Darvon and Darvocet may very well hold the distinction of being the drugs with the longest history of being permitted to remain on the market while under a cloud of suspicion due to serious safety concerns.
In 1957 propoxyphene was approved for sale in the United States under the brand name of Darvon and Darvocet (which is propoxyphene + acetaminophen) by Eli Lilly, a multi-national drug company based in Indianapolis, Indiana. And, in 1976 it became a Schedule IV Controlled Substance, which was approved by the FDA for use to treat mild to moderate pain.
The following information is a summary of Public Citizen’s, a non-profit advocacy group, 30 year battle to recall this drug:
- In 1978 Public Citizen filed a consumer petition calling for a recall of Darvon and Darvocet because of safety issues.
- In 2006 Public Citizen renewed their call for the recall of Darvon and Darvocet as well as generic formulations of the products due to heart-related harm.
- In June 2008 Public Citizen filed suit against the Food & Drug Administration for failing to timely act on its petition to remove the medications from the market.
Then in January 2009, a FDA Advisory Panel convened and voted 14 to 12 in favor of removal of the drug from the market in the United States, but the FDA permitted Xanodyne and various generic manufacturers to continue selling the drugs. At this time, the FDA also formally denied the 2006 petition filed by Public Citizen and restated the Agency’s opinion that the benefits of Darvon and Darvocet outweighed the risks based upon current data.
The same year, in June, the European Union equivalent of the FDA recommended that Darvon and Darvocet as well as generic formulations of propoxyphene no longer be sold in the EU, and a phased withdrawal of the product was implemented.
However, in July 2009 FDA decided to continue to permit sales of Darvon and Darvocet, but enhanced the warning label to include a “black box warning” regarding the risks of fatal overdoses. The Agency also requested that Xanodyne conduct a new safety study to further evaluate the long-standing concerns that the drugs were dangerous to the heart.
In November 2009, the FDA reviewed additional data submitted by Xanodyne which shows that propoxyphene, when taken at recommended doses, causes significant changes in the electrical activity of the heart, which can lead to a number of life-threatening complications including arrhythmia and sudden cardiac death. The data also showed that patients who have taken the drugs for years, which was quite common, could still face serious heart risks if they had other changes in the medication, dehydration, or impaired renal function. In the face of this data (and presumably at the threat of an FDA recall), Xanodyne agreed to voluntarily withdraw Darvocet and Darvon from the US market.
And, now in August 2011, after a delay of several months, the Judicial Panel on Multi-District Litigation announced the establishment of MDL proceedings in the Eastern District of Kentucky before District Court Judge Danny C. Reeves for the Darvon and Darvocet cases. The petition seeking pre-trial consolidation and MDL coordination had been filed in late 2010 after the recall or market withdrawal of Darvocet and Darvon and their generic counterparts that contain propoxyphene.