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  1. 1
    077765

    FDA gives final approval to Depo amid concerns over safety, cost and coercion.

    WASHINGTON MEMO. 1992 Nov 12; (17):2-3.

    In October 1992, the US Food and Drug Administration (FDA) approved Depo-Provera for contraceptive use thus increasing the number of available contraceptives to women. Yet USAID has distributed it through its family planning programs in developing countries for many years. It has been available in the US since 1969 for noncontraceptive purposes such as endometrial cancer treatment. More than >30 million women around the world have used it to prevent conception. Today about 9 million women in 90 countries use it. A reason FDA did not approve Depo-Provera is that some studies revealed a link between it and breast tumors and cervical cancer in animals. More recent research conducted by WHO shows no connection with cervical cancer or ovarian cancer. In fact, it demonstrates Depo-Provera may protect against endometrial cancer. Yet it does indicate an insignificant increased risk of breast cancer in younger women. Some research suggests Depo-Provera may decrease bone density leading to osteoporosis and may increase the risk of having a low birth weight infant if the child is conceived before an injection. Evidence exists that it may lead to longer delays in becoming pregnant than other forms of contraception. Still 70% do conceive within 12 months after the last injection. Each Depo-Provera injection delivers a progestin in a water-based solution over 12 weeks resulting in suppressed ovulation. Its failure rate is <.5%/year, so Depo-Provera is one of the most effective reversible contraceptive available. The most common side effects are menstrual changes and weight gain (5-15 lbs.). Some contraindications include pregnancy, heart or liver disease, and breast cancer. As of November 1992, the FDA had not announced the cost or whether there would be a reduced price for family planning and public health clinics. Women's health and rights advocates plan on monitoring introduction of Depo-Provera to make sure that women have received comprehensive information and were not coerced to use it.
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  2. 2
    010601

    Depo-Provera debate revs up at FDA.

    Sun M

    Science. 1982 Jul 30; 217(4558):424-8.

    The record of the U.S. Food and Drug Administration's (USFDA) actions regarding Depo-Provera, a medroxyprogesterone acetate, as an injectable contraceptive and the international implications are reviewed. In September 1982 a special panel of scientists began deliberations to recommend whether Depo-Provera should be approved for use as an injectable contraceptive. The U.S. Agency for International Development (USAID) has been asked by developing countries to furnish the drug but will not export drugs that are not approved by USFDA. More than 80 countries have approved the drug. Advocates for USFDA approval include the Upjohn Company (manufacturer of the drug), World Health Organization, International Planned Parenthood Federation, Population Crisis Committee, and the American College of Obstetrics and Gynecology. The opposition includes the Health Research Group affiliated with Ralph Nader, the National Women's Health Network, and several right-to-life groups. Hesitation by USFDA is related to laboratory animal studies which suggest that Depo-Provera is a potential human carcinogen. Upjohn conducted a 7 year study with 16 beagles and a 10 year study with Rhesus monkeys; both of the test animals developed more tumors than the controls. Questions were raised about using the animals since the response of these two species to the drug and the human response are not necessarily comparable. Limited approval has been recommended twice by expert advisory committees in 1974 and 1975, but USFDA refused both times. It is suspected that Korea, Taiwan, Egypt, Jordan, and Yemen reversed their approval as a result of the latest USFDA rejection. This final decision will have major economic and social implications and will assume international importance.
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