A consumer group says negligence on the part of federal regulators in calling for a Darvon and Darvocet recall likely cost hundreds of lives. In a recent issue of its “Worst Pills, Best Pills” newsletter, Public Citizen says that the U.S. Food & Drug Administration (FDA) should have pulled Darvon, Darvocet and other drugs made with propoxyphene from the market years before it finally did.
Propoxyphene is an opiod painkiller that was first sold as Darvon in 1957. Darvocet is a combination drug made with propoxyphene and acetaminophen. The U.S. Food & Drug Administration (FDA) finally asked the makers of propoxyphene products to pull them from the market in November, after a study conducted by Xanodyne Pharmaceuticals, the maker of the popular painkillers, found out an irregular heartbeat to be linked to side effects of Darvon and Darvocet. This condition, called QT prolongation, lengthens the time between the Q wave and T waves, which are two of five electrical impulses that measure the regularity of a heartbeat. There are no symptoms of this condition, but it can lead to a potentially lethal rapid heartbeat called ventricular tachycardia.
In its newsletter, Public Citizen points out that it petitioned the FDA twice starting in 1978 to ban propoxyphene. The group contends that for more than 30 years, evidence has shown that propoxyphene is not very effective, is toxic at doses not much higher than the recommend dose, and is somewhat addictive.
According to Public Citizen, the U.K. banned propoxyphene in 2005, stating that its efficacy of propoxyphene “is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable” and that “in relation to safety, there is evidence that fatal toxicity may occur with a small multiple of the normal therapeutic dose and a proportion of fatalities are caused by inadvertent overdose.”
Yet the FDA continues to insist that the recent study that finally prompted it to ban propoxyphene provided the first evidence that the drug is dangerous at the “standard therapeutic dose.”
Public Citizen further states:
“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 U.K. ban was announced. The best forensic data the kind relied upon for the U.K. and European bans, come from Florida, where routine drug testing is required as part of many autopsies. Deaths are categorized as being caused by a particular drug if the amount of the drug found in the body is above a certain level.
From 2005 through 2009, in Florida alone, 395 deaths were caused by propoxyphene. If data from 2007 are representative, about 78 percent of the Florida deaths caused by propoxyphene
were ruled accidental.”
Since the propoxyphene ban was announced by the FDA, plaintiffs’ attorneys have reported that they are being inundated with inquiries from Darvon and Darvocet victims seeking to file defective drug lawsuits.
“The numbers are astronomical. It has the potential to be as big as fen-phen,” Jerrold Parker, a partner with the national law firm of Parker Waichman LLP, recently told the Daily Record. According to that report, Parker Waichman LLP has received as many as 1,000 phone inquiries per day since Darvon and Darvocet were recalled in November.
As we’ve reported previously, Parker Waichman LLP filed one of the first Darvocet lawsuits on behalf of Karen Esposito, a 31-year-old Queens, New York woman who claims to have suffered a near-fatal heart attack shortly after using the drug. In December, the firm petitioned the Judicial Panel on Multidistrict Litigation on Ms. Esposito’s behalf, seeking the consolidation of all federal lawsuits involving Darvon and Darvocet in a multidistrict litigation in U.S. District Court for the Eastern District of New York before the Honorable Jack B. Weinstein.