FDA Adds to Abortion Pill Safety Warning

A pill used to terminate pregnancy that was implicated in the death of a California woman will add warnings linking RU-486 to the risk of serious bacterial infection.

Holly Patterson died Sept. 17, 2003, of septic shock caused by inflammation of the uterus. The 18-year-old died weeks after taking RU-486 to terminate an unplanned pregnancy. Antiabortion activists seized upon her death in their campaign against these pills, including Mifeprex, a product of Danco Laboratories.

The Food and Drug Administration 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 said Monday that the drug’s warning would be expanded, with added information about rare but potentially life-threatening complications such as serious bacterial infections and bleeding, which can follow any abortion.

Since the drug was approved, the agency has received reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured and death.

Women who have taken the drug should contact a doctor immediately if they suffer fever, abdominal pain and heavy bleeding, a consumer guide says.

Danco Laboratories did not immediately return a phone call seeking comment.