Abstract

Although the injectable contraceptive Depo-Provera (medroxyprogesterone acetate) is currently being used by 1.25 million women worldwide and is available commercially in over 60 countries approval for marketing in the U.S. has not been granted after 12 years of debate. Possibly the final installment in what has become a controversy will probably take place later this year when a special FDA board of inquiry meets to consider the issue. More is at stake than the licensing of a particular drug. The Depo-Provera case represents a clash of political social and ethical values. The author reviews the drugs risks and benefits to support the conclusion that the FDA should continue to withhold approval of Depo-Provera as a contraceptive and that Congress should continue the current ban on exporting drugs not licensed for use in the U.S. Although Depo-Provera is a contraceptive that works is convenient to use simple to administer and does not have any immediate life-threatening side effects risks include disturbed menstrual patterns weight gain delayed return of fertility after discontinuance or possible permanent infertility birth defects and carcinogenicity. Studies with laboratory animals have related the appearance of carcinomas with high doses of the drug. Perhaps the most accurate conclusion is that Depo-Provera does present a certain degree of risk in some respects higher and in many respects unknown that is not present in other approved contraceptive methods. Other factors considered include the claim that Depo-Provera is intended for poor women or 2d-class citizens; protection against abuse; exporting of the drug to the Third World; and ethical problems. It is concluded that rather than change the current legislation to make Depo-Provera available for export U.S. policy ought to be to encourage and support the kind of broad social change that will ultimately make Depo-Provera unnecessary in the Third World.

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