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Darvon, Darvocet Patients Should Discuss Alternatives with Their Doctors

Nov 29, 2010 | Parker Waichman LLP

The recent decision to pull the painkillers Darvon and Darvocet from the market because of their association with dangerous, and even fatal heart rhythm problems has caused consternation among people who relied on Darvon and Darvocet to manage chronic pain. But according to a recent article in The Wall Street Journal, there are alternatives to these potentially dangerous medications.

Darvon and Darvocet, which were on the market for more than 50 years, are made with propoxyphene, an opiod painkiller. It was already known that propoxyphene could be highly addictive. But earlier this month, the US Food & Drug Administration (FDA) announced that Xanodyne Pharmaceuticals Inc. had agreed to pull the medications after a study linked them to serious and possibly fatal heart rhythm problems. The agency said it was also asking the manufacturers of generic propoxyphene-containing products to remove those products from the market. 

The FDA was widely criticized for taking too long to act on Darvon and Darvocet. Since 1978, the agency received two requests from the group Public Citizen to ban propoxyphene. The United Kingdom banned propoxyphene in 2005 and the entire European Union followed suit in January of 2009. In January 2009, an FDA advisory panel narrowly voted 14-12 to recommend that the FDA remove Darvon and similar products from the market.

Rather than heed the advice of its advisory panel, the FDA decided to permit continued marketing of Darvon, Darvocet and other propoxyphene products, but required that a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of a fatal overdose. While the new warning did not include mention of heart rhythm problems, the agency required Xanodyne Pharmaceuticals, the company that markets Darvon and Darvocet, to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart. The results of that study finally prompted the FDA to request the medications be removed from the market.

Some patients, however, are now faced with finding alternatives to manage their chronic pain. Many of these patients have a problem tolerating other painkillers, according to The Wall Street Journal. Such patients are being advised to discuss their needs with their doctors.

Some possible alternatives to Darvon and Darvocet include Tylenol, with or without codeine, or non-steroidal anti-inflammatory drugs such as ibuprofen. Patients who cannot take those drugs because of issues with GI bleeding might find relief from tramadol, for moderately severe pain, and tapentadol (sold under the brand name Nucynta), for moderate to severe acute pain. In some instances, doctors may recommend more powerful painkillers such as oxycodone or hydrocodone-containing drugs, which are intended for serious pain, the Journal said.

As the Journal points out, all of these drugs carry their own risks and side effects. Patients will need to make sure they discuss these issues with their doctors.

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