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  • Title: The Food and Drug Administration and medroxyprogesterone acetate. What are the issues?
    Author: Rosenfield A, Maine D, Rochat R, Shelton J, Hatcher RA.
    Journal: JAMA; 1983 Jun 03; 249(21):2922-8. PubMed ID: 6221125.
    Abstract:
    In 1978, the Food and Drug Administration denied approval of the three-month injectable contraceptive depot medroxyprogesterone acetate for use in the United States. This decision goes against the advice of the FDA's own scientific advisory panels, as well as the rulings of the World Health Organization and the drug regulation institutions of more than 70 developed and developing countries. In response to protest from the manufacturer of depot medroxyprogesterone acetate and from many health professionals, the FDA took the unusual step of scheduling a public board of inquiry to review its decision in January 1983. Reviewing the scientific literature on the risks and benefits of depot medroxyprogesterone acetate, we find no reason to deny depot medroxyprogesterone acetate approval, provided that studies of its possible side effects are continued and that women use it only after having made an informed choice between this and other methods of contraception. This article reviews scientific evidence of the risks and benefits of depot medroxyprogesterone acetate (DMPA) and argues that it should be approved for contraceptive use in the US provided that studies of its possible side effects are continued and that women use it only after informed choice. DMPA has the highest use effectiveness of any reversible method and is the only available injectable that is effective for 3 months. It has few potentially harmful metabolic side effects and does not appear to suppress lactation. There appear to be few absolute contraindications to its use except pregnancy. Its benefits have made it popular in different settings; its manufacturer, the Upjohn Company, reports that about 1/2 of DMPA use occurs in developed countries. The World Health Organization Toxicology Review Panel, the US Agency for International Development Ad Hoc Consultative Panel, US Food and Drug Administration scientific advisory panels, and other qualified groups have concluded that the ban on contraceptive use of DMPA is unwarranted. Studies finding an increased incidence of mammary tumors in beagle dogs are of questionable applicability to women because of the different reaction of beagles to progestogens. Other studies have not shown increased incidence of breast disease in DMPA users. Available data do not show that DMPA poses more of a threat of fetal malformation than do other hormonal contraceptives if taken during pregnancy. The use of exogenous estrogens to control heavy bleeding in users is rarely needed; there is no evidence of a permanent impairment of fertility after DMPA use and any association between DMPA use and endometrial cancer remains questionable.
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