The government apparently must limit production of the anti-pain drug, Darvon, as a result of a United Nations action placing the chemical in it on a list of narcotics whose use should be controlled.
Americans last year filled 22 million prescriptions for this widely used but controversial pain-killer. That figure is down 28 percent from 1978, but still a very large number.
Darvon's critics -- notably Ralph Nader's Health Research Group -- say it causes hundreds of deaths yearly from overdoes and abuses, including simultaneous use of tranquilizers or sleep-inducers.
The United Nations Commission on Narcotic Drugs voted in February to place propoxyphene, Darvon's active ingredient, on its International Narcotics Schedule II. This requires signers of a 1961 drug convention, including the United States, to set careful production quotas for the substances.
Eli Lilly and Co., Darvon's maker, said it believes the U.N. decision "is not justified."
Dr. Sidney Wolfe, the Nader Health group's director, yesterday urged the Drug Enforcement Administration and the Department of Health, Education and Welfare to take "the strongest possible action," including a limit on prescriptions, to reduce deaths and addition from Darvon overuse.
A DEA spokesman said the subject is under study, but setting production quotas on propoxyphene will be "automatic" unless the U.N. commission changes its mind. He called this unlikely.
The Nader group petitioned the government in November 1978 either to ban Darvon outright -- on the ground that it is no more effective than other pain drugs - or at least place it on this government's Schedule II for narcotic drugs.
This would require both production quotas and a ban on prescription refills without a doctor's recorder.
Joseph A. Califano Jr., then secretary of HEW, refused to ban Darvon, while collecting more information on abuses. But he asked doctors not to prescribe it. He asked patients not to ask for it, or to ask for a substitute if it were prescribed. He said Lilly had to educate doctors to limit its use.
Last August he said Lilly's new literature -- "warnings" to doctors but mere "general cautions" to patients -- was inadequate. Last month the Food and Drug Administration told Lilly it was still dissatisfied with its educational campaign.
Lilly has fought severe limits on Darvon's use, saying it is "safe and effective when taken as directed."