug Administration:

Asked that pain products containing the opioid propoxyphene be removed from the market. Propoxyphene is “an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxyphene is sold by prescription under various names both alone (e.g., the branded drug Darvon) or in combination with acetaminophen (e.g., Darvocet).” Propoxyphene is also found in generic versions. The drug was banned in the UK in 2005, and by the EU in 2009.

Issued safety alerts & warnings to physicians, pharmacists, and consumers, “advising health care professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy.” To view the FDA’s brief consumer advisory video, click HERE.

Explained in a press release that “We now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart…” by causing “significant changes to the electrical activity of the heart” that can seriously affect heart rhythms and even cause sudden death. The better news being that apparently “once patients stop taking propoxyphene, the risk will go away.”

Consumers with one of these drugs on hand might ask a phamacist for instructions on their disposal, as they are not included in the list of drugs the FDA suggests are OK to flush.

Note: For more information on the factors leading to the FDA decision regarding propoxyphene, and thoughts on the implications for pain patients, see Stewart B Leavitt's commentary at - "Propoxyphene Products Withdrawn in USA. Why?"

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Article Comments Post a Comment

Darvocet ban is dreadful for me
Posted by: sulis
Dec 1, 2010
I have fibromyalgia and osteoarthritis and take time-release acetaminophen 3 times a day. Because of medication allergies and bleeding problems, I cannot take any NSAIDS or any other pain pills except Darvocet. When I was hospitalized for surgery I was on morphine. In order to be admitted to inpatient physical rehab because the hospital situation had caused an acute fibro flare, I had to be switched to Darvocet. My pain level was an average of 8-9 on the Darvocet. Now if I face a similar situation I will have to go from morphine to acetaminophen. I can't imagine how I will be able to stand it. (I tried doing it after open heart surgery and had to have my husband bring me Darvocet because the hospital pharmacy didn't carry it.) I think it's interesting that this is the latest in a long history of trying to get Darvocet off the market. Before they were claiming it didn't do any good; now it has these terrible effects (unlike all the things they advertise on TV with their "fatal events"?). I have enough Darvocet to get me through periodontal surgery I've been dreading. Then I don't know what I'll do if I have a flare. Thanks, FDA for protecting me....
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