Need Counsel After Taking Darvocet?
On November 19, 2010, the Food and Drug Administration ("FDA") banned the sale of the painkillers Darvon and Darvocet in the United States after cardiac studies ordered in 2009 demonstrated they increased the risk of potentially fatal heart arrhythmias in healthy patients taking the medication in recommended doses. It has also ordered makers of the generic version of this drug's core compound, propoxyphene, to stop selling the drug.
Since 2001, our Darvocet lawyers at Sullivan & Brill, LLP have been helping New Yorkers receive just compensation for injuries sustained or loved ones lost due to dangerous drugs such as Darvon or Darvocet.
Darvon and Darvocet are opioid narcotics used to treat mild to moderate pain. Darvon is the brand name for propoxyphene and Darvocet is the brand name for propoxyphene mixed with acetaminophen. These painkillers were approved by the FDA in 1957, but have been plagued by safety concerns ever since.
In addition to the increased risk of heart arrhythmias, the drug has been linked to increased risk of suicide and accidental overdoses. This dangerous drug also has an unusually high death rate of 16 deaths for every 100,000 prescriptions. Public Citizen, a consumer advocacy group, petitioned the FDA to pull the drug from the market in 1978 and again in 2006, but the FDA declined, stating that the drug's benefits outweighed its risks.
Effects and Regulations
The introduction of safer drugs and additional studies of Darvon and Darvocet since 1978 have changed the cost benefit analysis. According to a statement issued by Dr. Sidney Wolfe of Public Citizen "Evidence going back more than 30 years indicates that propoxyphene is not very effective, is toxic at doses not much higher than the recommend dose," and is "somewhat addictive." The New York Times reported that "Propoxyphene has been shown to have very little effect on pain. Many studies showed no significant improvement by adding it to acetaminophen. Propoxyphene also has a narrow margin of safety between the recommended dose and a harmful dose or fatal overdose, according to the FDA review and other experts."
The drug was pulled from the British market by its regulatory agency in 2005 and by the European Union in 2009. In 2009, an FDA advisory committee voted 14-12 to ban marketing of the drug in the United States, but the FDA rejected the recommendation and ordered further studies of the drug. The results of these studies, conducted by the drug's manufacturer, Xanodyne Pharmaceuticals Inc., of Newport, Kentucky at the direction of the FDA, have now led the FDA to ban these dangerous drugs. However, the FDA's approach toward removal of dangerous drugs from the market, which allows a drug to continue to be sold while its risks are being studied, has likely led to 1000 to 2000 unnecessary deaths since 2005 when it was pulled from the UK market, estimates Dr. Sidney Wolfe of Public Citizen.
Doctors have been advised to immediately stop prescribing the drug and patients have been advised to continue taking it, but to immediately see their doctor to arrange for an alternative medication. The FDA estimates that 10 million prescriptions of Darvon and Darvocet where written in the United States in 2009 and SDI / Verispan indicates that 17.5 million prescriptions of the generic version were written in 2009. According to Dr. Farrar, chairman of the FDA advisory panel that recommended the drug's ban in 2009, and Dr. Wolfe, Extra Strength Tylenol may be the best alternative. Other alternatives, for patients in worse pain, include the opioids Tramadol and low-dose hydrocodone or oxycodone.