Darvon and Darvocet Recall
Darvon and Darvocet have been recalled by the Food and Drug Administration due to their link with serious and potentially fatal heart rhythm abnormalities. The FDA also requested that the manufacturers of generic versions of these drugs—known as propoxyphene—withdraw their products as well.
Despite the FDA’s decision to recall Darvon and Darvocet, some have been critical of the agency’s speed in responding to safety concerns about the pain medications. According to the consumers group Public Citizen, data about the harmful cardiac effects of propoxyphene has existed for at least thirty years. Public Citizen unsuccessfully petitioned the FDA to recall Darvon, Darvocet and propoxyphene in 2006.
After Darvon and Darvocet were banned by health officials in Britain and the European Union in 2005 and 2009, the FDA convened an advisory panel to review the safety of these two drugs. In January of 2009, the panel voted that the FDA should withdraw Darvon and Darvocet from sale; however, the FDA decided to instead strengthen existing warnings for the drugs and to order a study of their side effects risk.
In November of 2010, the agency announced that data from this study showed that Darvon, Darvocet or propoxyphene could cause changes in the electrical activity of the heart, even when taken at normal doses. These electrical changes could produce abnormal heart rhythms, potentially leading to heart attack, stroke or sudden death. As a result of these findings, the FDA ordered a recall on Darvon and Darvocet.
If you or a loved one took Darvon, Darvocet or generic propoxyphene and suffered a heart attack, stroke, sudden death or other side effects, contact the attorneys at Hissey Kientz, LLP to learn more about your legal rights. You can reach us by calling toll-free at 1-866-275-4454, or by filling out the free case evaluation form on the right of this page.