Millions of Americans learned about the health problems associated with the popular drug Darvocet following its recall in November of 2010, but others who knew about the risks say the recall was 30 years overdue.
The Food and Drug Administration (FDA) requested the withdrawal of all propoxyphene-based painkillers, including Darvon and Darvocet (manufactured by Xanodyne Pharmaceuticals), from the marketplace. The company voluntarily complied.
Consumer groups, including Public Citizen, however, said the November recall was long overdue. The same drugs were banned in the United Kingdom six years ago for their proven cardiac toxicity, and in the entire European Union almost two years ago.
Public Citizen petitioned the FDA twice in the past 30 years to join European countries and ban Darvon and Darvocet, for its cardiac toxicity, overdoses risks and addictive properties caused by the ingredient propoxyphene.
The FDA, however, waited on issuing a warning of the drugs, as it increased in popularity in the United States. Darvocet is one of the 25 most-prescribed drugs in the United States, with estimates suggesting it has been given to more than 22 million people at some point in their lives.
In 2009, and FDA panel voted 14-12 to ask for the withdrawal of propoxyphene-based drugs, including Darvocet and Darvon. Instead of initiating a recall, the FDA settled with a boxed warning on the medications, which ironically did not mention the possibility of cardiac toxicity.
The FDA decided it did not have enough evidence of the drugs’ damaging effects on the heart, despite the findings of researchers in the United Kingdom and Europe, including one study in dogs published 31 years ago by researchers at Eli Lilly, the company that originally developed propoxyphene. That study said, clearly, “Cardiac conduction depression may be a factor in some of the [human] cardiac toxicities associated with propoxyphene overdose.”
The FDA asked Xanodyne to conduct a safety research study because to provide evidence of the drugs’ damaging effect on the heart. When that study showed cardiac toxicity as a result of the medications, the FDA immediately called for a recall.
But throughout the slow process, propoxyphene-based medications were being prescribed to hundreds of thousands of patients who may have already suffered adverse health effects.
Along with patients filing lawsuits against Xanodyne Pharmaceuticals for their fatal heart rhythm irregularities, Public Citizen is calling for a congressional investigation of the manner in which the FDA handled the propoxyphene controversy.
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