Darvon, Darvocet Dangers Prompted Action by Pharmacists Years Before Recall

The Darvocet and Darvon recall has the approval of some pharmacists. According to a report in the News-Leader out of Missouri, some pharmacists there said they stopped stocking Darvon and Darvocet years ago because of safety concerns. It’s too bad, really, that the US Food & Drug Administration (FDA) didn’t act as quickly.

In November, the FDA asked the makers of propoxyphene products to pull them from the market because of their association with serious Darvon and <"http://www.yourlawyer.com/topics/overview/darvocet">Darvocet side effects including potentially fatal heart rhythm problems. The FDA finally acted on propoxyphene after a study conducted by Xanodyne Pharmaceuticals, the maker of Darvon and Darvocet, found it could cause irregular heartbeat. This condition, called QT prolongation, lengthens the time between the Q wave and T waves, which are two of five electrical impulses that measure the regularity of a heartbeat. There are no symptoms of this condition, but it can lead to a potentially lethal rapid heartbeat called ventricular tachycardia.

Bob Campbell, director of the pharmacy at Skaggs Community Health Center, told the News-Leader that his pharmacy hasn’t stocked the drugs since 2007.

“The reports have been out there for a long time that it hasn’t been real effective in treating pain and there were side effects,” Campbell said. “We just felt it was time to pull it off our formulary.”

Lynn Morris, president and owner Family Pharmacy, told the News-Leader that her chain quit recommending Darvon and Darvocet for nursing home patients because of its side effects.

Propoxyphene is an opiod painkiller that was first sold as Darvon in 1957. Darvocet is a combination drug made with propoxyphene and acetaminophen. In 2009, 10 million prescriptions were written for propoxyphene products.

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. Public Citizen has petitioned the FDA twice since 1978 seeking the removal of Propoxyphene products like Darvon and Darvocet 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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