FDA Strengthens Warning on RU-486

November 16, 2004 -- The death of a California woman in January after she took RU-486 to terminate a pregnancy has prompted the US Food & Drug Administration to strengthen the warning label on the drug.

The FDA is adding new information within the existing black box on the label. The added information is about "the risk of serious bacterial infections, sepsis, and bleeding and death that may occur following any termination of pregnancy, including use of Mifeprex (RU-486)."

The company that makes RU-486 in the US does "not believe the fatality should be attributed to the drug, since the coroner's report said the woman had instead taken methotrexate, a cancer medication that has been used to induce abortions," according to the New York Times

Barbara K. Hecht, Ph.D.
Frederick Hecht, M.D.
Medical Editors,

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