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Title: FDA advisory panel recommends approval for Depo-Provera. Journal: Contracept Technol Update; 1992 Oct; 13(10):159-60. PubMed ID: 12344726. Abstract: The fertility and maternal health drugs advisory committee of the US Food and Drug Administration recently voted to recommended approval of the use of Depo-Provera, manufactured by Upjohn Co. in Kalamazoo, MI. Depo-Provera is a hormonal contraceptive which contains depot-medroxyprogesterone acetate to be injected intramuscular every 3 months. Currently, it is approved by the FDA only for treatment of endometrial or renal cancer. Experts agree that Depo-Provera is an excellent drug and FDA approval is expected by the end of the year. The FDA denied Upjohn's application for approval of Depo-Provera for contraception in 1978, but since then studies have refuted the link between cancer and Depo-Provera. The committee also recommended post marketing studies to assess the problem. The FDA is also reviewing new data from New Zealand showing a possible increased risk of osteoporosis associated with longterm use of the drug. The FDA advisory committee recommended an informed consent document for women who would use Depo-Provera to advise about the risk of bone loss. The FDA is also reviewing new data from Thailand showing a link between low birth weight babies and Depo-Provera uses during pregnancy that could necessity a warning label to rule out pregnancy before administering Depo-Provera.[Abstract] [Full Text] [Related] [New Search]