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FDA Says 2 More Women Have Died After Taking Abortion Pill
Agency Is Investigating; 7 Fatalities Now Tied to RU-486

By Marc Kaufman
Washington Post Staff Writer
Saturday, March 18, 2006

The Food and Drug Administration reported yesterday that two more women have died after taking the RU-486 abortion pill, bringing to seven the number of fatalities associated with the drug since it was approved for use in 2000.

The agency said that it was investigating the new reports, provided by the manufacturer of the drug, but so far was not able to confirm any cause of death. In four earlier fatalities of California women who had undergone medical abortions, the victims died of a form of blood poisoning caused by Clostridium sordellii , a common but rarely fatal bacterium.

Opponents of abortion quickly described the FDA advisory as another reason to ban the abortion pill, sold as Mifeprex.

"RU-486 is a deadly drug that is killing pregnant women," Sen. Jim DeMint (R-S.C.), who has co-sponsored a bill to take the drug off the market pending a review, said in a statement. "This drug should never have been approved, and it must be suspended immediately."

But supporters said that the pill, which has been used worldwide for years, remains safe.

"To put this in context . . . 560,000 medication abortions have occurred in the United States. We know of seven reported deaths of women who had medication abortions in North America," Vanessa Cullins, vice president for medical affairs of the Planned Parenthood Federation of America, said in a statement. "At this time, none of those deaths have been directly attributed" to the abortion pill, she said.

Though commonly known as RU-486, this medical abortion actually entails taking two pills. The first, an antiprogestin, binds itself to the wall of the uterus, triggering the shedding of the uterine wall and not allowing the embryo to become implanted. One or two days later, the woman takes another drug -- misoprostol -- that causes her cervix to soften and dilate so the embryo can be expelled.

As a precaution, Cullins said, Planned Parenthood is changing its policy on how medical abortions should be administered. In the past, many women received misoprostol vaginally, although the FDA had never reviewed or approved that method. Vaginal use is considered to be more effective and has fewer side effects, but Cullins said that her organization would no longer recommend that method.

In its advisory, the FDA pointedly said that the safety and effectiveness of vaginal use of the second drug "has not been established." It also said that providers of medical abortion and emergency-room staffs should investigate the possibility of blood poisoning whenever women who have taken the drugs come in complaining of nausea, vomiting or weakness unassociated with fever or other signs of infection.

The FDA said yesterday that it did not know whether the clostridium bacteria played any role in the most recent deaths, but the agency did establish that it was present in four earlier fatalities. One other death related to medical abortion was in a woman who had an ectopic pregnancy -- a condition where RU-486 is not considered appropriate.

The issue of clostridium infection will be discussed at a public workshop in May hosted by the FDA and the Centers for Disease Control and Prevention. The bacterium has been associated with a small number of deaths and more hospitalizations involving both medical abortions and skin grafts.

The agency's handling of the seven deaths of women who had undergone medical abortion was criticized by opponents of the drug.

"The FDA has pulled other drugs that have caused fewer deaths and less severe complications than RU-486," Wendy Wright, president of Concerned Women for America, said in a statement. "Why the double-standard for an abortion drug that is now linked to the deaths of seven healthy women and over 800 other reported complications?"

Opponents of medical abortion filed a citizen's petition with the FDA soon after the drug was approved for use, but the FDA has never acted on it. In addition, Rep. Roscoe G. Bartlett (R-Md.) introduced a bill in 2003 -- called Holly's Law, after Holly Patterson, an 18-year-old California woman who died following a medical abortion -- that would ban use of RU-486. The bill has 79 co-sponsors.

Bartlett said yesterday that the maker of Mifeprex, Danco Laboratories LLC, should pull the drug from the market. If it refuses, he said, the FDA should force its withdrawal.

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