FDA advisory panel recommends approval for Depo-Provera
Contraceptive Technology Update 13(10): 159-160
1992
ISSN/ISBN: 0274-726X PMID: 12344726 Document Number: 323854
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.