FDA Stops Sales of Darvon…after More Than 50 Years

Sunday, November 21, 2010
More than fifty years after it hit the market, and five years after the United Kingdom banned it, the painkiller Darvon is being pulled off the American market at the request of the Food and Drug Administration (FDA). The drug and a related brand, Darvocet, have stirred controversy for years, but the final straw was a medical study showing that the active ingredient, propoxyphene, can cause deadly heart rhythms. Propoxyphene was first approved by the FDA in 1957.
The FDA decision affects not only the drug maker, Xanodyne Pharmaceuticals, but also manufacturers of generic painkillers that use propoxyphene.
Britain banned Darvon in 2005, and the European Union followed suit in 2009, following numerous suicides and accidental overdoses associated with the drug.
FDA officials said a recent study found Darvon interferes with the electrical activity of the heart, causing irregular heart rhythms that can lead to death.
About 10 million Americans take propoxyphene painkillers. Experts warned users not to immediately stop taking the drugs, but instead work with doctors to switch to a new method of pain control.
-Noel Brinkerhoff
FDA Pulls Darvon Painkiller Due to Safety Risks (by Matthew Perrone, Associated Press)
Darvon, Darvocet Banned (by Daniel J. DeNoon, WebMD)


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