On November 19, 2010, Xanodyne, the manufacturer of propoxyphene, which is more commonly known under the brand names Darvon and Darvocet, agreed to issue a recall of all Darvon and Darvocet drugs in the United States. This most recent FDA recall for Darvon/Darvocet was issued following a previous recall in February 2009. Darvon is a painkiller which was first introduced in 1957, and contains propoxyphene to relieve mild to moderate post-surgical pain.
The recall was issued because of more than 3,000 serious reports of Darvon and Darvocet problems identified, with most involving heart problems, suicides, addiction and overdoses. In addition, the FDA indicated that Darvocet and Darvon provides little to no more pain relief than taking acetaminophen alone.
“The FDA is pleased by Xanodyne’s decision to voluntarily remove its products from the U.S. market,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (“CDER”). “These new heart data significantly alter propoxyphene’s risk-benefit profile. The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.”
In January 2009, the FDA assembled an advisory committee meeting to address the health concerns and public safety surrounding propoxyphene. Upon the review of data and additional medical literature and post marketing safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products. In June 2009, the European Medicines Agency (“EMEA”) requested that all marketing and advertising for propoxyphene cease across the European Union. To date, advertising and marketing of propoxyphene is under a removal process. In July 2009, the FDA required that a new warning be added to the drug label which informed patients and health care professionals to the risk of a fatal overdose. The FDA also required Xanodyne to conduct a new safety study to answer prior unanswerable questions about the harmful effects of propoxyphene.
Data from the study conducted by Xanodyne showed that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart, which can be seen on an electrocardiogram (“ECG”), can increase the risk for serious abnormal heart rhythms that have been linked to serious effects, including sudden death. The study also showed small changes in the health status of the patient, such as dehydration, or decreased kidney function.
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“With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology, CDER. However, long-time users of the drug need to know that these changes to the heart’s electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away.
How to take action
If you or a loved one has taken Darvon or Darvocet recently contact a law firm handling these issues immediately. For fifteen years, Bernstein Liebhard LLP (“BL”) has exclusively represented injured consumers in complex individual and class action lawsuits throughout the United States. The Firm has twenty-five lawyers, and trained paralegals with offices in New York. We have recovered over $3 billion for our clients. The Firm and its lawyers have been extensively recognized as national leaders in our bar for injured victims. For example, The National Law Journal has named BL, for nine consecutive years, as one of the top plaintiffs’ litigation firms in the country””an achievement that only one other law firm has obtained. The respected legal guide, Martindale-Hubbell, has also given BL it’s highest ratings for legal ability (A) and ethical standards (V).