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Originally published November 27 2009

FDA Warns on Overdose Risk for Darvon and Darvocet Painkillers

by David Gutierrez, staff writer

(NaturalNews) The FDA has issued a warning about the high overdose risk from the opiate painkillers Darvon and Darvocet, but has stopped short of banning the drugs as the United Kingdom has done.

Darvon and Darvocet contain a mix of an over-the-counter painkiller (either aspirin or acetaminophen) and the opiate propoxyphene, also known as dextropropoxyphene. The new FDA rules will require a tougher boxed warning on all products containing propoxyphene about the particular danger that the drugs pose when taken at higher-than-recommended doses.

"FDA is taking action to reduce the likelihood of such fatal overdoses in the United States while we investigate the safety of propoxyphene more fully," the agency said. "In Europe, there is recent evidence that this medication may be more lethal in overdose than other pain medications."

After the propoxyphene-acetominophen combination marketed in the United Kingdom as co-proxamol was withdrawn from the market in that country, the number of suicides and accidental overdoses from painkillers fell dramatically. Approximately 295 fewer people committed suicide with co-proxamol and 54 fewer people died from accidents involving the drug over a two-year period, with no corresponding increase in suicides or accidental poisonings using other painkillers.

"Major changes in prescribing after the announcement of the withdrawal of co-proxamol have had a marked beneficial effect on poisoning mortality involving this drug, with little evidence of substitution of suicide method related to increased prescribing of other analgesics," Oxford University researchers concluded in a recent study.

The FDA's ruling came in response to a petition by the consumer advocacy group Public Citizen, which had also requested that the drug be phased out of the U.S. market. Although an FDA advisory panel also voted 14-12 in favor of withdrawing the drug, the agency decided only to strengthen warnings on the drug and conduct further research at this time.

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