Risks to U.S. Women under Relaxed Controls

Risks to U.S. Women under Relaxed Controls

Bleeding: In U.S. trials conducted by Population Council ("PC"), 9% of women reported bleeding after 30 days and 1% were still bleeding after 60 days. "Excessive bleeding necessitated blood transfusions in four women and accounted for 25 of 27 hospitalizations (including [ER] visits), 56 of 59 surgical interventions, and 22 of 49 administrations of [IV] fluid" (I.M.Spitz, et al., "Early Pregnancy Termination with Mifepristone and Misoprostol in the United States," The New England Journal of Medicine, April 30, 1998, 338:18, 1241-47, hereinafter "NEJM"). In a Columbia University study, 20% of women bled or spotted for 5 to 6 weeks (A. Davis, et al., "Bleeding Patterns After Early Abortion with Mifepristone and Misoprostol or Manual Vacuum Aspiration," JAMWA, Supplement 2000, 141, 143).

Dr. Mark Louviere treated a Waterloo, Iowa woman who had participated in Population Council trials. Two weeks after her M/M abortion, she was taken to a hospital emergency room where Dr. Louviere found her "in obvious shock" having "lost between one-half to two-thirds of her blood volume. ... It was my clinical opinion that she would die soon. ... Without even doing the routine preparation we normally do for surgery, I realized that I had to take her immediately to surgery to save her life" (FDA Reproductive Health Drugs Advisory Committee, Hearing Transcript, July 19, 1996 at 224). The next day, he advised Planned Parenthood of Greater Iowa which in turn informed Population Council. Both organizations, however, reported "no complications," and "no adverse events ... during the course of this trial" (Id. at 19-20).

Two patients in Des Moines, Iowa trials told a TIME magazine journalist that their bleeding was "like turning a jug of water upside down" and "like a faucet was turned on. There was a steady stream of blood. I passed a golf ball size blood clot that scared me" (Sachs, "Abortion Pills on Trial," TIME, 12/5/94, p. 45).

Allergic reactions: The FDA warns that M/M abortion is contraindicated in women with known allergies to either drug. (Mifeprex Package Insert ["MPI"]). But how would one know of such an allergy in advance? Dr. Wu Shangchun, with the National Research Institute for Family Planning in Beijing reports: "The common complications of medical [drug-induced] abortion are profuse bleeding and allergy. ... Allergic reactions to mifepristone or 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. The potential for such reactions is one reason to keep clients for observation" (Wu, op. cit., at 198).

Infection: Four percent of women in PC's U.S. trials had fever, viral infection and vaginitis associated with the abortion. Ten cases of study-related endometritis (inflammation of uterine lining) also occurred. (NEJM, op cit., at 1244).

A recent review of M/M regimens around the world reports on a trial involving 2000 cases (P.W. Ashok, et al., "An Effective Regimen for Early Medical Abortion: A Report of 2000 Consecutive Cases," Human Reprod. 1998; 13:2962-2965): "The most common problems reported at follow-up were continued pain, vaginal bleeding, and offensive discharge. Antibiotics were prescribed for 5% of the 1322 women for presumed genital infection" (H. Von Hertzen, "Research on Regimens for Early Medical Abortion," JAMWA, Supplement 2000, 133, 136).

A World Health Organization study recommended giving antibiotics to women for six weeks following M/M abortions, finding an infection rate of 29.4% among women who had incomplete abortions. (World Health Organization, "Pregnancy Termination with Mifepristone and Gemeprost: A Multicenter Comparison Between Repeated Doses and a Single Dose of Mifepristone," Fertil. Steril., 56:1, 1990, 32-40).

Failure Rates: Mifepristone alone was effective for only 6% of women in PC's U.S. trials in the 48 hours preceding misoprostol administration. About half of the women studied expelled their embryo within four hours of taking misoprostol, and a total of 69% had completed abortions within 24 hours of taking misoprostol.

Many of the remaining 31% faced up to two weeks of pain, nausea and bleeding. Eight percent of women in the PC trials needed surgery, due to incomplete abortions (4.7%), ongoing pregnancies (1%), and medical reasons, usually excessive bleeding (1.6%); an additional 0.6% requested surgery. (NEJM, op. cit., at 1242).

Accuracy in determining gestational age is critical because failure rates increase dramatically after 49 days LMP—17% at 50-56 days and 23% at 57-63 days. (Id. at 1243). Untreated, incomplete abortion can result in infection, sterility and death.