In a parting rebuke to the Food and Drug Administration, outgoing Health, Education and Welfare Secretary Joseph A. Califno Jr. yesterday called for stronger warnings to patients and doctors on the dangers of the pain-keller, Darvon.
Califano decided seven weeks ago not to ban Darvon for the present, through hundreds of persons a year have been dying either from overdoses or from combining it with alcohol or other sedatives or depressants, legal or illegal.
But Carlifano simultaneously asked doctors not to prescribe it unless no other pain-keller would do. He asked patients not to request it and to ask for a substitute if it were prescribed.Darvon is currently the nation's third most prescribed drug.
Califano also told Eli Lilly and Co., Darvon's maker, it must conduct an educational drive among doctors to curb Darvon's use.
Thursday Califano saw the new Lilly statements -- labelled by the company as "warnings to doctors, but merely as "general cautions" to patients -- and found them inadequate.
In language approved by FDA and announced by that HEW agency in a laundatory press release Monday, Lilly told patients to "make sure" their doctors know they are taking "tranquilizers, sleeps aids, anti-depressants, anti-histamines" or any other drugs that make them sleepy. The first said such drugs increase Darvon's sedative effects and could cause overdosage.
It said "limit your use of alcohol while taking Darvon"; cautioned about possible physical dependence if Darvon is taken in large doses over a long period: and urged caution in driving or operating machinery while sedated.
Only near the end of a long satement, however, did the company say, "Extreme overdose may lead to unconsciousness and death."
The much longer and franker statement to doctors said in its first sentence, "You should be aware of the risks associated with improper use," and in the second that it has become "a major cause of drug-related deaths."
Califano yesterday urged Surgeon General Julius Richmond to review both Lilly statements with FDA. He said they provide "insufficient information" -- for example, they tell patients neither the maximum recommended dose nor signs of drug dependency, nor do they reflect the concern "that Darvon is a dangerous drug whose use should be avoided."
Lilly said yesterday Darvon is still "safe and effective when taken as directed," and pointed to the statement of Acting FDA Commissioner Sherwin Gardener Monday. He said he was "pleased" with Lilly's actions.
Dr. Richmond nonetheless said he has asked Gardener to review the matter and tell him what he is doing to meet the latest concerns.