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.
The FDA’s decision came after the agency received new clinical data that propoxyphene-based drugs were linked to heart arrhythmia which could sometimes be fatal. The FDA indicated that that when the Darvon and Darvocet heart risks were combined with the risk of suicide, addiction and death, it was clear that the health risks overshadowed the benefits of the drug as a painkiller, which is not much more potent than most over-the-counter products.
Public Citizen said that the FDA’s claim “rings hollow” due to its own petition in 1978, as well as a decision by the U.K. to pull Darvocet and Darvon from that market in January 2005 after determining the drugs were too dangerous and had little benefit. Public Citizen again petitioned the FDA to recall the painkiller in 2006, and filed a lawsuit against the FDA in 2008 when the agency did not act on its petition.
Following the lawsuit, the FDA’s own advisory committee voted 14 to 12 to recommend a Darvon and Darvocet recall in January 2009 for the same reasons as the U.K.; that it was too dangerous and provided little health benefit. Less than two years ago, the entire European Union also announced a recall of the drugs.
“Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since [the] time the UK ban was announced,” Wolfe said. “The FDA’s pitiful excuse that it needed to order a human study to find that ‘the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities’ before deciding whether to ban propoxyphene only emphasizes how out-of-step the agency is with the rest of the world – which already had enough human evidence of death and near-death in tens of thousands of people to act accordingly.”
Wolfe announced that Public Citizen will push for a congressional investigation into the leadership of FDA’s Center for Drug Evaluation and Research (CDER), to determine who was responsible for the agency’s delay in taking action.
Following the recall, product liability lawyers are reviewing potential Darvon lawsuits and Darvocet lawsuits for individuals throughout the United States who have suffered serious or fatal injuries that may be related to their use of the pain medications.