The FDA Acts 32 Years Later

Last Friday, the Food and Drug Administration announced that the drug propoxyphene (sold under the brand names Darvon and Darvocet) is going to be taken off the market.

Propoxyphene was a generic pain medication with similar effects as Extra Strength Tylenol, but with serious side-effects on the heart that has led to a “staggering” number of deaths during its 53-year use.
A petition to ban propoxyphene first came to the FDA in 1978 from the advocacy group Health Research Group of Public Citizen, led by Dr. Sidney M. Wolfe and again in 2006 after Britain banned the drug in 2005.
In 2009, medical examiners in Florida reported a large amount of deaths linked to propoxyphene, leading the European Union to ban it. And finally, in January 2009, the FDA followed suit. Dr. Wolfe responded to this victory, saying, “I would have praised them if they had done this six years ago, but it’s hard to praise them when there have been 120 million more prescriptions filled since 2005 and conservatively 1,000 to 2,000 more deaths. It’s inexcusable.”
This frightening oversight–one that kept the FDA blinded for 32 years–should come as a shock, but we have seen again and again the FDA’s fallibility when it comes to our health and safety.
Source: The New York Times – Business Day (Saturday, November 20, 2010)

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