U.S. Government Accountability Office Reaffirms Safety of Mifepristone and 2016 Label for Medication Abortion
For Immediate Release: March 29, 2018
WASHINGTON D.C. - Today, the U.S. Government Accountability Office reaffirmed the safety of mifepristone and the 2016 label for medication abortion in a report for the U.S. Food and Drug Administration. This follows the Food and Drug Administration (FDA) 2016 approval of a new label for Mifeprex (mifepristone), one of the medicines used in a medication abortion. The new label updates the protocol for medication abortion so it reflects the most common evidence-based protocols recommended by Planned Parenthood, the World Health Organization, the American Medical Association, the American College of Obstetricians and Gynecologists, and the Society of Family Planning. The FDA’s approval of the new label was based on substantial evidence demonstrating that medication abortion is safe for virtually all women.
Today’s report follows a landmark study from the National Academies of Sciences, Engineering, and Medicine confirming that abortions in the United are safe and have few complications. The study also found that medically unnecessary restrictions on abortion make abortion less safe. Medication abortion is an extremely safe, effective method of ending an early pregnancy. American women have been safely and legally using medication abortion for well over a decade. In fact, one in four women decides to use this method if it is an available option. And medical studies have shown that medication abortion is just as safe as surgical abortion — which has over a 99 percent safety record according to data from the CDC and others.
Statement from Dr. Gillian Dean, Senior Director of Medical Services at Planned Parenthood Federation of America:
This report is another affirmation that medication abortion is a safe and effective option for ending an early pregnancy. Studies show medication abortion has a 99 percent safety record, and that medication abortion is up to 98 percent effective in ending an early pregnancy. The results underscore that the 2016 label change was rooted in evidence-based medicine.
Medication abortion gives people the option of what may feel like a more private method of ending a pregnancy in a setting where they feel most comfortable, with support throughout the process by a medical professional. The patient is told how the process works, the range of normal symptoms to expect, and the warning signs to look out for. The patient also receives resources, including a medication guide and a telephone number to call anytime 24/7 if they have any questions or concerns.
In the extremely unlikely event that a patient experiences a serious complication from an abortion and requires hospital-based care, the high-quality, experienced physicians and nurses who work at Planned Parenthood have detailed systems in place to ensure that a patient gets care quickly.
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Planned Parenthood is the nation’s leading provider and advocate of high-quality, affordable health care for women, men, and young people, as well as the nation’s largest provider of sex education. With more than 600 health centers across the country, Planned Parenthood organizations serve all patients with care and compassion, with respect and without judgment. Through health centers, programs in schools and communities, and online resources, Planned Parenthood is a trusted source of reliable health information that allows people to make informed health decisions. We do all this because we care passionately about helping people lead healthier lives.