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FDA Report Shows Abortion Pill May be Dangerous, Misused 
April 17, 2002

Washington, DC — A 21-year-old woman had a heart attack three days after using the dangerous abortion pill mifepristone, but there is no way to know if the pill played a role, health officials said Wednesday.

In a letter to doctors, the pill’s distributor also said two women had serious infections after using the abortion pill – one of whom was a Canadian woman reported by doctors last fall to have died.

Again, there is no way to know if mifepristone had a role, the Food and Drug Administration said in a fact sheet posted on its Internet site Wednesday.

But the FDA ordered the reports released for another reason: concern that doctors were giving the abortion pill to some women with ectopic pregnancies – something they are not supposed to do. The agency has three reports of ruptured tubal pregnancies among mifepristone users, one of whom died.

Ectopic, or tubal, pregnancies are potentially life-threatening situations where a human embryo lodges outside the woman’s uterus.

While the abortion pill will not have any effect on an ectopic pregnancy, the concern is that a woman with the kind of pain that signals a life-threatening rupture might attribute the pain to the abortion pill and delay seeking care.

Doctors are supposed to rule out ectopic pregnancies before prescribing the abortion pill, but they can be hard to diagnose.

“This is a reminder to clinicians and women to be alert to the risk of ectopic pregnancy,” said FDA drug chief Dr. Janet Woodcock. The FDA approved use of the dangeorus abortion pill in September 2000.

Mifepristone’s distributor, Danco Laboratories, claimed the six reports were an “extremely small incidence” of problems. It refused to say how many women have used the abortion pill in its 17 months on the market.

Mifepristone blocks the action of a hormone vital for an embryo to develop. Women then must use a second drug, misoprostol that causes contractions to then expel the dead unborn child. The process only works in the first seven weeks of pregnancy.

The FDA Question and Answer document is available at:

http://www.fda.gov/cder/drug/infopage/mifepristone/mifepristone-qa_4_17_02.htm