FDA says two more women dead after abortion pill use

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The Food and Drug Administration disclosed yesterday that two more American women had died after taking the abortion pill, mifepristone or RU-486; bringing to seven the number of mifepristone users who have died in this country since the drug was approved here in 2000.

"At this time, we are investigating all circumstances associated with these cases and are not able to confirm the causes of death," or know whether the abortion pill was a factor, the FDA said in a "public health advisory" posted at its Web site.

Reacting to the two new deaths, Sen. Jim DeMint, South Carolina Republican, and Sen. Tom Coburn, Oklahoma Republican, both demanded that sales of mifepristone be suspended immediately.

In addition to the seven deaths potentially linked to the drug, Mr. DeMint said federal records also indicate another 600 women have experienced adverse events following its use. They include 200 women whose complications were "either life-threatening or extremely serious," Mr. DeMint said.

Mifepristone, known under the trade name of Mifeprex, is approved to end pregnancies up to 49 days after the start of a woman's last menstrual cycle. It blocks a hormone needed to sustain a pregnancy. Misoprostol, which should be taken two days after mifepristone, induces labor contractions to end a pregnancy.

In its health advisory yesterday, the FDA presented the regimen it has approved for taking mifepristone and misoprostol. Rather than taking misoprostol orally, as the FDA recommends, four California women who died inserted that drug vaginally.

Planned Parenthood Federation of America Inc. said since 2000, four of the seven women who died, including the latest two, received the pills at affiliated clinics. The organization said it will immediately stop recommending vaginal insertion of the final two tablets.

The FDA yesterday warned doctors to watch for sepsis, a potentially deadly blood infection, that previously killed four California women following medical abortions using mifepristone and misoprostol. The four all tested positive for a rare bacterial infection known as Clostridium sordelli.

"We do not know if these [two] new deaths were caused by sepsis or, if they were, if they were caused by infection with Clostridium sordelli," the FDA said in its notice. But the agency urged physicians to be on the lookout for such infections in women who have used mifepristone and misoprostol to terminate pregnancies.

Wendy Wright, president of Concerned Women for America, a pro-life organization, said she was dismayed that the FDA "did not pull" the abortion pill when it announced the two additional deaths.

"The FDA has pulled other drugs that have caused fewer deaths and even some that caused complications but no deaths. Why the double standard for this abortion drug?" Miss Wright asked. The FDA says it cannot prove mifepristone or misoprostol were to blame, but says the rate of fatal sepsis in medical abortions is approximately 1 in 100,000, which is comparable with infection risks in surgical abortions and childbirths.