-March 1, 2006
Consumer advocacy group, Public Citizen, has petitioned the U.S. Food and Drug Administration to ban popular painkillers Darvon, Darvocet and similar generic versions from the market because the drugs have been linked to a significant number of death reports, are highly addictive, and are not very effective.
Since 1981, at least 2,110 reported accidental deaths were associated with propoxyphene, the main active ingredient in the painkillers, which is highly poisonous to the body and causes serious adverse side effects including a variety of heart problems.
Propoxyphene drugs were prescribed to 23 million people in 2004, making it the 12 th most commonly prescribed drug in the U.S. However, recent studies found that propoxyphene combined with acetaminophen found in many generic painkillers “offered little benefit over acetaminophen alone” in treating pain.
“This is a black-and-while example of a drug where its risks far outweigh its benefits,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “There’s no excuse for this drug to be around.”
In addition to the unacceptable risks the weak painkillers pose, the drugs are also highly addictive. According to Leah Young, spokeswoman for the Substance Abuse and Mental Health Services Administration, propoxyphene-containing drugs are among the country’s most widely abused painkillers. Approximately 21 million people had made “non medical” use of the drugs in 2004, young said.
Pubic Citizen first petitioned to ban propoxyphene in 1978. The agency’s most recent petition calls for a phase out similar to the British government’s decision last year, rather than an immediate ban due to the highly addictive quality of the drug.
“The Food and Drug Administration should immediately begin phasing out the use of propoxyphene,” said Wolfe. “Millions of people.are being put at risk when using this drug when there are safer, more effective alternatives available. We agree with the British government’s conclusion that the efficacy of this product ‘is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable.’”
The FDA has 180 days to respond to petitioners. Wolfe said Public Citizen may not wait to take legal action against the FDA to get the drugs off the market.
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