hen my obstetrician couldn’t detect a fetal heartbeat during my 9th week of pregnancy, he cleared his schedule. His assistant worked through lunch. They booked an operating room, lined up an anesthesiologist, coordinated insurance approvals, and scheduled a dilation and evacuation procedure for the following morning. It was over by noon. I was able to start healing, emotionally and physically.
I was lucky to get such fast and efficient care. It doesn’t work that way for countless women across the country.
Every year in the U.S., more than 500,000 women miscarry pregnancies before 12 weeks of gestation. Many must travel long distances to reach medical facilities that can perform effective and painless procedures to remove the expired fetus and extra uterine tissue. And many women have difficulty paying for these procedures, which are even more expensive for those with underlying health problems.
Only two non-surgical options exist for women experiencing miscarriage: allow tissue from the pregnancy to pass out of the body naturally, or take one or more doses of a medication called misoprostol to speed the process. Both of these approaches can cause significant vaginal bleeding, nausea, and cramping. Both can take several weeks or more, and require repeat doctors’ visits and ultrasounds. And even after a month of discomfort and blood loss, up to 20 percent of women will still have pregnancy tissue lingering in the uterus and require a dilation and evacuation. The unpredictability and prolonged nature of existing non-invasive treatments can increase the emotional and physical toll of an already traumatic experience.
The results of a landmark clinical trial, published this month in the New England Journal of Medicine, paves the way for a more efficient and effective medical option. A bicoastal team of researchers randomized 300 women experiencing first-trimester miscarriages to a dose of misoprostol or to a combination of misoprostol plus mifepristone. The combination lead to completion of the miscarriage in 84 percent of women within two days, compared to 67 percent among women who got misoprostol alone. The most common significant side effect was transient vaginal bleeding.
The American College of Obstetricians and Gynecologists has announced it is reviewing these findings to determine whether to update its clinical guidance and policy position on caring for women with miscarriage. The success rate of this novel two-drug regimen would be a game-changer for women of childbearing age in the United States and abroad — if they could get access to it.
Mifepristone is also known as RU-486 or the abortion pill. The Food and Drug Administration approved it for use in the United States in September 2000. Yet despite multiple studies over the last 17 years that have confirmed the safety of mifepristone, the FDA severely restricts its use.
Retail pharmacies are prohibited from carrying mifepristone, even behind the counter. It can be dispensed only by specialized physicians who have undergone extra training and certification. Patients must be able to travel to registered facilities to use it, and even then they must sign an FDA-approved patient agreement before treatment.
These restrictions, known as Risk Evaluation and Mitigation Strategy (REMS), exist so the FDA can regulate medications that carry “serious safety concerns.” They are designed to provide extra safeguards when package inserts aren’t enough. Other medications under REMS guidelines include an injectable antipsychotic that can cause patients to lapse into a coma and an acne medicine that can cause severe birth defects when taken by a woman who is pregnant. In contrast, the side effects of mifepristone include vaginal bleeding, dizziness, and cramping.
The law governing the use of REMS restrictions states that safety measures must be in keeping with a medication’s potential harm, and must not place unnecessary burdens on access. The current restrictions on mifepristone violate both of those stipulations.
Critics say that easing restrictions on mifepristone would increase its use for abortion. They may be correct. But given that abortion is legal in the United States, and that mifepristone has been FDA-approved for use in abortions for 17 years, the only potential downside of its increased availability is political. Not medical.
Women’s health experts have repeatedly cited the lack of scientific evidence for REMS restrictions on mifepristone, and have repeatedly called for the FDA to withdraw them. By showing that this medication is safe and effective in medically managed miscarriages, the combination trial reported in the New England Journal of Medicine cements the case for increased availability of mifepristone.
Women across the country deserve timely access to treatment when they miscarry. I was able to grieve the life I had hoped to bring into the world without weeks of physical suffering. If we do not remove barriers to this efficient, effective, and safe medical regimen, we break the central tenet of medical practice: do no harm.
Dorothy Novick, M.D., is a pediatrician in Philadelphia.