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- W2610218830 abstract "The scientific data on the basis on which the FDA in 1978 denied approval of depot medroxyprogesterone for use as a contraceptive are assessed. The discussion focuses on issues raised by the FDA and others raised since 1978 and is not a comprehensive review of all aspects of the drug. The benefits of DMPA and its advantages for use in some developing areas are 1st listed followed by a brief history of its development and the major evaluations conducted in the past few years by the FDA WHO Toxicology Review Panel and the Ad Hoc Consultative Panel. The reasons for the FDA decision are briefly described. Separate aspects of the controversy that are discussed include the breast cancer issue the experimentation with beagle dogs and the difference between the sensitivity to and metabolism of progestogens by beagle and human females; research on the tertogenic potential of DMPA; and the use of estrogen in conjunction with DMPA to regulate menstrual patterns. Planned studies of DMPA by several agencies are described. Issues that were not raised by the FDA include the return of fertility upon discontinuation of DMPA therapy endometrial cancer and other possible risks. The authors conclude that DMPA should be made available for use as a contraceptive provided that women receive sufficient information for informed choice of method and that research on the effects of DMPA continue." @default.
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- W2610218830 date "1981-01-01" @default.
- W2610218830 modified "2023-09-27" @default.
- W2610218830 title "Depot medroxyprogesterone acetate and health 1960-1980: what have we learned?" @default.
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