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Ban of Darvon Recommended by FDA Advisory Panel

Posted on: June 6th, 2015 by admin No Comments

A government advisory board is urging a ban of Darvon (propoxyphene), a prescription pain killer also known as Darvocet, after more than 50 years on the market. The drug is considered dangerously addictive, and is linked to numerous suicides as well as deaths from overdose.

After spending a full day examining and weighing evidence of the drug’s risks and beneficial uses, the US Food and Drug Administration’s medical advisory panel on January 30, 2009 voted 14 to 12 for recommending that the drug be pulled from the market.

In 2005 the United Kingdom banned their version of the pain medication because benefits didn’t outweigh risks.

First approved in 1957, Darvon became one of the few painkillers available other than strong narcotics and the simple aspirin. Sold today mainly as Darvocet, which includes acetaminophen, Darvon is among the top 25 medications prescribed. Physicians wrote more than 20 million of these prescriptions in 2007 alone.

The government advisory panel recommendations come after a national public advisory organization, Public Citizen, petitioned the FDA to ban Darvon and then filed a lawsuit against the FDA for failure to act. Darvon, Darvocet and drugs containing propoxyphene are not any more effective in relieving pain as other, less harmful drugs, said the group. Public Citizen first petitioned for a ban of Darvon in the 1970s, and says the drug has been linked to at least 2,000 deaths.

Public Citizen health research expert Dr. Sidney Wolfe said the FDA should phase out the medication because millions of patients are put at risk by taking it when safer and more effective pain medications are available. He hopes the FDA will follow the advisory panel’s recommendations, and he recommends a gradual withdraw because so many patients are currently using and dependent on Darvon.

Companies that market the medication, Qualitest/Vintage Pharmaceuticals and Xanodyne Pharmaceuticals, do not agree that Darvon should be banned. They say Darvon is safe when it is used as directed, and that other pain medications have also been abused.

Harvard professor Dr. Jerry Avorn, a pharmaceutical industry watchdog, says just because other prescription pain medications are abused and considered worse than this one does not make Darvon good for use. He commended the FDA for investigating the drug.

In preparing evidence for the FDA hearing, the government’s safety office uncovered 3,000 plus reports regarding serious problems with Darvon. The FDA also found that Darvocet offers almost no additional benefits for pain relief over that provided by the acetaminophen included in it.

Evidence from the Drug Abuse Warning Network, a national public health system that monitors about a third of the US population’s emergency room drug-related visits and deaths, show Darvon deaths rose greatly. The evidence showed 446 deaths in 2006 and 503 the following year that were related to Darvon, 20 percent of which were listed as suicides.

Even if a ban of Darvon, or request for removal of the product, is not issued the FDA will likely take additional measures to ensure the public is aware of and protected from the risks involved with its use.

SOURCE: ASSOCIATED PRESS