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August 24, 1979

Lilly to provide consumer leaflet on Darvon

JAMA. 1979;242(8):702-703. doi:10.1001/jama.1979.03300080004002

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In the continuing saga of the widely used pain-killing drug propoxyphene hydrochloride, Eli Lilly and Company, the principal manufacturer of the drug, has agreed to voluntarily distribute a warning on the hazards of using its product (Darvon) in excess or in combination with other drugs.

The Food and Drug Administration has announced that the new consumer leaflet will be available from pharmacists when prescriptions for Darvon are filled.

"Darvon is a safe drug when used properly," said acting FDA Commissioner Sherwin Gardner. He added, however, that there is a "potentially lethal" risk involved when the drug is used with alcohol, tranquilizers, or sedatives.

On his last day in office, however, former HEW Secretary Joseph Califano criticized the warnings as inadequate. He said that they fail to mention such things as the maximum recommended dose or the signs of drug dependency.

Lilly manufactures at least 80% of the propoxyphene used in