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RU-486 was touted as an easy solution to an unplanned pregnancy, but it turns out that even abortion advocates shy away from the drug that can have serious complications.
A 21-year-old woman had a heart attack three days after using the abortion pill Mifepristone, but there is no way to know if the pill played a role, say health officials. In a letter to doctors, the pill’s distributor also said two women had serious infections after using RU-486 - one of whom was a Canadian woman reported by doctors to have died in the fall of 2002.
There is no way to know if Mifepristone had a role in any of the noted problems, the Food and Drug Administration said in a fact sheet posted on its web site. But the FDA ordered the reports released for another reason: concern that doctors were giving RU-486 to some women with ectopic pregnancies, something they are not supposed to do. The FDA has three reports of ruptured tubal pregnancies among RU-486 users, one of whom died. The letter stresses that doctors need to follow the recommended guidelines for administering the drug and in particular, to perform ultrasound to see if an ectopic pregnancy has occurred, in which case RU-486 should not be used.
Ectopic or tubal pregnancies are potentially life-threatening situations where the newly fertilized 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 help.
Doctors are supposed to rule out ectopic pregnancies before prescribing RU-486, 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.
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. RU-486 has a safe track record in more than a decade of overseas use; and Planned Parenthood clinics in this country reported that, of 12,700 “medical” abortions done in one year, there was not one major complication.
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 expel the deed unborn baby. The process is only to be legally used the first seven weeks of pregnancy.
The FDA also released changes in the labeling of Misoprostol (or Cytotec, manufactured by Pharmacia) which specify that the drug may be used late in pregnancy to induce labor and delivery. The new labeling warns that during late pregnancy, rupture of the uterus can occur in women who receive high doses, or in those who have had prior uterine surgery, or five or more pregnancies.
