Abortion Pill Is Safe in First Year of Use in U.S., Proponents Say

One year after its introduction in the United States, the abortion pill is proving to be highly effective and safe for the vast majority of women, abortion proponents say.

Planned Parenthood Federation, a leading advocate of the pill marketed as Mifeprex, said it has achieved a success rate of 99% among about 5,200 patients nationwide. Other doctors who provide the abortion pill to patients also report they have experienced high success rates with few clinical problems.

The success rate reported by Planned Parenthood is higher than the 92% to 95% effectiveness rate reported when the abortion pill was tested in U.S. research studies prior to gaining marketing approval from the Food and Drug Administration. The FDA has received few reports of adverse effects, according to an agency spokesperson.

The experience to date runs counter to warnings from abortion opponents prior to the drug’s approval that women would suffer adverse health effects or even die from medical abortions.

“The kinds of side effects we’re seeing are largely anticipated,” says Dr. Richard U. Hausknecht, medical director of Danco Laboratories, which manufactures Mifeprex. “The number of adverse events has been significantly lower than the number of adverse events reported in the original [U.S.] clinical trials.”

That is somewhat surprising, Hausknecht notes, because clinical trials, where patients are closely monitored, generally produce somewhat better outcomes than when a treatment is released to the general population.

In one exception, more women have had pelvic infections following medical abortion than was seen during clinical trials, says Hausknecht, a New York ob-gyn. Infections are uncommon and can be treated with antibiotics, he says.

The pill, whose scientific name is mifepristone and which is known as RU-486 in Europe, is typically available to women less than seven weeks’ pregnant. Two days after taking Mifeprex, women return for a second drug, misoprostol, which causes contractions and the expulsion of the fetus.

Mifeprex has only been in widespread use in the U.S. for about six months, however. And acceptance of the method as safe and effective may be clouded by the death last month of a Canadian woman who was undergoing a medical abortion. That incident led the Canadian government to temporarily halt its Mifeprex clinical trials pending an investigation.

The woman died of a rare bacterial infection, but it is not yet known whether the death was related to the abortion, according to the Population Council, a nonprofit organization that helped attain U.S. approval of the abortion pill. An FDA official says the agency will review the case.

A new report from the Kaiser Family Foundation, a nonprofit health care philanthropy, found that few doctors outside of traditional abortion clinics are offering Mifeprex. But the survey shows that 16% of gynecologists and 7% of general practice doctors say they are likely to begin offering it within the next year.

Bolstered by the ease of the method, some doctors are now studying variations of the abortion pill regimen that could lower costs and make the procedure more convenient for women. Some clinics, for instance, are already giving women a lower dose of Mifeprex and allowing them to take the misoprostol at home.

Opponents of abortion warn, however, that women could be harmed by the second drug, misoprostol. The fact that few private practice doctors are offering the abortion pill is evidence that physicians have concerns about its safety--particularly that of misoprostol, says Edward Szymkowiak, a spokesman for the American Life League, a Stafford, Va.-based organization that opposes abortion.

While obstetricians have recently debated the safety of using misoprostol to induce labor among women with full-term pregnancies, there is no evidence that the drug is harmful as part of the abortion regimen, abortion proponents say.