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The Washington Post and other media outlets have identified the Shanghai Hua Lian Pharmaceutical Co. Ltd. as the manufacturer for the American market. (China is one of the world's best markets for the abortion pill.) But Hua Lian has had manufacturing problems. U.S. officials have found that the state-owned company was responsible for mislabeling other drugs it manufactured and for allowing potentially harmful impurities to contaminate one of its herbal products. To date, there have been no reports that its Mifepristone has been contaminated or mislabeled.

Catherine Weiss, director of the Reproductive Freedom Project for the American Civil Liberties Union (ACLU), disputes suggestions that the abortion pill is unsafe for women or that its FDA review was inadequate. "This drug was reviewed as thoroughly as or more thoroughly than any drug approved by the FDA," Weiss says. "Yes, there are risks, but there are risks with aspirin."

Mifepristone, marketed as "the early option pill," acts on a pregnant woman's body by blocking progesterone, a key female hormone also critical to a healthy pregnancy. But Mifepristone is actually part of a two-drug abortion regimen. Any woman seeking to use Mifepristone first visits a doctor's office or clinic, where she will receive counseling and a usage guide. While there, she takes 600 milligrams of the drug. She returns two days later and, if still pregnant, takes 400 micrograms of Misoprostol, a prostaglandin approved for the treatment of peptic ulcers that, according to the FDA, "causes the uterine muscles to contract and end the pregnancy." About two weeks later, the woman returns to see if her pregnancy has, in fact, been ended.

Last August, the drug company G. D. Searle, maker of Misoprostol (under the trade name Cytotec), released a letter reminding health-care providers that its drug "is not approved for the induction of labor or abortion." According to Mother Jones magazine, Misoprostol has been linked to 30 incidents of uterine rupture, including the deaths of eight unborn children, in the last three years.

Mifepristone does have a high success rate, but it is not foolproof. In the recent American clinical trials, an abortion was completed in 92.1 percent of the cases (compared to 95.5 percent in two French trials); and 7.9 percent of the women needed some kind of surgical intervention, including 1.2 percent who experienced heavy bleeding, 4.7 percent who had incomplete abortions, and 1 percent who continued their pregnancies (albeit with a higher probability of birth defects).

The FDA notes that "most women will experience some side effects," including cramping, nausea, vomiting, and diarrhea. Bleeding and spotting usually last between 9 and 16 days. Eight percent of women, however, will bleed for more than 30 days. Of the 1,800 women in the earlier French trials, two required blood transfusions. An estimated 1 percent will require surgery to stop bleeding. The regimen will not work for women whose pregnancies implant outside the uterus (about 2 percent of all pregnancies). The efficacy of Mifepristone drops sharply after 49 days, so pregnancy duration must be dated precisely.

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June 11 2001, Vol. 45, No. 8