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FDA Reviewing Painkiller Darvon, 50 Years After Initial OK

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Darvon, a painkiller approved more than 50 years ago, is being reviewed by the U.S. Food and Drug Administration after critics charged it provided little relief and posed a risk for overdoes and suicides, the Associated Press reported Friday.

Chiefly marketed as Darvocet, the drug, which includes a dose of acetaminophen, is one of the top currently prescribed medications. More than 20 million prescriptions were written in 2007, the wire service said. Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals, two firms that market Darvocet, called the medication safe and effective when used as directed.

But critics complained that the government review was too long in coming. "[The drug] has unique risks and no unique advantages," Dr. Sidney Wolfe, a drug safety expert with the consumer group Public Citizen, told the AP. "It has been a big drug of abuse for quite a long time." Public Citizen first sought a ban on Darvon in the 1970s, and the United Kingdom banned its version in 2005, the AP said.

The FDA, which was awaiting recommendations Friday from a panel of independent advisers, was unlikely to go so far as banning the drug but could require stiffer warnings, additional studies or education efforts to alert doctors and patients of potential misuses, the AP reported.

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