Personal Injury Law

FDA Expert Panel Recommends Darvon Ban

By Jane Akre

An expert panel advised the Food and Drug Administration Friday that the painkiller, Darvon should be banned. 

Darvon has been on the market since 1957, but in a 14-12 vote,  the panel said it provides little relief and has the downside of suicide and an overdose risk. 

Generally the FDA follows the expert's advice, but not always. 

Dr. Sidney Wolfe of Public Citizen tells the Associated Press, "It has been a big drug of abuse for quite a long time."  Public Citizen had encouraged the FDA to ban Darvon in the 1970s. In his presentation to the advisory panel, Dr. Wolfe included data from the Drug Abuse Warning Network, which tracks ER visit and deaths.

DAWN includes more than 500 Darvon-related deaths in 2007, with about 20 percent being suicides.  446 were reported the previous year and the network reportedly does not cover the entire U.S.

Darvon, including a dose of acetaminophen is called Darvocet and prescribed about 20 million times in the U.S. annually. The FDA has the option of requiring a black box, the most serious warning label a drug can carry. 

Darvon's distributors Zanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals says the medication is safe when used as directed.  AP reports it is one of the most commonly prescribed medications.

Dr. Jerry Avorn, a professor of medicine at Harvard tells AP the tough look at Darvon should be commended. "I have been astonished at how widely used this drug is," Avorn said. "It's no longer the most abusable and most dangerous drug in its class, but the fact that there are worse drugs doesn't make Darvon a good drug."

The UK banned Darvon in 2005. #

Full post as published by InjuryBoard on February 02, 2009 (boomark / email).