FDA Reaffirms Safety of Mifepristone, Approves New Label for Medication Abortion

New Label Mirrors Planned Parenthood’s Existing Protocols

New Label Means that Medication Abortion Can Once Again be Provided According to Evidence Based Medicine in All 50 States

WASHINGTON, DC --- Today, the U.S. Food and Drug Administration (FDA) approved 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 for Family Planning.  The FDA’s approval of the new label is based on substantial evidence demonstrating that medication abortion is safe for virtually all women.

“First and foremost, this is another affirmation from the FDA that medication abortion is a safe and effective option to end 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,” said Raegan McDonald-Mosley, Chief Medical Officer of Planned Parenthood Federation of America.  

Mifepristone, also known as medication abortion or “the abortion pill” (formerly known as RU-486), is an antiprogesterone drug that blocks receptors of progesterone, a key hormone in the establishment and maintenance of pregnancy.  Used in combination with a prostaglandin such as misoprostol, mifepristone induces abortion when administered in early pregnancy, providing women with an alternative to aspiration (suction or surgical) abortion.  A medication abortion is different than emergency contraception, or “the morning after pill,” which prevents a pregnancy from occurring.  

An overwhelming majority of women who choose mifepristone for medication abortion are satisfied with the method.  One study found that 97 percent of women would recommend the method to a friend.  Additionally, 91 percent of the women reported that they would choose the mifepristone regimen again if they had to have another abortion.

Until today, the regimen outlined on mifepristone’s final printing label approved by the FDA was based on clinical trials completed in the mid-1990s.  Numerous subsequent studies have demonstrated the safety and effectiveness of a regimen using a lower dosage of mifepristone that can also be used three weeks later in pregnancy,  through 70 days since a woman’s last menstrual period. This new regimen has been recognized by the American Medical Association and the American College of Obstetricians and Gynecologists as “superior” to the regimen on the previous FDA-approved label.

“Since Planned Parenthood’s medical standards are constantly-evolving with the latest clinical research findings, we have actually had the protocols approved today in place at Planned Parenthood for some time,” Dr. McDonald-Mosley continued.  “But given the restrictions on medication abortion enacted at the state level in recent years, updating the label to reflect best medical practice represents a significant step forward for science, for women, and for health care providers who want to give our patients the highest quality care.”

The benefit of this announcement will be most immediately felt by women and providers in Ohio, Texas and North Dakota --- states where laws are in effect requiring that medication abortion be provided according to the regimen outlined on mifepristone’s label (similar restrictions on medication abortion passed but have been blocked by court order in Arizona, Arkansas, and Oklahoma). While it is widely accepted standard medical practice for medicines to be used in different protocols than those upon which the FDA issues approval, these laws compelled health care providers to use an outdated, inferior and less effective regimen.

Setting aside other restrictive state laws that interfere with the doctor-patient relationship and the provision of abortion in these states, the FDA’s approval of the new Mifeprex label means that medication abortion can once again be provided everywhere in the U.S. in accordance with what research shows is safest and most effective.  However, the Arizona legislature is on the verge of amending state law to require that providers follow the regimen outlined on the old label for medication abortion, regardless of scientific evidence and the new FDA-approved label.

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