The painkiller propoxyphene was developed in 1957 by Eli Lilly & Co. This opiate derivative, with similar properties to codeine, was used in Darvon and Darvocet. The drug is said to be 20% as powerful as morphine and was intended for treatment of mild to moderate pain. When combined with acetaminophen, the drug was sold under the brand name “Darvocet”, one of the most prescribed drugs in the United States.

Darvon, Darvocet, and their generic equivalents were officially taken off the market on November 19, 2010. Over 20 million prescriptions were written in 2007 for proxyphene-based drugs, and approximately 600 million since 1957. Xanodyne Pharmaceuticals distributes Darvon and Darvocet in North America while Qualitest and Vintage Pharmaceuticals manufacture and distribute their generic counterparts.

Overdoses pose an inherent risk to patients, as users can often build up tolerance to propoxyphene, which can result in serious injury or death if combined with other drugs or alcohol. The consumer protection group, Public Citizen, petitioned the FDA to withdraw the drug from the market due to these factors.

Public Citizen’s initial request was denied in 1978, but they filed a second request in 2006 citing claims that the drug was linked to cardiac toxicity and numerous other health complications. Both the United Kingdom and European Union banned the drug after independent research showed the prolonged use interrupted the heart’s electrical activity.

An independent advisory panel made up of medical experts voted 14-12 for the medications removal from the market. The decision was overruled by FDA regulators, who instead, requested that Xanodyne research claims that the drugs caused harm to the heart. The research study showed conclusive evidence linking cardiac toxicity to use of propoxyphene based drugs. The FDA immediately requested Xanodyne to issue a recall of the painkillers.

Hence, it took 30 years and 600 million prescriptions for the FDA to request a ban; only after Public Citizen repeatedly questioned the drug and early research done by Eli Lily showed cardiac toxicity. Public Citizen is now calling on congress to investigate the FDA’s actions.

We Offer Legal Help to 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 Maryland Darvon Recall Lawyer at Greenberg and Bederman.