FDA Questions 50-Year-Old Painkiller
On Friday, federal health officials got together for a public hearing on whether to ban Darvon, a painkiller first approved in 1957.
The drug, now known as Darvocet, includes a dose of acetaminophen and remains one of the top 25 most commonly prescribed medications. Over 20 million prescriptions were written in 2007.
Public Citizen, a consumer group, said the FDA should withdraw Darvon from the market because the drug offers relatively weak pain relief and poses an overdose risk, with the potential to be used in suicides.
"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."
Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals, companies that market the drug, say the medication is safe and effective when used as directed. They also say the doctors need a range of options to treat pain, and note that many other painkillers have become drugs of abuse.
A professor of medicine at Harvard and a critic of the pharmaceutical industry, Dr. Jerry Avorn, is glad 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."
In 2005, the U.K. banned its version of Darvon. The FDA might be more cautious, requiring stiffer warnings, safety studies or special education efforts aimed at doctors and patients.
Friday, the FDA waited for a panel of independent advisers.
The FDA’s safety office said in an analysis that it had searched the agency’s database of reported drug problems, but it resulted as "insufficient" to allow reviewers to make a clear-cut recommendation. Over 3,000 reports were found by the safety office of serious problems. The top three were suicide, drug dependence and overdose.
Another analysis by the FDA office that handles painkillers said that Darvon is a weak pain reliever. The majority of other studies show that in Darvocet, the Darvon component appears to contribute "little or no" additional pain relief beyond that provided by the acetaminophen component, according to reviewers.
Wolfe presented the advisory panel with data from the government’s Drug Abuse Warning Network. The data showed that Darvon-related deaths went from 446 in 2006, to 503 in 2007. Twenty percent in both years were suicides. The network only covers about one-third of the U.S. population.
In 2007, Darvon was present in the bodies of 341 people who died from drug-related causes, according to data from the Florida’s medical examiner reporting system. They identified it as the cause of death in 85 of the cases.
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