RU-486 ruled out in death linked to abortion pill


WASHINGTON -- Federal regulators studying whether the abortion pill RU-486 was responsible for the deaths of two women who took the drug ruled out one of the cases yesterday.

The Food and Drug Administration did not indicate which of the deaths had been ruled out. Cindy Summers, a spokeswoman for RU-486 manufacturer Danco Laboratories, said it was a death that took place several weeks after the abortion. The FDA is continuing to investigate the cause of the other death, which came several days after RU-486 was administered.

The agency announced last month that it was examining the two deaths and issued an alert urging doctors and patients to look for warning signs or symptoms, such as nausea, vomiting, diarrhea or abdominal pain. The agency continues urging vigilance for the symptoms, which - even without a fever - may indicate the onset of septic shock.

Four women in California and one in Canada have died from septic shock since 2001 after taking the drug. They were killed by a rare Clostridium sordellii infection, whose association with the abortion pill remains under investigation and will be the subject of a May 11 workshop involving the FDA and the federal Centers for Disease Control and Prevention.

Supporters, who say RU-486 reduces unwanted pregnancies, trumpeted the latest news as further evidence that taking the pill is safe. About 575,000 women in the United States have taken the drug since its approval in 2000. Federal researchers have reported that the risks of fatal infection are extremely low. Studies show the procedure is safer than giving birth.

"We're reassured," said Kirsten Moore, president of the Reproductive Health Technologies Group, which supports abortion rights. "But it doesn't change the fact that we need to figure out what's going on and making sure our providers and patients are well-educated about it."

Some abortion opponents have cited the deaths in demanding that the FDA restrict sales of RU-486, sold as Mifeprex. Rep. Roscoe G. Bartlett said he expects today to send a letter, signed by 46 members of Congress, to the House Republican leader urging passage of a measure that would withdraw RU-486 from the market until the drug undergoes a full review.

"We suspect the number of deaths are much more than reported," the Maryland Republican said. "Many of the women who end up in a hospital are not going to tell a doctor they had an abortion. Many are too sick to tell a doctor."

Wendy Wright of Concerned Women for America, which opposes abortion, said the risks of hemorrhaging, heart attack and inflammation of the pancreas remain despite the FDA's announcement. She urged the agency to take into account "the number of life-threatening and serious complications women have suffered, even those just short of death."

From 2000 to 2004, more than 600 serious side effects were reported to the FDA, according to a study by opponents published in February in The Annals of Pharmacotherapy.

Planned Parenthood Federation of America, the country's largest abortion provider, altered its procedures last month for administering RU-486's companion drug, misoprostol, which is given a few days after the first course of pills. Like many U.S. providers, Planned Parenthood had women inserting misoprostol vaginally. But under the changed procedures, women would take the drug orally, as the FDA

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