Posted: July 29, 2005  1:00 a.m. Eastern  © 2005

Abortion pill warnings 'insufficient'
Pro-life groups point to deaths of 2 more women

The Food and Drug Administration's decision to strengthen language on the "morning after" abortion drug is 'insufficient' after reports that two more women have died, a pro-life advocacy group maintains.

Five women in the United States and Canada have died from septic shock after taking RU-486, or mifepristone, points out Concerned Women for America.

"The FDA allows the death toll to mount and confesses to being ‘baffled' by the deaths," said Wendy Wright, CWA's senior policy director.

Wright says the work of Brown University professor Ralph P. Miech holds a possible answer to why RU-486 causes harm to women as well as their babies.

The Annals of Pharmacotherapy will publish Miech's study in the September issue, which shows that during an abortion, mifepristone works by blocking the effects of progesterone, shutting off nutrition to the placenta and fetus.

But Miech points out the anti-progesterone effects of mifepristone also cause changes in the cervix that allow a common vaginal bacteria, called C. sordellii, to enter the cervical canal.

The bacteria thrives in the low-oxygen environment and derives nutrition from the decaying fetal tissue.

Mifepristone also disrupts the immune system, which "impairs the body's ability to fight off C. sordellii and may help spread the bacteria's toxic by-products, a combination that sometimes results in widespread septic shock," Miech says.

He points out that the women don't exhibit the usual warning signs of an infection, mainly, a fever.

Wright said last week's FDA announcement on RU-486 mentioned the deaths linked to the drug but did not release information about near-fatal adverse events.

Under the Freedom of Information Act, CWA received public documents listing more than 600 adverse events.

Two OB/GYNs who assessed the reports found they included 220 cases of hemorrhage that either were life-threatening or extremely serious, 71 of which required transfusions.

Also, 392 reports indicate a surgical procedure was done, many under emergency conditions.

"Women trust that the FDA is doing its job to protect our health," said Wright. "To continue this trust, the FDA should withdraw its approval of RU-486 before more women die.

In perhaps the best-known case, the pill was implicated in the death of 18-year-old Holly Patterson of California in 2003, who died of septic shock caused by inflammation of the uterus.

Pro-life advocates have urged Congress to pass the RU-486 Suspension and Review Act, introduced in the House and Senate.

The measure would remove the drug from the market and require review of the FDA's approval process for the drug.

In defense of its product, Danco Laboratories has stated that 200,000 American women and more than 1 million women worldwide have used the pill since it was invented in France in the 1980s.

Related stories:

Safety warnings added to abortion pill

Christian docs in battle over RU-486

FDA advisers: Make 'morning after' pill easy to get


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