Wednesday, 30 November 2005 00:00

Abortion Pill Deaths Probed

WEDNESDAY, Nov. 30 (HealthDay News) -- The recent deaths of five young women from an otherwise rare infection within a week of taking the abortion pill Mifeprex -- also known as RU 486 -- are pitting those who say the drug is a danger to women against those who believe it is a largely safe method of terminating pregnancy.

Reporting in the Dec. 1 issue of the New England Journal of Medicine, experts at the U.S. Centers for Disease Control and Prevention outlined four U.S. cases (the fifth case involved a Canadian woman) where otherwise healthy young women contracted a Clostridium sordellii bacterial infection.

In each case, the women became very ill within days of their medical abortion and died of toxic shock syndrome related to the infection.

The families of three of those four women are suing the drug's maker, Danco Laboratories. And last week, the The New York Times quoted anonymous sources at the U.S. Food and Drug Administration as saying the agency would convene a special scientific meeting on the deaths early next year, in cooperation with the CDC.

Complicating matters is the fact that experts have yet to find a causative link between the use of Mifeprex (mifepristone) -- the so-called "abortion pill" that is usually taken with a second drug, misoprostol -- and C. sordellii infection.

"That's what's bugging everybody -- there's no obvious pathophysiological link between these medications and this, or any other, infection," said Dr. Michael F. Greene, a professor of obstetrics, gynecology and reproductive biology at Harvard Medical School and director of obstetrics at Massachusetts General Hospital in Boston. Greene is also the author of a journal editorial commenting on the CDC report.

In the fall of 2000, FDA officials first approved the use of Mifeprex for use in the early (less than seven weeks gestation) termination of pregnancy, after 54 months of deliberation and review. The original approval included a "black-box" warning advising prescribers of a potential risk for incomplete abortion and complications such as ectopic pregnancy and septic shock, associated with the drug's use.

According to Danco, Mifeprex has been used in more than 500,000 abortions since it first gained U.S. approval five years ago.

"Mifeprex is what's called an 'anti-progesterone' -- it blocks progesterone receptors and basically starves off a pregnancy," Greene explained. However, when the drug is used alone, materials linked to conception can remain in the uterus, posing a risk of infection. That's why doctors prescribe misoprostol -- which causes the uterus to contract and safely expel this material -- whenever they offer women Mifeprex.

In all four cases under CDC review, the women's wombs were found to be free of this type of material on autopsy, further puzzling the experts as to the source of the infections.

Serious C. sordellii infection, especially in the uterus, is extremely rare, so to have five known fatal infections occurring over the past three years suggests a real link to the women's use of Mifeprex, Greene said. "It would [otherwise] certainly be a very unusual coincidence of circumstances," he said.

Another layer of mystery comes from the fact that all four U.S. deaths occurred in California. But the FDA tested lots of the drug distributed in that state and found no sign that they had been contaminated in any way.

All of the women, who were otherwise young and healthy -- died under similar circumstances: The bacterium gained access to the uterus, where it flourished and entered the bloodstream. C. sordellii infection causes nausea, diarrhea and weakness, but does not always trigger fever.

Unfortunately, Greene said, "most physicians consider fever to be a cardinal sign of infection, so by the time most women presented and