FDA experts recommend ban on Darvon

fda bans darvon

Food and Drug Administration (FDA) medical experts are recommending a ban on Darvon, a widely prescribed painkiller because of concerns about their addictive effects.

The said drug, developed by Eli Lilly & Co. (LLY), has been around for 50 years. Later, the company combined propoxyphene with another pain ingredient, acetaminophen, and sold the pill as Darvocet. The drug remains one of the top 25 most commonly prescribed medications. More than 20 million prescriptions were written in 2007.

“It has unique risks and no unique advantages,” said Dr. Sidney Wolfe, a drug safety expert with Public Citizen who first sought a ban in the 1970s. “It has been a big drug of abuse for quite a long time.”

Dr. Jerry Avorn, a professor of medicine at Harvard and a critic of the pharmaceutical industry, is thankful the FDA is taking a hard look at Darvon.

“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 version of Darvon sold in the United Kingdom was banned in 2005 after similar concerns about its potential for abuse were raised.

A new data from the Drug Abuse Warning Network showed that Darvon-related deaths rose to 503 in 2007, from 446 in 2006. Data from the Florida’s medical examiner reporting system showed that in 2007 Darvon was present in the bodies of 341 people who died from drug-related causes.

The FDA, however, has allowed Darvon and Darvocet to remain in circulation with stiffer warnings, safety studies, and efforts to educate doctors and patients about their potential risks and benefits.