Personal Injury Law

Popular Painkillers Darvon/Darvocet Yanked From Pharmacies Due to Heart Risk

By Jamie G. Goldstein

Propoxyphene (PPX), a prescription painkiller sold under the names Darvon and Darvocet, has been linked to heart complications and removed from the market. Darvon is pure propoxyphene while Darvocet combines propoxyphene with acetaminophen. Propoxyphene was first placed on the market in 1957 and by the 1970s had become one of the most popular prescription drugs.

The U.S. Food and Drug Administration (FDA) decided in late last November to pull Darvon and Darvocet off the market after both drugs were linked with reports of heart problems and the agency concluded in a memorandum that 'the benefits of PPX no longer outweighed its risks.' The drugs, produced by Xanodyne Pharmaceuticals, were found to cause cardiac damage or fatality even when taken in the recommended doses. The FDA's action was prompted by the results of a clinical trial showing that the drug altered the electrical activity of the heart, which can cause rhythmic disturbances. The results of the study showed the dangerous risk of heart abnormalities far outweighed the benefit of the drug in reducing pain. In 2009, propoxyphene was prescribed to around 10 million Americans for pain relief.

The drug was completely banned in the UK in 2005 and in Europe in 2009. Why was the United States the last to act? The ban hardly comes to a surprise to some, especially the Public Citizen's Health Research Group who advocated pulling PPX from pharmacies years ago. They estimate that around 1,000-2,000 Americans have died from taking PPX. These numbers are drawn from Florida statistics that show around 400 deaths occurring from the drug over a 4 year span.

In 2009 an FDA panel voted 14-12 against continued marketing of PPX. As a result, the FDA included a new warning label including the risk of fatality. A study on the effects of recommended doses of 600 mg and 900 mg on the heart showed a severe risk of arrhythmia and a greater risk of death than similar pain killers like hydrocodone and tramadol. Other alternatives to taking Darvon or Darvocet include anti-inflammatory drugs such as Advil, Aleve, Cataflam, and Celebrex. Experts say that once one stops taking PPX, the risk of heart problems will disappear. However, many may have to be slowly weaned off of the drug or have it replaced with another opiate for pain management. Still others may not yet be aware of the ban.

Full post as published by Chicago Personal Injury Lawyer on January 07, 2011 (boomark / email).