Darvocet Side Effects Pose Risk to Millions

Darvocet, a combination of propoxyphene and acetaminophen, was originally developed by Eli Lilly & Co., is now marketed by Xanodyne Pharmaceuticals. Propoxyphene, an opioid used to treat mild to moderate pain, was used by 10 million people in 2009, according to the FDA. Most of those patients received it in the form of Darvocet. In 2006, the Ralph Nader-associated consumer advocacy group Public Citizen asked the FDA to ban Darvocet, as well as Darvon (propoxyphene alone), saying they had been associated with serious Darvon and Darvocet side effects, including even the deaths of at least 2,110 people between 1981 and 1999. Dr. Sidney Wolfe, the group’s director, also asserted that propoxyphene was a relatively weak painkiller and posed an unacceptable toxic risk to the millions of patients prescribed it each year.



The suits started when propoxyphene (the generic name for Darvon) was cited in 589 overdose deaths in 23 U.S. cities. Public Citizen referred to propoxyphene as "the deadliest prescription drug in the United States," the group argued that propoxyphene figures into thousands of deaths and medical emergencies each year -- many of them accidental Darvocet overdoses. They continued their efforts with the 1989 Darvon-related death of former NFL great John Matuszak and “Goonies” star, which prompted the group to renew its demand for removal of the drug from the U.S. market.

The FDA action comes nearly six years after the drug was banned in the U.K., and nearly a year and a half after the European drug agency banned it. Ultimately, their studies found that even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, known side effects of Darvocet, including sudden death. Those suffering from the dangerous effects of Darvocet should consult with an experienced Darvocet lawyer as soon as possible.