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No more Darvon for US market - FDA
Source: Agencies |
November 20, 2010, Saturday
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THE company that makes the highly popular narcotic painkiller Darvon has pulled the drug from the market because it can cause fatal heart rhythms, the US Food and Drug Administration said yesterday.
The FDA said it asked Kentucky-based Xanodyne Pharmaceuticals Inc to stop selling Darvon and Darvocet after new data confirmed fears that the active ingredient, propoxyphene, could cause serious or even fatal heart rhythm abnormalities.
The decision means patients will have even fewer safe options to manage pain, the FDA said. The agency says 10 million patients took Darvon or a generic version in 2009 and 18 million prescriptions were dispensed.
"These new heart data significantly alter propoxyphene's risk-benefit profile. The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks," Dr. John Jenkins of the FDA's Center for Drug Evaluation and Research said in a statement.
Dr. Sidney Wolfe of the Public Citizen's Health Research Group said it was too little, too late, noting that Britain banned the drug six years ago.
"Due to FDA negligence, at least 1,000 to 2,000 or more people in the United States have died from using propoxyphene since the time the UK ban was announced," Wolfe said in a statement.
An FDA advisory committee split on whether to ban the drug in 2009. The European Medicines Agency pulled it from the market in June 2009.
"The FDA's pitiful excuse that it needed to order a human study to find that 'the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities' before deciding whether to ban propoxyphene only emphasizes how out-of-step the agency is with the rest of the world," Wolfe said.
But the FDA noted that many people take the drug and that there are few choices equivalent to the mild opioid. These include over-the-counter pain relievers such as aspirin, ibuprofen and acetaminophen, codeine, oxycodone or hydrocodone.
Aspirin and ibuprofen can cause fatal bleeding and codeine can cause severe constipation.
The FDA said it was difficult to show that deaths associated with Darvon use were not, in fact, overdoses. But a comparison with similar drugs showed propoxyphene was more dangerous.
The FDA said it asked Kentucky-based Xanodyne Pharmaceuticals Inc to stop selling Darvon and Darvocet after new data confirmed fears that the active ingredient, propoxyphene, could cause serious or even fatal heart rhythm abnormalities.
The decision means patients will have even fewer safe options to manage pain, the FDA said. The agency says 10 million patients took Darvon or a generic version in 2009 and 18 million prescriptions were dispensed.
"These new heart data significantly alter propoxyphene's risk-benefit profile. The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks," Dr. John Jenkins of the FDA's Center for Drug Evaluation and Research said in a statement.
Dr. Sidney Wolfe of the Public Citizen's Health Research Group said it was too little, too late, noting that Britain banned the drug six years ago.
"Due to FDA negligence, at least 1,000 to 2,000 or more people in the United States have died from using propoxyphene since the time the UK ban was announced," Wolfe said in a statement.
An FDA advisory committee split on whether to ban the drug in 2009. The European Medicines Agency pulled it from the market in June 2009.
"The FDA's pitiful excuse that it needed to order a human study to find that 'the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities' before deciding whether to ban propoxyphene only emphasizes how out-of-step the agency is with the rest of the world," Wolfe said.
But the FDA noted that many people take the drug and that there are few choices equivalent to the mild opioid. These include over-the-counter pain relievers such as aspirin, ibuprofen and acetaminophen, codeine, oxycodone or hydrocodone.
Aspirin and ibuprofen can cause fatal bleeding and codeine can cause severe constipation.
The FDA said it was difficult to show that deaths associated with Darvon use were not, in fact, overdoses. But a comparison with similar drugs showed propoxyphene was more dangerous.
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