Darvon and Darvocet: Popular Pain Killers Facing Possible Ban
More than 50 years after first landed on pharmacy shelves in the United States, the potent painkiller Darvon and a modern use of the drug called Darvocet are back in the spotlight and facing a possible ban now that more effective ways of fighting pain are available.
Darvon, which is commonly combined with a dose of acetaminophen and marketed under the name Darvocet, was first approved for use in the United States in 1957. Darvocet is one of the most commonly prescribed drugs in the United States, with more than 20 million prescriptions written in 2007.
Consumer rights groups are now urging the Food and Drug Administration to recall both Darvon and Darvocet since they say the drugs pose an unreasonably high overdose risk and provide relatively weak pain relief when compared to other, newer pain killers. A public hearing on the issue is being held on January 30, 2009.
Is Darvon Safe, or Dangerously Outdated?
The two companies that market Darvocet are Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals. Officials with those pharmaceutical firms say their drug is safe and effective when used as directed. The companies have told the FDA that Darvon and Darvocet give physicians another effective tool in the range of pain-fighting options.
But officials with the consumer group Public Citizen, which is leading the charge to remove Darvon, say the drug has “unique risks and no unique advantages,” including a high risk of addiction and abuse and frequent use in suicides by overdose.
The drug’s manufacturers say the threat of addiction and abuse is not unique to Darvon and is present in many painkillers.
As for the effectiveness of the drug, the FDA has said Darvon is “a weak pain reliever.” Most medical studies have found that when used in Darvocet, the Darvon component appears to be unnecessary, contributing “little or no” additional pain relief beyond that which is already provided by the acetaminophen component of the drug, reviewers said.
Serious Problems Have Been Reported
The FDA has found more than 3,000 reports of serious problems associated with the use of Darvon and Darvocet. Suicide, drug dependence, and overdoses were the most commonly reported problems.
Data from the Drug Abuse Warning Network, a government database which tracks emergency room visits and deaths, shows there were 503 Darvon-related deaths in the United States in 2007, which was an increase from 446 reported in 2006.
About 20 percent of those deaths were reported as suicides. Since the network covers only about one-third of the U.S. population, the actual nationwide numbers of deaths tied to Darvon use are much higher.
The Florida state medical examiner reports that in 2007, Darvon was present in the bodies of 341 people who died from drug-related causes. The drug was named as the cause of death in 85 of those cases, roughly one in four.
Banned in the U.K.
The version of Darvon sold in the United Kingdom was banned in 2005 after similar concerns about its potential for abuse were raised. The U.S. FDA, however, has allowed Darvon and Darvocet to remain in circulation with stiffer warnings, safety studies, and efforts to education doctors and patients about their potential risks and benefits.
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