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Wash Drug Device Lett. 1977 Jan 3;9(1):2.

Controversy over Depo-Provera.

[No authors listed]

Abstract

PIP:

In response to the charge made by the Nader Health Research Group that Depo-Provera, an injectable contraceptive agent manufactured by the Upjohn Company, is hazardous, and Food and Drug Administration's (FDA) Bureau of Drugs noted that a risk/benefit evaluation of the drug was currently in progress. The Health Research Group (HRG) also expressed the fear that the FDA was about to approve the drug, and the FDA responded by stating that a bulletin had been sent to health professionals in January 1975 stressing that the drug had not received approval as a contraceptive. Initially used for treating uterine and breast cancer, it was later discovered that low doses, injected at 3 month intervals, successfully prevented pregnancy. Subsequently, the FDA's Obstetrics and Gynecology Advisory Committee recommended Depo-Provera for contraceptive use by women who wanted no more pregnancies and were unable to use other forms of contraception, but cautioned that these women should be fully informed about the risks and benefits associated with the use of the contraceptive. HRG, in charging the drug was hazardous, noted 1) since 1972 when the drug was found to produce cancer in animals, 200,000 injections have been given to women for contraceptive purposes; 2) an Upjohn study in 1972 found women who were exposed to the drug were at greater risk of cervical cancer than the general population; and 3) a National Cancer Institute study found Depo-Provera users had a 3-9 fold increased risk of cervical cancer.

PMID:
12335988
[Indexed for MEDLINE]

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