FDA To Issue Abortion Drug Warning
10/19/2005 5:12:13 PM
An abortion pill implicated in the death of an 18-year-old California woman last fall will add new warnings linking RU-486 (news - web sites) to the risk of serious bacterial infection. Holly Patterson died Sept. 17, 2003, of septic shock caused by inflammation of the uterus. The teen died weeks after taking RU-486 to terminate an unplanned pregnancy. Anti-abortion activists seized upon her death in their campaign against these pills, including Danco Laboratories' product, Mifeprex.
The Food and Drug Administration (news - web sites) approved Mifeprex in 2000 to terminate pregnancy up to 49 days after the beginning of the last menstrual cycle. The drug blocks progesterone, a hormone required to sustain a pregnancy. When followed by another medicine, misoprostol, Mifeprex terminates the pregnancy.
Mifeprex already carries a black box warning, the agency's most strident alert, to highlight other safety concerns. The FDA (news - web sites) said Monday that the drug's black box warning will expand, adding information about the such rare but potentially life-threatening complications as serious bacterial infections and bleeding that can follow any abortion, including one induced by Mifeprex.
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