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Contracept Technol Update. 1983 Mar;4(3):25-7.

FDA board investigates Depo-Provera safety.

[No authors listed]

Abstract

PIP:

For 1 week a drug company's representatives, officials from the US Food and Drug Administration (FDA), and other interested individuals debated whether Depo-Provera (medroxyprogesterone acetate or DMPA) can be safely used, but they failed to resolve the issues. "Contraceptive Technology Update" attended these hearings and interviewed witnesses to bring its readers a comprehensive report on the issues. 9 articles summarize the presentations at he hearing. The FDA public board of inquiry sought to resolve the following issues concerning Depo-Provera: in comparison with other contraceptive drugs, do the benefits outweigh the risks; do data from animal studies indicate a potential risk of breast or endometrial cancer in humans from Depo-Provera; can the human studies' data refute the risk of human cancer suggested by the animal data; are there labeling conditions and distribution controls that would permit marketing of Depo-Provera as a safe and effective drug on a limited basis; would marketing approval of Depo-Provera as a contraceptive increase the use of the drug under conditions not stipulated in the approval; does use of Depo-Provera increase the risk of teratogenic effects to a greater extent than other systemic contraceptives in the event of a failure; and is estrogen therapy likely to be prescribed for a significant number of patients using Depo-Provera. The issues raised have blocked marketing of Depo-Provera as a contraceptive in the US for a number of years. In 1968 the Upjohn Company began the lengthly process for having a drug approved for use in the US by filing with the FDA a New Drug Application (NDA) for Depo-Provera's use as a contraceptive. Although Depo-Provera has not been approved for use in the US, Upjohn manufactures the contraceptive in Belgium and France and estimates that more than a million women in 80 countries use the contraceptive. DMPA is still approved as adjunctive therapy for metastatic endometrial carcinoma and renal carcinoma. Because of that approved use, the drug has reportedly been prescribed as a contraceptive in this country, contrary to its current label indications. The FDA's obstetrics and gynecology advisory committee recommended approval of Depo-Provera in 1975, but the Public Citizen Health Research Group and some congressmen asked that the FDA not approve the drug. In 1978 the FDA notified Upjohn that its NDA would not be approved. Upjohn then requested a hearing in the form of a Public Board of Inquiry. The board held the hearing in January 1983. The controversy over Depo-Provera involves noted groups and individuals on both sides.

PMID:
12266161
[Indexed for MEDLINE]

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