Doctor in Sweden Warned FDA of Darvon/Darvocet Dangers in 1999

Last November, the Food & Drug Administration (FDA) decided to remove Darvon and Darvocet from the market.  But this was not the first time the idea had been proposed to the FDA.

In 1978 and again in 2006, Public Citizen, a U.S.-based advocacy group, asked the FDA to take Darvon and Darvocet (drug name propoxyphene) off the market.  The FDA denied both of these requests. 

In 2009, an advisory committee within the FDA reported that propoxyphene's risks outweighed its benefits.  The committee recommended that the FDA remove the drugs from the market, but the FDA refused, and instead required Xanodyne, the manufacturer of Darvon and Darvocet, to put a new warning on the drugs' box to inform patients and doctors of the risk of overdose associated with the drugs.

Although the drugs were on the market for over 50 years, evidence from as far back as 30 years ago indicated that propoxyphene was dangerous and was not effective for the treatment of pain.  This was further reinforced by studies published by Dr. Ulf Jonasson of Sweden, dating back to 1993.

Dr. Jonasson was able to obtain more conclusive study results than his American counterparts thanks to a national law requiring blood tests for every autopsy performed.  Here in the United States, county medical examiners rarely perform blood tests in autopsies, because they simply cannot afford to.  In his research, Dr. Jonasson found that of 1,600 autopsies confirming propoxyphene present in the bloodstream, all had died from heart conditions.

Dr. Jonasson informed the FDA in 1999 of his studies, but he claims that the FDA looked the other way and sided with Darvon and Darvocet's main manufacturer Eli Lilly.

The FDA finally banned Darvon and Darvocet, but some generic forms of the drugs are still available on the market.  In fact, some online pharmacies still allow patients to order the deadly drugs.  Dr. Jonasson predicts that the lawsuits filed on behalf of the victims of Darvon and Darvocet will be larger than those filed against Vioxx, which ended in a $4.85 billion settlement fund for the families of the victims who had heart attacks after taking the drug.