July 20, 2005

2 More Women Die After Abortion Pills

By GARDINER HARRIS
http://www.nytimes.com/2005/07/20/politics/20abort.html?th=&oref=login&emc=th&pagewanted=print  (must register to view original article)

WASHINGTON, July 19 - Two more California women have died after taking abortion pills, and federal drug regulators say they suspect bacterial infections as the cause. As a result, the drug's label will be changed to warn women and doctors to watch out for signs of an unusual infection that is not always accompanied by fever, the Food and Drug Administration announced Tuesday.

Five women in the United States have now died after taking abortion pills; four of them most likely suffered lethal bacterial infections, said Dr. Steven Galson, director of the agency's center for drugs.

Still, the risks of death from infection for users of the pill is roughly one in 100,000 uses - similar to the risks of death from infection after surgical abortions or childbirth, Dr. Galson said.

"There are no alarm bells going off because of this rate, but we are watching it closely," he said.

Dr. Galson emphasized that the agency did not know whether these infections were caused by the use of Mifeprex, the abortion medicine also known as misoprostol or RU-486.

The latest warnings about Mifeprex will be included in a "black box" warning that is already on the drug's label. Such warnings are the highest level of alert by the drug agency.

Dr. Cynthia Summers, a spokeswoman for Danco Laboratories, Mifeprex's maker, said she did not think the medicine caused bacterial infections. "This same infection has been reported after childbirth and other gynecological situations," Dr. Summers said.

Still, the company thought it was important to warn doctors and patients to watch for the signs of such an infection, she said, "so that this does not happen again."

"If you're feeling lousy more than 24 hours after taking misoprostol, even if you're not in terrible pain and don't have a fever, you should call your doctor," Dr. Summers said.

Wendy Wright, senior policy director for Concerned Women of America, a conservative women's group, said news of the latest death proved that label changes would not make the drug safe.

"Changing the label the last time clearly didn't help the latest woman who died," Ms. Wright said. "Sadly, people who support RU-486 apparently believe the risk of death is preferable to having a child."

Elizabeth Toledo, a spokeswoman for Planned Parenthood Federation of America, whose clinics provide many of the nation's abortions, said, "Medication abortion is extremely safe and effective."

For two of the women who died, samples have proved that the bacterium involved was Clostridium sordellii, Dr. Galson said. Infection with this bacteria can cause nausea, vomiting, diarrhea and weakness but does not necessarily lead to abdominal pain and infection.

Doctors who suspect an infection in one of their patients should start them on antibiotics immediately, the F.D.A. advised. It also advised against prescribing all medication-abortion patients an antibiotic just to be sure, since the risks of such prescriptions outweigh the rare risk of an infection, Dr. Galson said.