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Darvocet Has Been Recalled, Should Have Been Earlier

Darvocet Has Been Recalled, Should Have Been Earlier - The prominent consumer watchdog Public Citizen is blasting the FDA for waiting too long before issuing a Darvon and Darvocet recall late last week.

In a statement issued on Friday, Public Citizen called for congressional hearings into FDA leadership, saying that negligence on behalf of the agency has resulted in between 1,000 and 2,000 additional Darvon and Darvocet deaths during the years after it should have recalled all propoxyphene drugs.

Darvon was first introduced in 1957, containing propoxyphene to relieve mild to moderate post-surgical pain. Today it is most commonly prescribed as Darvocet, which combines the active ingredient in Darvon with acetaminophen, the active ingredient in Tylenol. Darvocet has become one of the most 25 most commonly prescribed medications, which has been prescribed to more than 22 million people.

According to data from the Federal Drug Abuse Warning Network, deaths related to Darvocet, Darvon and other generic propoxyphene drugs accounted for over 5% of all drug-related deaths between 1987 and 2006.

Public Citizen’s statement, issued by Dr. Sidney Wolfe, director of the organization’s health research wing, points out that Public Citizen first petitioned the FDA for a Darvocet and Darvon recall in 1978, when there was already evidence that propoxyphene-based drugs had limited effectiveness, were addictive, and could cause toxins to build up in the heart. However, according to the FDA recall announcement last week, the agency only recently received enough data to justify that the risks of Darvon and Darvocet side effects outweighed its health benefits.

Darvocet Has Been Recalled, Should Have Been Earlier
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