Government medical advisers have recommended a ban on Darvon, the prescription medicine that’s been around for more than 50 years, and which has been widely used. The drug, which is used to treat pain, has left a trail of problems such as addiction and suicide. A Food and Drug Administration advisory panel voted recently to recommend withdrawing Darvon. A hearing was held during which the risks and benefits of the drug were examined. The panel recommended at the conclusion of the hearing by a 14-12 vote to withdraw Darvon.
As we have reported previously, the FDA is not required to follow the recommendations of its advisers, but often does so. Darvon was first approved in 1957, when there were few alternatives for treating pain except aspirin and powerful narcotics. Now mainly marketed as Darvocet, which includes a dose of acetaminophen, the drug remains one of the top 25 most commonly prescribed medications. More than 20 million prescriptions were written in 2007.
Public Citizen had petitioned the FDA to withdraw Darvon because the drug offers relatively weak pain relief and poses an overdose risk, with the potential to be used in suicides. Dr. Sidney Wolfe, a drug safety expert with Public Citizen, who first sought a ban in the 1970s had this to say: “With a drug that has almost no evidence of benefit, any risk is unacceptable. Hopefully the FDA will follow the vote of its advisers.”
Two companies that market the drug — Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals – claim the medication is safe and effective when used as directed. In documents filed with the FDA, the companies said doctors need a range of options to treat pain, and noted that many other painkillers have become drugs of abuse — some with far worse consequences. Dr. Jerry Avorn, a professor of medicine at Harvard and a critic of the pharmaceutical industry, commended the FDA for taking a hard look at Darvon. He observed:
I have been astonished at how widely used this drug is .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.
It should be noted that the United Kingdom banned its version of Darvon in 2005. While the FDA can follow the Advisory Board’s recommendations and ban the drug, it may take other steps, such as requiring stiffer warnings, safety studies or special education efforts aimed at doctors and patients. Dr. Wolfe is recommending that the drug be withdrawn gradually, because some patients have become dependent on it.
In an analysis prepared for the hearing, the FDA’s safety office said it had searched the agency’s database of reported drug problems, but the result was “insufficient” to allow reviewers to make a clear-cut recommendation. The FDA’s safety office found more than 3,000 reports of serious problems. With the top three being suicide, drug dependence and overdoses. In a separate analysis, the FDA office that handles painkillers found Darvon to be a weak pain reliever. Most studies, according to the reviewers, show that in Darvocet, the widely used combination drug, the Darvon component appears to contribute “little or no” additional pain relief beyond that provided by the acetaminophen component.
Dr. Wolfe presented the advisory panel with new data from the government’s Drug Abuse Warning Network, which tracks emergency room visits and deaths. It said that Darvon-related deaths rose to 503 in 2007, from 446 in 2006. In both years, about 20% were suicides. The network covers only about one-third of the U.S. population. Data from Florida’s medical examiner reporting system showed that in 2007 Darvon was present in the bodies of 341 people who died of any cause. Medical examiners identified it as the cause of death in 85 cases. Hopefully, the FDA will follow the recommendation of the advisory panel and ban this drug. The benefits certainly don’t appear to override the risks that come with taking Darvon.
Source: Associated Press
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