Painkiller Darvon pulled because of risk to heart
The long-controversial prescription painkiller Darvon was pulled off the market Friday at the request of federal regulators.
Xanodyne Pharmaceuticals Inc., of Newport, Ky., which makes Darvon, agreed to withdraw the medication at the request of the Food and Drug Administration, the FDA announced. Companies manufacturing generic versions of the drug, known as propoxyphene, will also removing 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."
The FDA said it was advising doctors to stop prescribing the drug, and asked patients taking it to immediately contact their physicians to discuss switching to another medication.
The drug, an opioid, was first approved by the FDA in 1957 to treat mild to moderate pain. It 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 from the market. But in July 2009 the agency decided instead to leave it on the market with strong new warnings about its 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 elecrical activty of the heart" that can cause serious problems, including sudden death, the FDA said.
"With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the hearts," Gerald Del Pan, the FDA's director of the office of surveillance and epidemiology said.
Consumer advocates welcomed the announcement, but sharply criticized the agency for failing to take action sooner. Britain pulled the drug six years ago and the rest of Europe removed it more than a year ago, they noted.
About 120 million prescriptions have been filled for the drug in the United States since Britain removed the drug, said Sidney Wolfe of Public Citizen's Health Research Group, which has long called for the drug's removal.
"Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since the time the UK ban was announced," Wolfe said in a statement. He called the FDA's failure to act sooner a "serious indictment of the FDA's long-lasting unwillingness to protect people in this country from a deadly but barely effective painkiller."
Wolfe called for a congressional investigation into why it took the FDA so long to act.
During a briefing for reporters, Del Pan said regulators did not feel there was sufficient evidence to act prior to the latest data.
"The new information on the effects of the electrical activity on the heart was the final piece to the puzzle," he said.
Others said the move illustrated that the agency has become much more aggressive about removing unsafe drugs.
"It is a perfect example of how the FDA is now saving lives by reversing past approval decisions," said Diana Zuckerman of the National Research Center for Women & Families. "Patients and consumers will be healthier and live longer when the FDA is willing to put the public's health first, as it did today."
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| November 19, 2010; 12:23 PM ET
Categories: FDA, Food Safety and Recalls, Recalls, drug safety
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