Study Defends Abortion Pill Safety

Times Staff Writer

Government researchers investigating the deaths of four California women who contracted infections after taking RU-486 and another drug to induce abortion have found that the risk of infection from the controversial drug combination is “low,” according to a study released today.

The scientists also found nothing to link the deaths of the four women, who were prescribed the drugs at different clinics in Northern and Southern California between 2003 and 2005. The study, published in the New England Journal of Medicine, found that the medications came from different manufacturing lots.

“These cases demonstrate that serious infection can occur after medically induced abortion, much as it can occur after childbirth, spontaneous abortion, and surgical abortion,” the researchers wrote. “However, available data suggest that the risk of such infection is low.”


The study warned that healthcare providers and patients should be aware that the drug combination used to induce a medical abortion can lead to serious infection and death from toxic shock. It recommended further research but did not suggest that RU-486 be taken off the market, as opponents of the drug regimen have been urging.

In an editorial published along with the study, Dr. Michael F. Greene, professor of obstetrics, gynecology and reproductive biology at Harvard Medical School, warned that the deaths “have important implications both for the care of individual patients and for public policy.”

But he noted that the risk of death from infection after a medical abortion is less than 1 per 100,000, which is much lower than the death rate from carrying a child to term and about the same as that from a surgical abortion.

“As tragic as the deaths of these young, healthy women are ... regulators should keep this rare complication in perspective and not overreact to scant data by prematurely foreclosing the only approved medical option for pregnancy termination,” Greene wrote.

RU-486, which is prescribed under the brand name Mifeprex, has been controversial since it was created by French researchers a generation ago. Unlike the so-called morning-after pill, which stops pregnancy from occurring, Mifeprex blocks a hormone necessary for pregnancy to continue.

It is administered orally in a clinic or doctor’s office up to 49 days after a woman becomes pregnant. Several days later, the drug misoprostol is taken to induce contractions. The misoprostol is usually taken vaginally by the woman at home.


Holly Patterson, an 18-year-old Livermore woman, was the first American to die after taking Mifeprex and misoprostol in 2003. Shortly after her death, her family filed suit against Danco Laboratories, which distributes the drug in the United States, and called for it to be prohibited.

Last summer, the deaths of three Southern California women were reported, and state, local and federal officials began investigating. The Food and Drug Administration also sent out a public health advisory warning of the danger of infection when using Mifeprex and misoprostol. A Canadian woman also died of infection in 2001 after taking the drugs.

At least one physician challenged the journal article and editorial Wednesday.

Dr. Donna J. Harrison, who chairs the Mifeprex subcommittee of the American Assn. of Pro-Life Obstetricians and Gynecologists, believes there is a clear link between the deaths and the drug combination.

“When you have five deaths, and they’re all the same organism, that’s like lightning striking the same place five times,” said Harrison, who has been reviewing FDA files on the drug. “There’s a huge number of women who have almost died.”


The Baltimore Sun contributed to this report.