Now that the FDA has recalled Darvon and Darvocet, manufactured with propoxyphene, an opiod painkiller, attention and criticism have been focused on the slow response of the governmental agency to remove the painkillers from the US marketplace. It’s well-documented that the advocacy group Public Citizen has been calling for the drugs’ removal from the marketplace since 1978. Other countries have removed the drugs much more quickly, including the entire European Union. Dr. Sidney Wolfe told the FDA that the drugs were relatively weak and weren’t effective especially given their potential serious adverse consequences which include fatal abnormal heart rhythms, arrhythmia, bradycardia, cardiac/respiratory arrest,congestive arrest, congestive heart failure (CHF),tachycardia,
and myocardial infarction (MI).
In response to the recall, Public Citizen released the following statement, “Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since time the UK ban was announced,” the group said in a statement. “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. If data from 2007 are representative, in that year, 78 percent of the Florida deaths caused by propoxyphene were ruled accidental.”
There is little doubt in the medical and scientific communities that these are dangerous drugs. Yet, because of the FDA’s inaction, thousands have been prescribed these painkillers in the United States. Little to no information is available as to what caused the years of inaction by the FDA. Because of this delay, consumer safety and consumer confidence have been dealt another blow.
Darvocet Recall