The Ban: How Many Lives Did Darvocet Delay Cost?

Washington, DCIf the US Food and Drug Administration (FDA) had listened to Public Citizen and heeded its various petitions to ban Darvon and Darvocet from the market, Cornelius Kellehar might be alive today. The Tennessee man died from a sudden heart problem after taking propoxyphene for a period of three months. His death came mere days prior to the ban.

However, the ban could have happened much sooner had the FDA responded to various communiqués—and even a lawsuit—filed by the well-known advocacy group, alleging harmful Darvocet side effects.

A timeline shows that Public Citizen tried to get propoxyphene banned in early 2006, according to a petition filed with the FDA on February 28 of that year. Two years later there was a lawsuit, as the advocacy group dug in its heels and sought a response to its request for a ban of two years prior.

That was in June 2008. Nearly eight months later, in January 2009, testimony presented before an expert FDA panel revealed—and the FDA finally concurred—that the risks associated with Darvocet side effects outweighed the benefits.

Even so, on July 7 of that year, the FDA again denied the Public Citizen petition to ban Darvon and Darvocet.

Undaunted, a month later Public Citizen was back to the FDA—by this time under new leadership at the behest of the Obama Administration—with a renewed request to ban the Darvon medication, as well as Darvocet. Joining Public Citizen in its latest petition was Dr. Donald Kennedy, a former commissioner of the FDA, who outlined in remarks why he—as FDA Commissioner—allowed propoxyphene to remain on the market following a petition of concern way back in 1978…

"As Commissioner of the FDA in 1978, I received a petition from the Health Research Group (HRG) that urged me to initiate proceedings to ban Darvon and its formulations in combination with over-the-counter analgesics. The evidence offered considered the involvement of propoxyphene in a number of Drug Abuse Warning Network reports involving deaths of persons having taken these drugs, often in combination with alcohol or other abused drugs. The HRG petition also pointed to evidence that propoxyphene itself, in amounts equivalent to that used in the combinations, was less effective than the combined drugs required to be ordered by prescription.

"At the time, I judged that numbers of persons, including elderly patients suffering from arthritis, depended on the Darvon compounds—and that a ban could be harmful for that cohort.

"That was over three decades ago. Now actions in the United Kingdom and the European Union have taken account of new efficacy studies that confirm earlier doubts about the need for propoxyphene, and have enhanced the estimates of risks associated with this opioid drug. Indeed, the results of its withdrawal from the British market demonstrate that the risks of continued use substantially outweigh the benefits of continued availability—especially considering that now propoxyphene is available in a wider variety of generic forms.

"Accordingly, I would have made a different decision today."

It should be noted that the FDA advisory panel identified that in its view, the risks associated with the Darvocet drug far outweighed the benefits. The decision to pull Darvocet off market came in November 2010—twenty-two months later.

It could be argued that the propensity to move at a snail's pace with regard to the eventual Darvon recall cost Cornelius Kellehar his life. A Darvocet lawsuit was filed on his behalf by Kellehar's estate in January in US District Court for the Western District of Tennessee. Propoxyphene had been on the market since 1957. The FDA estimated that as many as 10 million prescriptions had been filled for Darvon and Darvocet in 2009 alone, the year the FDA advisory panel concluded that it was dangerous. Attorneys estimate the number of claims will be massive.