Thousands of individuals who were taking Darvocet and Darvon painkillers for pain management have found themselves suffering from dangerous cardiovascular problems. Patients harmed by the adverse side effects of the drugs have begun filing lawsuits against the manufacturer, Xanodyne Pharmaceuticals.
While concerns about Darvon and Darvocet surfaced publically after the FDA request for propoxyphene-based drugs to be withdrawn from the market in November 2010, controversy over the drug has been ongoing. Patients that have been harmed by cardiac toxicity contained in Darvon and Darvocet medications are filing lawsuits to obtain compensation for damages incurred.
The concern over the defective drugs lies with the fact that Propoxyphene (the active ingredient in Darvon and Darvocet) is an opiate. In addition to its addictive properties and the high risk of overdose, the drug has now been shown to cause fatal heart rhythm irregularities. Propoxyphene was banned in the United Kingdom six years ago and in the European Union a year and a half ago. However, the FDA has been blamed by critics for having a slow response to address claims that the drugs pose a serious health risk.
For more than 30 years, consumer groups like Public Citizen have been calling for propoxyphene-based drugs including Darvon and Darvocet to be recalled. The organization has linked the drug to thousands of deaths in the United States since 1981.
In January 2009, the U.S. Food and Drug Administration advisory panel voted 14-12 to recommend that Darvon, Darvocet and propoxyphene generics be removed from the market. However, instead of banning the drugs, the agency settled for requiring the drugs be sold with a boxed warning. The FDA has been criticized that the warning label was incomplete because it did not mention cardiac toxicity as a negative side effect of the drug.
The FDA continued to ask Xanodyne to conduct a study into the effect of Darvon and Darvocet on the heart’s electrical activity. All the meanwhile, patients continued to take the drug. When the results of the safety study were complete, almost a year later, the FDA immediately asked for the drugs to withdrawn from market.
As one of the 25 most commonly prescribed medication in the U.S., more than 22 million people have taken Darvocet at some point in their lives, according to estimates.
Now, more than 30 years after health concerns emerged about propoxyphene, lawsuits allege that Xanodyne was negligent in manufacturing and distributing medications that were known to have harmful effects on patients. Thousands of patients filing lawsuits have experienced near-fatal cardiac arrhythmias while taking the painkiller. Many of these individuals now require life-long heart monitoring as well as medication and other treatments to support their cardiac function.
Legal Help for Victims of Darvon & Darvocet Side Effects
If you or someone you love has been hospitalized by Darvon or Darvocet side effects, please contact us immediately to discuss your case with a Darvon Recall Lawyer at our firm.