FDA says prescription drug prescribed to millions may cause serious or fatal heart rhythm abnormalities
Proffitt & Cox is reviewing cases for potential representation in which a person has suffered heart rhythm problems and serious adverse effects after taking the prescription painkillers Darvon, Darvocet or the generic equivalent, propoxyphene.
The manufacturer of the controversial prescription pain medication Darvon and Darvocet has agreed to withdraw the medication from the U.S. market, the U.S. Food and Drug Administration recently announced. Read the press release.
Xanodyne Pharmaceuticals Inc. makes the brand version of the medication propoxyphene. The FDA also has asked generic manufacturers of propoxyphene-containing products to voluntarily remove their products as well, based on Xanodyne's decision. The medical problems caused by Darvon and Darvocet are potentially serious or even fatal heart rhythm abnormalities, according to the FDA. The FDA has concluded, based on clinical and epidemiological data, that the risks of the medication outweigh the benefits.
The FDA has told physicians to stop prescribing propoxyphene to their patients, and recommends that patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy. Propoxyphene is an opioid used to treat mild to moderate pain. The FDA estimates that 10 million prescriptions for the medications were written in 2009 alone.
The drug was first approved by the FDA in 1957. It has been sold by prescription under various names, including as a stand-alone medication (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet). The FDA reported that it has received two requests to remove propoxyphene from the market since 1978.
The FDA previously had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug.
In 2006, Public Citizen, a consumer advocacy group, petitioned the FDA to ban Darvocet, Darvon and their generic equivalents due to safety concerns.
In January 2009, the FDA held an advisory committee meeting to address the efficacy and safety of propoxyphene. After considering the data submitted with the original drug applications for propoxyphene, as well as subsequent medical literature and postmarketing safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug's cardiac effects would be relevant in weighing its risks and benefits.
In June 2009, the European Medicines Agency (EMEA) recommended that the marketing authorizations for propoxyphene be withdrawn across the European Union. A phased withdrawal of propoxyphene is underway.
In July 2009, the FDA decided to permit continued marketing, 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. In addition, the agency required Xanodyne to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart.
On November 19, 2010, the FDA announced that data from the study showed 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, including sudden death. The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.
Contact Proffitt & Cox
If you or a loved one took Darvon or Darvocet pain medication, or a generic equivalent containing propoxyphene, and suffered abnormal heart rhythms or other serious adverse effects, contact the Darvocet lawyers at Proffitt & Cox, LLP, Attorneys at Law, by calling (803) 834-7097 in Columbia or toll free nationwide (877) 276-0533. You can also complete our contact form to schedule an initial consultation. We are conveniently located in the BB&T building at 8910 Two Notch Road, near I-77 and I-20 in Northeast Columbia.