A propoxyphene-containing painkiller has been named in a Darvocet class action lawsuit filed by a woman who claims it caused her to suffer a heart attack. Darvocet, as well as Darvon, were pulled from the market by Xanodyne Pharmaceuticals Inc. last month because of propoxypheneâ€™s association with serious and sometimes fatal heart rhythm problems.
Propoxyphene is an opiod painkiller that was already known to be highly addictive. In November, the US Food & Drug Administration (FDA) announced that Xanodyne Pharmaceuticals Inc. had agreed to pull the medications because of their association with serious <"http://www.yourlawyer.com/topics/overview/darvocet">side effects of Darvocet, namelyÂ heart rhythm problems. The agency said it was also asking the manufacturers of generic propoxyphene-containing products to remove those products from the market.
Darvocet plaintiff Linda Gallagher’s class action lawsuit was filed on December 3 in federal court in New Orleans, and is believed to be the first such suit filed since the drugs were pulled from the market. Her lawsuit, which was filed individually and on behalf of all others similarly situated, claims that Darvocet creates a significant risk of bodily harm, and that Xanodyne Pharmaceuticals failed to warn consumers and health care providers of these risks. The complaint further alleges that Xanodyne Pharmaceuticals violated the federal Food, Drug and Cosmetic Act. The proposed Darvocet class action lawsuit seeks compensatory damages, medical monitoring, court costs, interest and attorney’s fees.
Since 1978, the consumer group Public Citizen has petitioned the FDA twice to remove propoxyphene products like Darvon and Darvocet from the market. According to the group, evidence going back more than 30 years indicates that propoxyphene is not very effective, is toxic at doses not much higher than the recommended dose because a heart-toxic metabolite accumulates in the body, and is somewhat addictive. Public Citizen asserts that it has been linked to many thousands of US deaths since 1981, a large proportion of which were likely caused by cardiac toxicity, including the interruption of electrical conduction in the heart.
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 what it said were 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.
As Public Citizen points out, propoxyphene bans were announced in the United Kingdom almost six years ago, and in Europe, almost 1Â½ years ago. Since the United Kingdom ban was announced in 2005, approximately 120 million retail prescriptions have been filled in the US for propoxyphene-containing drugs. Public Citizen claims that due to FDA negligence, at least 1,000 to 2,000 or more people in the US have died from using propoxyphene during that time frame.