Controversial painkiller Darvon pulled at FDA’s request

By Rob Stein
Washington Post Staff Writer
Friday, November 19, 2010; 7:36 PM
Washington Post

A controversial prescription painkiller was pulled off the market Friday at the request of federal regulators because of concerns the drug can cause fatal heart problems.

Xanodyne Pharmaceuticals Inc., of Newport, Ky., which makes Darvon, agreed to withdraw the medication at the request of the Food and Drug Administration, the agency announced. Companies making generic versions of the drug, known as propoxyphene, will also remove their products, the FDA said.

The FDA sought the withdrawal after receiving new data showing that the drug put patients at risk for potentially fatal heart rhythm abnormalities, the agency said.

“These new heart data significantly alter propoxyphene’s risk-benefit profile,” the FDA’s John Jenkins said in a statement. “The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.”

Doctors should stop prescribing the drug, and patients taking it should immediately contact their physicians to discuss switching to another medication, the FDA said.

The opioid, first approved by the FDA in 1957 to treat mild to moderate pain, is sold under a variety of names, including Darvon, which is the drug alone, and Darvocet, which is the drug combined with acetaminophen.

The FDA has received two requests to remove the drug from the market since 1978 but had previously determined the benefits outweighed the risks. In January 2009, an FDA advisory committee recommended pulling the drug. But in July 2009 the agency decided instead to leave it on the market with strong new warnings about the risks and required the company to conduct a new study assessing its safety.

Friday’s action was based on the results of that study, which showed that “even when taken at recommended doses, propoxyphene caused significant changes to the electrical activity of the heart” that can cause serious problems, including sudden death, the FDA said.

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