Medical abortion update: Death sparks questions on abortion pill

Review facts, counseling strategies to affirm safety

A young woman recently died after undergoing a medical abortion. Patients are anxious and asking questions. How do you respond?

"Medical abortion is very safe and effective," states Vanessa Cullins, MD, MPH, vice president of medical affairs at the New York City-based Planned Parenthood Federation of America. "Medical abortion has been used by more than 200,000 women in the United States, and if you look specifically at the Planned Parenthood Federation of America experience, it has been provided very safely, very effectively for more than 58,000 women."

Holly Patterson, an 18-year-old Livermore, CA, woman, sought health care services at a San Francisco Planned Parenthood Golden Gate health center on Sept. 10, 2003. According to news reports, Patterson received mifepristone from Planned Parenthood. Some accounts say Patterson had severe pain and bleeding on Sept. 14, went to a Bay Area hospital, and was sent home with painkillers. She was back at the hospital on Sept. 16 and died the next day.1 The cause of death is unknown. Planned Parenthood declined further comment on the specifics of the case, citing confidentiality of the doctor-patient relationship.

Rank the risks

What are some talking points that you can use with patients when discussing medical abortion? While every medical procedure involves risk, medical abortion using mifepristone has a track record of safety and effectiveness. Marketed as Mifeprex by Danco Laboratories of New York City, the drug was approved by the Food and Drug Administration (FDA) in September 2000 after an extensive and rigorous scientific screening process and following more than a decade of use in Europe.

Mifepristone has been used successfully by more than 200,000 women in the United States and by more than a million women worldwide. To put risks into perspective, consider the following information, used by Planned Parenthood in discussing the recent incident:2

Two deaths of women who had taken mifepristone have been recorded in North America since its introduction. One death involved an undiagnosed, untreated ectopic pregnancy, which mifepristone does not treat. She died as a result of a hemorrhage due to a ruptured ectopic pregnancy. The other stemmed from an extremely rare bacterial infection. No causal relationship has been established between the drug and the conditions in either of the cases. Of the approximately 3,000 patients involved in trials of the mifepristone/misoprostol regimen, only one case of ectopic pregnancy was reported. The incidence of ectopic pregnancy among patients seeking early surgical abortion at less than six weeks’ gestation is 6.7 per 1,000.3 Confirmed or suspected ectopic pregnancy is a contraindication for use of mifepristone and should be ruled out prior to initiating drug treatment.

No deaths have taken place as a result of the use of mifepristone. In 1991, a woman in France died from cardiac arrest as a result of using the drug sulprostone, an intramuscular, injectable prostaglandin that was once used in place of misoprostol. Sulprostone is not available in the United States, and it is no longer used in France.4

Even if the death linked to the infection was the result of having had a medical abortion, the North American rate of death from mifepristone medical abortion would be very low: one per 250,000 medical abortions or four per 1 million medical abortions, according to Planned Parenthood. In comparison:

• The risk of death each year for men and women who drive automobiles is 169 per 1 million automobile drivers.5

• The risk of dying from continuing a pregnancy beyond 20 weeks is 107 per million live births.6

• The risk of dying from a surgical abortion performed up to eight weeks is one per 1 million surgical abortions, and two per 1 million surgical abortions performed between nine and 10 weeks.7

Any woman seeking abortion should be fully counseled about all options, including surgical and medical abortion, delivery, and adoption. Women may choose medical abortion because they fear a surgical procedure.

Review side effects

Preparing women for the normal range of side effects that are expected with medical abortion is a critical component of patient counseling and education, states Vicki Saporta, executive director of the Washington, DC-based National Abortion Federation (NAF).

"As a general guiding principle, when women are adequately prepared regarding the steps of the process and what to expect, they are more comfortable with the process and reassured about what is normal and what would warrant a follow-up call to their provider," she says.

Expected side effects of the mifepristone/misoprostol regimen include:

• Gastrointestinal symptoms.

Women experiencing a medical abortion commonly report nausea, vomiting, and diarrhea. Most gastrointestinal symptoms can be managed with reassurance; occasionally, an anti-nausea medication may be needed for persistent vomiting.

Crampy abdominal (uterine) pain.

Most women will experience crampy abdominal pain. Reassurance, a heating pad, a nonsteroidal anti-inflammatory drug, or a mild narcotic such as acetaminophen with codeine should be sufficient to ease the discomfort.

Other misoprostol-related side effects.

PMisoprostol is associated with other prosta-glandin-like side effects such as headache, chills, and fever may occur, which are usually self-limited.

Bleeding.

Vaginal bleeding is necessary for a complete medical abortion. Although the amount of blood loss for surgical and medical terminations is fairly comparable, women undergoing a medical procedure observe the bleeding. Bleeding under the medical regimen is heaviest when products of conception are passed within the immediate three to six hours after using misoprostol. Women should be instructed to contact their health care provider on call if they saturate four or more maxi-sanitary napkins over two consecutive hours. For most women, light bleeding persists for nine to 21 days, and about 8% of women continue bleeding for as much as one month.8

The most serious complication for mifepristone/misoprostol abortion is excessive bleeding. Excessive bleeding requiring surgical intervention ranges from 0.4% to 2.6%.9,10 Providers should be skilled to perform an aspiration curettage for an incomplete abortion or have a formal arrangement for such care.

Women who have excessive bleeding from a medical abortion present similarly to women with an incomplete spontaneous abortion. The cervix is typically soft and dilated, and the embryo has partially detached or been expelled. Manual vacuum aspiration with a 60 cc Ipas hand-held syringe and a 6 mm or 7 mm flexible cannula should be sufficient to empty the uterus and provide adequate hemostatis.7

NAF has developed several patient education resources for women seeking information about medical abortion with mifepristone/misoprostol, including an on-line "Woman’s Information Guide" at www.earlyoptions.org/w_guide.html and a patient education video and a brochure that compare medical and surgical abortion and describe what to expect during a medical abortion, says Saporta. 

The organization has not yet finalized its 2004 training schedule, but providers who are interested in obtaining training in medical abortion should visit the organization’s web site, www.prochoice.org, states Saporta. The organization offers its on-line continuing medical education program at www.earlyoptions.org/online_cme/default.asp.

References

1. Kolata G. Death at 18 spurs debate over a pill for abortion. The New York Times, Sept. 24, 2003:A24.

2. Planned Parenthood Federation of America. Talking Points for Planned Parenthood Clients. New York City; Oct. 2, 2003.

3. National Abortion Federation. Early Options: A Provider’s Guide to Medical Abortion. Washington, DC; accessed at: www.earlyoptions.org/online_cme/m2complications.asp#4.

4. Planned Parenthood Federation of America. Mifepris-tone: Expanding Women’s Options for Early Abortion. New York City; accessed at: www.plannedparenthood.org/library/ABORTION/Mif_fact.html.

5. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology. 17th revised ed. New York City: Ardent Media; 1998.

6. Chang J, Elam-Evans LD, Berg CJ, et al. Pregnancy-Related Mortality Surveillance — United States, 1991-1999. In: Surveillance Summaries, Feb. 21, 2003. MMWR 2003; 52(SS-2):1-8.

7. Whitehead S, Bartlett L, Herndon J, et al. Abortion-Related Mortality: United States, 1988-1997. Presented at the 2002 annual meeting of the National Abortion Federation. San Jose, CA; April, 2002.

8. Schaff E, Mawson J. Gauging the effectiveness of mifepristone and misoprostol. Contraceptive Technology Reports 2001; 6.

9. Ashok PW, Penney GC, Flett GM, et al. An effective regimen for early medical abortion: A report of 2000 consecutive cases. Hum Reprod 1998; 13:2,962-2,965.

10. Spitz IM, Bardin CS, Benton L, et al. Early pregnancy termination with mifepristone and misoprostol in the United States. New Eng J Med 1998; 338:1,241-1,247.

Resource

For more information on medical abortion, contact:

National Abortion Federation, 1755 Massachusetts Ave. N.W., Suite 600, Washington, DC 20036. Telephone: (202) 667-5881. Fax: (202) 667-5890. E-mail: earlyoptions@prochoice.org. The patient video, "Making Your Choice, A Woman’s Guide to Medical Abortion," is available in English and Spanish. Cost is $15 for federation members and $20 for nonmembers. The patient education brochure, available in Chinese, Croatian, English, Russian, Spanish, and Vietnamese, is $5 for 20 (both members and nonmembers); $10 for 50, members, and $14 for 50, nonmember. Contact the federation at (202) 667-5881 for bulk order pricing.