Personal Injury Law

Darvocet To Be Removed From Market After FDA Findings

By Mark Siesel, Esq.

The controversial drug propoxyphene, sold under the brand names Darvocet and Darvon, will be withdrawn from the market after 53 years due to serious heart risks, according to an announcement by the Food and Drug Administration (FDA) on November 19, 2010. The studies reviewed by the FDA determined that the drug caused dangerous heart electrical changes in otherwise healthy people. The removal of propoxyphene ends a 32 year crusade by the Health Research Group of Public Citizen, a consumer advocacy group out of Washington, to stop manufacture of the drug.

An FDA advisory committee voted 14-12 to remove the dangerous drug from the market in January of 2009, and it unclear why it took almost 2 additional years before the removal was finally effectuated. Great Britain banned the drug in 2005 and the European Union followed in 2009 after reports of an unusual number of deaths in Florida, where medical examiners do more toxicology studies.

There was some opinion that patients with severe pain might be switched to other medications which could cause more sedation, dizziness and falling. Medications that will most likely be used instead of Darvocet include Extra Strength Tylenol, Tramadol and low doses of hydrocodone or oxycodone. Propoxyphene was the 38th most prescribed drug in 2009 according to SDI/Verispan, a medicine information company, with 17.5 million prescriptions in the United States.

According to John J. Jenkins, director of the Office of New Drugs at the Food & Drug Administration, "the benefits of [propoxyphene] no longer outweigh its serious heart risks." The drug had been on the market since 1957, when it was manufactured by Eli Lilly, which profited in the billions from the drug until it sold the rights to Xanodyne Pharmaceuticals in 2005. Xanodyne voluntarily agreed to withdraw the drug after hearing last week from the FDA.

Full post as published by New York Legal Blog on November 24, 2010 (boomark / email).