Darvon, Darvocet Recall Delay May Have Killed Thousands

How many Darvon and Darvocet deaths may have occurred while the US Food & Drug Administration (FDA) waited to pull these and other dangerous propoxyphene-based drugs from the market? It’s probably impossible to know for sure, but according to the consumer advocacy group Public Citizen, deaths linked to Darvon or <"http://www.yourlawyer.com/topics/overview/darvocet">Darvocet side effects including heart rhythm problems could number in the thousands.

Propoxyphene is an opiod painkiller that was first sold as Darvon in 1957. Darvocet is a combination drug made with propoxyphene and acetaminophen. In November, the FDA announced that Xanodyne Pharmaceuticals Inc. had agreed to pull Darvon and Darvocet from the market after a study linked propoxyphene to serious and sometimes fatal heart rhythm problems. The agency was also asking makers of generic propoxyphene medications to pull those as well.

While it was on the market, millions of Americans took propoxyphene products like Darvon and Darvocet. According to Public Citizen, despite its widespread use, propoxyphene is not very effective, is toxic at doses not much higher than the recommend dose because a heart-toxic metabolite accumulates in the body, and is somewhat addictive. It has been linked to many thousands of US deaths since 1981, a large proportion of which were likely caused by cardiac toxicity, including the interruption of electrical conduction in the heart, the group said.

Public Citizen has petitioned the FDA twice since 1978 seeking Darvon and Darvocet recall from the market. Propoxyphene bans were announced in the United Kingdom almost six years ago, and in Europe, almost 1½ years ago. In January 2009, an FDA advisory panel even recommended that propoxyphene be banned in the US, but the FDA waited to act.

According to Public Citizen, at least 1,000 to 2,000 or more people in the US have died from using propoxyphene since the UK ban was announced. The best forensic data, the kind relied upon in those countries for the UK and European bans, come from Florida where, because of routine drug testing required by the state medical examiner as part of many autopsies, deaths are categorized as being “caused” by certain drugs if the levels found are to be above a certain level. From 2005 through 2009, in Florida alone, 395 deaths were “caused” by propoxyphene.

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