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Darvon® and Darvocet® Linked to Death, Heart Attacks, and Arrhythmia
After 53 years on the market, the FDA and the companies who have manufactured and sold propoxyphene have learned that the drug can cause sudden death when used as prescribed.
Banned in the United Kingdom since 2005 and then the European Union in January 2009, an estimated 10 million patients have used these common painkillers.
On November 19, 2010 the FDA asked manufacturers of propoxyphene (Darvon®, Darvocet®) for a product recall.
“The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.” - FDA News Release, November 19, 2010.
Propoxyphene, Darvon® and Darvocet®
Propoxyphene is an opioid used to treat mild to moderate pain.
Approved by the FDA and available since 1957, propoxyphene is manufactured by Xanodyne Pharmaceuticals Inc., which markets the drug as Darvon® and Darvocet®.
The difference between the two painkillers is that while Darvon® is composed entirely of propoxyphene, Darvocet® combines propoxyphene and acetaminophen.
The Consumer Watchdog group Public Citizen first petitioned for a Darvon® recall in 1978. Thirty years later, the group filed a lawsuit against the FDA to cause action on a 2006 petition to remove the drug from the market.
Some of the other limitations of propoxyphene-containing medicines include:
· As weak painkillers, they may provide minimal benefits.
· The combination of propoxyphene with acetaminophen (Darvocet®) is sometimes said to be no more effective than acetaminophen on its own.
· The difference between the dose needed for treatment and a harmful dose is said to be too small, and increases the potential for overdose.
· As an opioid, it is sometimes addictive at times.
“The FDA is 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.” - FDA News Release, November 19, 2010.
Darvon®/Darvocet® Side-Effects
Severe and even tragically fatal responses to Darvon® and other pain medications containing propoxyphene have been reported, such as:
Death
Heart Attack
Heart Arrhythmia
Suicide
Overdose
If you or a loved one have been prescribed Darvon®, Darvocet® or another generic form of propoxyphene and have experienced any of these symptoms, please contact us immediately for a free consultation. Always make sure to talk with your physician before you stop taking any medications, including propoxyphene.
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