Popular painkillers taken off the market
Popular painkillers taken off the market
Popular painkillers taken off the market
Popular painkillers taken off the market
Although still in wide use more than a half-century after introduction, Darvon and Darvocet and their generic counterparts are easily replaceable, pain management experts said Friday (Nov.19,2010) after the Food and Drug Administration asked that the popular painkillers be removed from the U.S. marketplace.
The FDA's decision, based on data showing a risk of serious heart rhythm abnormalities, caps years of controversy about the dangerous side effects of Darvon -- known generically as propoxyphene -- which was first approved by regulators in 1957.
Sidney Wolfe of Public Citizen's Health Research Group blasted the FDA's action as too late and called for congressional hearings into why the agency took so long to move.
In calling for withdrawal of the drug, the FDA urged doctors to stop prescribing it immediately. But it advised patients to continue taking propoxyphene while consulting quickly with physicians to arrange for alternative medication.
Propoxyphene, an opioid, is used to treat mild to moderate pain.
The FDA estimated that propoxyphene was used by 10 million people in 2009, with most of them receiving the drug in combination with acetaminophen, a compound known by the Darvocet trade name.
Many doctors who prescribe propoxyphene do so simply because it's been around so long and they're familiar with it, said Al Anderson, a Minneapolis family practitioner and president of the American Academy of Pain Management board of directors.
Anderson said the withdrawal will hurt a small number of patients who can't tolerate other painkillers, but for most patients, there are many alternatives, such as oxycodone, morphine and Nucynta.
"It certainly takes one tool away, but it's a small tool," said Anderson.
"We have many better options," said Mehul Desai, director of pain medicine at George Washington University Hospital, in Washington. "It tends to be a pretty poor pain reliever."
Propoxyphene was effectively pulled from the market because of health concerns by regulators in Britain in 2005 and by the European Union in June 2009.
In January 2009, an FDA advisory committee voted 14-12 against continued marketing of propoxyphene.
The FDA rejected that recommendation, but required a study of the drug's cardiac effects. The study showed an increased risks for heart arrthymias even in healthy patients, not just those weakened by illness.
"We concluded that the pain relief benefit no longer outweighed the health risks," said John Jenkins, director of new drugs in FDA's Center for Drug Evaluation and Research, in a telephone press conference with reporters.
The FDA should have acted much sooner, said Wolfe. Public Citizen tried for more than three decades to limit use of the drug and petitioned the FDA to ban it in 2006.
Data about heart toxicity cited by the FDA in Friday's announcement was available from an animal study 30 years ago, according to Wolfe, who said that at least 1,000 people in the U.S. have died from using propoxyphene since the 2005 ban in Britain.
He labeled the agency's inaction "a serious indictment of the FDA's long-lasting unwillingness to protect people in this country from a deadly but barely effective painkiller."
But judged against its regulatory behavior in recent years, Friday's(Nov.19,2010) announcement continues a harder FDA line on drug safety. It's the second time in six weeks the agency pushed to have a drug removed from the market.
Darvon and Darvocet are made by Xanodyne Pharmaceuticals Inc., of Newport, Kentucky, which said it would comply with the FDA's request to withdraw the drug. Generic makers of propoxyphene are expected to follow suit.
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