Word: fda
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Dates: during 1960-1969
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Chloromycetin. which is Parke. Davis' trade name for the potent antibiotic chloramphenicol. got FDA approval in 1949. It attacked many bacteria against which penicillin was useless, notably the typhoid bacillus; equally important, it was the first effective drug against psittacosis (caused by an unusually large virus) and against such diseases as typhus, scrub typhus and spotted fever (caused by related microbes called rickettsiae ). Not until 1952, when hundreds of thousands of patients had had the drug-often for viral respiratory infections against which neither it nor any other antibiotic is effective-did evidence arise that it had caused...
...FDA got the National Academy of Sciences to set up a committee of topflight experts to study Chloromycetin...
...left on the market, but with a warning to doctors not to use it unless the illness was so severe as to justify the risk. Sales of Chloromycetin slumped, then gradually picked up until 1960, when a new flurry of alarm set off a second reevaluation. Once more, the FDA's expert advisers concluded that to take the drug off the market would bring death to more people than to leave...
Investigational Testing. The hard fact is that any potent drug is almost certain to have some dangerous incidental effects in some proportion of patients after it is widely used. To keep these backfires to a minimum. FDA first provisionally licenses a new drug"for investigational use only" (after testing in animals), whereupon most manufacturers get research physicians to try their product on 1,000 to 3,000 patients. It was this step-by-step procedure that fortuitously kept thalidomide. the sleeping pill now suspected of causing many malformations in babies in Europe and elsewhere (TIME...
Once a drug is licensed, if doubts about its safety arise the FDA must go through a complex, time-consuming procedure to get it off the market. Usually, in such cases, the drugmakers cooperate more or less voluntarily, since they have as much stake as anyone in weighing a drug's side effects against its advantages. Last week the Upjohn Co. withdrew Monase. a "psychic energizer,"after reporting to FDA that widespread use since June 1961 had produced seven cases of aplastic anemia, four of them fatal-though the drug was tested in 3,500 patients, with no sign...