Word: fda
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Dates: during 1960-1969
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...side effect that responsible medical men have charged against the pills is that they may increase the risk of thrombophlebitis-formation of blood clots, usually in leg veins. A number of women have died of clotting disorders while taking Enovid, but a special committee of experts named by the FDA could find no proof that Enovid was to blame. Many women who have never taken the pills, and who rarely take any drugs, suffer from thrombophlebitis. But nobody knows how the number of such cases compares with that among women taking Enovid. The committee of experts concluded that the pills...
...length of time that a woman can continue taking the pills safely is still uncertain. FDA has set the recommended limit for Enovid and Ortho-Novum at four years, and of Enovid-E at three years, though it is holding the newest pills to two years for the present. There has been some speculation that long-term use of the pills might postpone the menopause and leave women fertile far beyond nature's normal age limit of 45 to 50. But women who were nearing the menopause when they started on the pills several years ago have since...
Split Schedule. All the oral contraceptives so far approved by FDA contain, in addition to their principal ingredient of the synthetic, progestin, a minute amount of another synthetic hormone, estrogen. This fulfills some of the roles of the estrogen that a woman normally secretes generously during the first part of her menstrual cycle, and it serves to prevent spotting or break-through bleeding in the middle part of the cycle...
...them to be taken on a divided schedule called "sequential therapy." This system requires taking an estrogen pill for 16 days, then a progestin pill for five days. Its proponents claim that it comes closer to the natural physiological hormone cycle. Mead, Johnson & Co. already has an application before FDA asking approval of sequential-therapy pills compounded of ingredients bought from British Drug Houses, Ltd. And Indianapolis' Eli Lilly & Co., working with Syntex, is on the same tack. Michigan's Upjohn Co. is preparing a pill it calls Provest, and Pennsylvania's Wyeth Laboratories are testing still...
...served on the faculty of Yale and Stanford medical schools before he went to G.W. as a full professor and chairman of a new department of preventive medicine and community health. An experienced administrator, he is also a tough negotiator. He set his own terms for taking the FDA job, and got them. He, and all the doctors on his staff, are to have some time reserved for research or teaching. This, Dr. Sadusk believes, will ensure his being able to attract men of medical distinction...