Darvon and Darvocet

Xanodyne Pharmaceuticals, Inc. announced the withdrawal of medications Darvon and Darvocet from the U.S. market. These drugs were shown to put patients at risk for serious and sometimes fatal heart rhythm abnormalities, according to a U.S. Food and Drug Administration study. The FDA study found through their clinical data that Darvon and Darvocet, which goes by the generic name propoxphene, is too dangerous to warrant further use.

The FDA has since notified the remaining manufacturers of propoxphene-containnig products of the decision made by Xanodyne to remove its medications from the market. The FDA has further requested that the generic manufacturers remove their propoxphene as well. Health care professionals are being advised to discontinue prescribing these products to their patients. Patients currently taking the drug should immediately contact their health care professional and discuss changing to a safer pain medication therapy.

As an opiod, propoxyphene has been used to treat mild to moderate pain after being approved by the FDA in 1957. Propoxyphene is sold both as an isolated drug (Darvon) and in a combination with acetaminophen (Darvocet). Concerns about the safety of propoxyphene arose in 1978, and later in 2009. The FDA created a committee to analyze the data available to determine the legitimacy of these concerns. In July of 2009 a warning was added to the drug articulating the dangers of an overdose of the product. The FDA further required Xanodyne to conduct a new study to investigate the unanswered questions that emerged about the potential negative effects of propoxyphene on the heart.

The study revealed that even at recommended dose levels, propoxyphene causes significant alterations to the electrical activity of the heart. It is this effect that has been seen to increase the chances of serious side-effects including heart failure and sudden death. The abnormal heart rhythms stimulated by propoxyphene, and the potentially devastating effects thereof, is forcing the companies that manufactured it to abandon future production.

Our firm is pursuing cases which involve sudden death or hospitalization with an abnormal heart rhythm while taking Darvon or Darvocet.