Abortion Information - http://www.roevwade.org (Underlines are mine—Debbie)

National Conference of Catholic Bishops on RU 486's Risks

[This article written by Susan E. Willis, an assistant director of the National Conference of Catholic Bishops Secretariat for Pro-Life Activities.]

Washington, DC -- The FDA's decision to approve use of RU-486 in the United States is oxymoronic. If this two-drug abortion regimen -- known as

mifepristone/misoprostol -- is really so "safe and effective" that it should be available to American women, why did it put so many restrictions

on its use? It's not as if mifepristone is a potentially life-saving drug, for which one might accept a high level of harmful side effects and risks.

Quite the opposite is true.

The only purpose of the drug is to kill a developing child up to 35 days after fertilization. (To put that in context, we know from embryology

texts that the child's heartbeat begins at 18-22 days after fertilization.) There is no lack of means or places to get an abortion in the United States, so it's peculiar that the agency would proceed with approval despite the risks. There's only one explanation for the action: Their hope is that, in the hands of primary care providers, the abortion drug combination will "mainstream" abortion and end the public debate over abortion forever.

Proposed FDA regulations leaked to the press in June reflected a serious and well-grounded concern about the risks to women who take the drug. The

FDA now appears to have relaxed the restrictions to the point where they will no longer protect most women, and they now ensure that doctors other

than abortionists might prescribe these drugs.

Any prescribing doctor must register with distributor of the drug and agree to meet its qualifications for use and comply with its guidelines,

such as assuring the pregnancy is under 49 days duration and ruling out ectopic pregnancies, providing surgical intervention for incomplete

abortion or severe bleeding (or having arrangements with an abortion provider to do so), assuring patient access to medical facilities for any

necessary blood transfusions and resuscitation. Unfortunately, no observation period is required after misoprostol is administered. A 14-day

follow-up visit is required. The prescriber must report all ongoing pregnancies, serious adverse events, hospitalizations, and transfusions.

But even with these precautions in place, even ruling out women whose age or health advise against mifepristone use, the two-drug regimen poses

serious risks. About 8 percent of drug-induced abortions fail, requiring surgical abortion as a backup. Infection, sterility and death can result

from undiagnosed incomplete abortion.

Excessive bleeding is common. Nine percent of women in U.S. trials bled for more than 30 days; one percent bled for over 60 days. Four women in

U.S. trials (of about 2,000) required blood transfusions; 25 women were treated in emergency rooms or hospitalized for complications.

An investigator for the National Research Institute for Family Planning in Beijing discussed China's experience with mifepristone in a recent issue

of the Journal of the American Medical Women's Association: " The common complications ... are profuse bleeding and allergy ... Allergic reactions

to mifepristone and misoprostol were not uncommon, manifesting in facial edema, skin rash and itching, numbness of feet and hands, and even a

serious case of allergic shock," he wrote. "The potential for such reactions is one reason to keep clients for observation."

He adds that mifepristone/misoprostol abortions are falling into disfavor among staff at larger hospitals in China: "The staffs were too busy to

handle the procedure (more counseling, more visits and observation), and they also have to manage the referred cases with serious side effects and

complications."

Will the FDA decision to "privatize" abortion change the debate forever? I think not. Responsible doctors, who do not now perform abortions, will

think twice before using mifepristone because the risks are not worth taking. Others, less scrupulous, will prescribe the drug. Because U.S.

women seldom return to abortion clinics for follow-up, there may be far more women harmed by this drug combination than even the FDA anticipates.

This is a deadly drug, providing more reason, not less, to oppose abortion as a solution to "unplanned" pregnancy.