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Abortion Pill Deaths Probed

Battle continues over Mifeprex's safety after rare cases of fatal infection

WEDNESDAY, Nov. 30, 2005 (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 were recognized to be sick, they were practically dead."

According to the Times, the four California women who died were Holly Patterson, 18, of Livermore; Vivian Tran, 22, of Costa Mesa; Chanelle Bryant, 22, of Pasadena; and Orlane Shevlin, 34, of Los Angeles. The deaths occurred between Sept. 17, 2003, and May 24, 2005.

Greene said that while the deaths are "tragic," the mifepristone-misoprostol regimen remains very safe. Surgical abortions performed at seven weeks of gestation or less carry an estimated risk of maternal mortality of about one in 1,000,000, he said. Risks for death by using Mifeprex-misoprostol are higher -- about one in 100,000 -- but still very low, he said.

"Rather than be alarmed, I would rather people be aware of this risk," Greene said.

Not everyone agrees with his assessment, however.

Wendy Wright, executive vice president of the conservative group Concerned Women for America, believes Mifeprex to be a dangerous drug that is being prescribed without proper oversight.

"This is creating a health hazard for women," she said. "The drug's owner [Danco] has only one product, so it has no incentive to pull the drug from the market. That's why the FDA must act in the best interest of women's health by pulling this drug from the market."

She took issue with Greene's editorial, saying "it is clearly reflecting an opinion and leaves out key information." According to Wright, many complications and deaths linked to both surgical and medical abortions go unreported, so the actual number of deaths linked to the abortion pill could be much higher.

"The death is [often] not attributed to the abortion," she said, "the death certificate will just say hemorrhaging, for example."

But Dr. Scott Spear, a professor of pediatrics at the University of Wisconsin, and chairman of Planned Parenthood's national medical committee, contended that any young, healthy woman who died in these circumstances "would likely come to the attention of the CDC."

"Particularly given the fact that this is something that's now on the radar for clinicians -- they're not likely to ignore any such deaths, and would very likely have them fully investigated and reported to the CDC," he said.

According to Spear, the safety of Mifeprex-misoprostol "still seems to be very, very high for the vast majority of women."

But Wright said many prescribers aren't following FDA-recommended guidelines on the proper use of the two-drug regimen. Most notably, many women are being advised to administer misoprostol vaginally (the FDA approves only oral use of the drug). Among the many questions facing the CDC and FDA is whether this route of administration might somehow encourage C. sordellii infection.

Spear said it was "inappropriate" to comment on any causative link between use of the medical abortion drug and the recent deaths. "That's why we await the CDC [panel] findings," he said.

Attempts to contact Danco Laboratories, based in New York City, were unsuccessful. However, in a press release issued July 18, the company said there is "no evidence that Mifeprex and misoprostol present a special risk of infection."

"Danco is committed to providing updated safety information about this early option for women," the company's director of marketing and public affairs, Cynthia Summers, said in the statement. "We will be sending a Dear Doctor Letter soon to all providers of Mifeprex, as well as to all emergency room directors, to ensure that they are aware of this new information."

Greene said education will be key in preventing more deaths.

More information

For more on Mifeprex, visit the U.S. Food and Drug Administration.

SOURCES: Michael F. Greene, M.D., director, obstetrics, Massachusetts General Hospital, and professor, obstetrics, gynecology and reproductive biology, Harvard Medical School, Boston; Wendy Wright, executive vice president, Concerned Women for America, Washington, D.C.; Scott Spear, M.D., associate professor, pediatrics, University of Wisconsin, and chairman, National Medical Committee, Planned Parenthood Federation of America, Washington, D.C.; Dec. 1, 2005, New England Journal of Medicine; Nov. 23, 2005, New York Times; July 18, 2005, statement, Danco Laboratories, New York City
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