Abortion pill's risk minimal, study says

WASHINGTON — Government investigators studying the deaths of four California women who took the RU-486 abortion pill played down the risks to other users Wednesday and said the bacterial infection that caused the deaths wasn't particular to women taking the drug.

In an article in The New England Journal of Medicine, the investigators described the risk of the Clostridium sordellii infection as "low" and said it could occur after taking the pill, undergoing a surgical abortion or giving birth.

Their findings angered opponents of the abortion pill who have been urging federal drug regulators to suspend sales as a grave threat to women's health.

Supporters, who increasingly have worried the Food and Drug Administration might buckle under political pressure and restrict access to the drug, welcomed the report.

They got an additional boost from an associate editor of the medical journal, who in an editorial emphasized the "small" risk to users.

"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," wrote Dr. Michael Greene, a Harvard Medical School professor of obstetrics, gynecology and reproductive biology.

Since RU-486 was approved five years ago, more than a half-million women have taken the drug, marketed as Mifeprex. Use of the pill, along with a companion drug taken a few days later, is called a medical abortion because surgery isn't required.

Opponents have seized on the four deaths in California since 2003 — and a fifth in Canada, in 2001 — to demand the FDA order an end to sales.

Dr. Donna Harrison of the American Association of Pro-Life Obstetricians and Gynecologists, blames the deaths on medical abortion. "When you have five deaths, and they're all the same organism, that's like lightning striking the same place five times," she said.

Harrison has been reviewing 840 reports of adverse events filed with the FDA in connection with Mifeprex. She asserted that the risks from taking the drug are higher than thought because many serious problems go unreported.

Dr. Cynthia Summers, spokeswoman for Danco Laboratories, the manufacturer of Mifeprex, praised the articles for highlighting the relative safety of the regimen, pointing out that the authors found it was safer than childbirth.

"Fewer than two out of 1,000 women treated with Mifeprex have any adverse event reported to Danco," she said in an e-mail. "The vast majority of these adverse events are not serious, not emergencies and are not unexpected."

Scientists at the Centers for Disease Control and Prevention, along with health officials in California, began their investigation last summer after learning of one death. They identified three other deaths in the United States associated with medical abortion, but did not find any others that followed use of the abortion pill.

They did find nine other Clostridium sordellii deaths unrelated to the procedure. Eight followed childbirth, and one was not related to pregnancy.

Some doctors and pill opponents assert medical abortion caused the fatal infection by weakening the body's immune system. The investigators said in their article that more study was needed to determine whether the procedure or other factors caused the deaths.