No more Darvon for U.S. market: FDA - Did You Know Darvon Was Pulled off Market by FDA in Nov 2010 Because It Can Cause Heart Problems, In The Video Attached FDA Says Its a Low Risk
By Maggie Fox|
Health and Science Editor
WASHINGTON | Fri Nov 19, 2010
(Reuters) - 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 U.S. Food and Drug Administration said on Friday.
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 U.K. 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.
"Over a five-year period, the number of drug-related deaths was approximately 16 deaths per 100,000 prescriptions for propoxyphene, 10 deaths per 100,000 prescriptions for tramadol and 8 deaths per 100,000 prescriptions for hydrocodone," the FDA said in a statement.
The FDA said it was advising healthcare professionals to stop prescribing propoxyphene and said patients taking it should speak to a doctor about switching to another drug as soon as possible.
"Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks," the FDA said.
The FDA's Dr. Gerald Dal Pan said Darvon does not cause permanent damage to the heart. "Once patients stop taking propoxyphene, the risk will go away," he said.
FDA NEWS RELEASE
For Immediate Release: Nov. 19, 2010
Media Inquiries: Karen Riley, 301-796-4674, email@example.com
Consumer Inquiries: 888-INFO-FDA
Xanodyne agrees to withdraw propoxyphene from the U.S. market
Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food and Drug Administration. The FDA has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne's decision and requested that they voluntarily remove their products as well.
The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.
"The FDA is pleased by Xanodyne's decision to voluntarily remove its products from the U.S. market," said John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research (CDER). "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."
The FDA is advising health care professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy.
Propoxyphene is an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxyphene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).
Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug.
In January 2009, the FDA held an advisory committee meeting to address the efficacy and safety of propoxyphene. After considering the data submitted with the original drug applications for propoxyphene, as well as subsequent medical literature and postmarketing safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug's cardiac effects would be relevant in weighing its risks and benefits.
In June 2009, the European Medicines Agency (EMEA) recommended that the marketing authorizations for propoxyphene be withdrawn across the European Union. A phased withdrawal of propoxyphene is underway.
In July 2009, the FDA decided to permit continued marketing, but required that a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of a fatal overdose. In addition, the agency required Xanodyne to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart.
The agency now has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death. The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.
"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 heart," said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology, CDER. "However, long-time users of the drug need to know that these changes to the heart's electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away."
Xanodyne is based in Newport, Ky.
Press Announcements > Xanodyne agrees to withdraw propoxyphene - FDA - link to video from the FDA
Nov 19, 2010 ... First approved by the FDA in 1957, propoxyphene is sold by prescription under various names both alone (e.g., Darvon) or in combination with ...
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