EXECUTIVE SUMMARY
The Food and Drug Administration has approved new and updated labeling for the medication abortion drug mifepristone (Mifeprex, Danco Laboratories) to reflect the most current clinical practices and safety and efficacy data.
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The drug’s new label reduces the size of the initial dose to 200 mg and extends the window for taking it to 70 days since the first day of a woman’s last menstrual period.
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The new labeling also allows the second drug in the medication abortion regimen, misoprostol, to be taken “at a location appropriate for the patient.”
The Food and Drug Administration (FDA) has approved new and updated labeling for the medication abortion drug mifepristone (Mifeprex, Danco Laboratories, New York City) to reflect the most current clinical practices and safety and efficacy data. The drug’s new label reduces the size of the initial dose and extends the window for taking it to 70 days since the first day of a woman’s last menstrual period. The new labeling also allows the second drug in the medication abortion regimen, misoprostol, to be taken “at a location appropriate for the patient.”
The new mifepristone dosing regimen is:
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On day one, 200 mg of Mifeprex (one tablet) is taken by mouth.
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At 24-48 hours after taking Mifeprex, 800 mcg (four tablets) of misoprostol is taken buccally (in the cheek pouch) at a location appropriate for the patient.
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About 7-14 days after taking Mifeprex, patients follow up with the healthcare provider.
The old labeling had allowed for the mifepristone/misoprostol regimen to be used to up to 49 days after a woman’s last menstrual period. It had called for a higher dose of mifepristone (600 mg [three tablets]) as the initial dose, and a lower dose of misoprostol (400 mcg [two tablets]) on day three. The old labeling also called for a patient examination by the provider 14 days post mifepristone.
Medication abortion accounted for 23% of all nonhospital abortions and 36% of abortions before nine weeks’ gestation, according to the latest data.1
Label and safe practice
Women’s health advocates have applauded the new labeling and say that the new label reflects up-to-date scientific evidence on provision of medication abortion. The new label lowers the recommended dosage of one of the two drugs used, extends the timeframe for when a woman can take the pill, and reduces the number of visits a woman must make to her provider, notes the Association of Reproductive Health Professionals.
Following the FDA’s announcement, Mark DeFrancesco, MD, MBA, president of the American Congress of Obstetricians and Gynecologists, said in a statement, “The evidence-based regimen for medication abortion has been shown to improve efficacy, reduce adverse effects, and even lower the cost of medication abortion. And by allowing more qualified health care providers to prescribe and administer mifepristone, and removing the in-person follow-up appointment, the updated label will also make medication abortion accessible to more women, including previously underserved and rural women.”
Until the March 2016 regulatory action, the regimen outlined on labeling approved by the FDA was based on clinical trials completed in the mid-1990s. Subsequent research has demonstrated the safety and effectiveness of a regimen using a lower dosage of mifepristone that also can be used two weeks later in pregnancy, up to 70 days since a woman’s last menstrual period.2
Raegan McDonald-Mosley, MD, MPH, chief medical officer of the New York City-based Planned Parenthood Federation of America, says, “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. 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 healthcare providers who want to give our patients the highest quality care.”
Put labeling into practice
There have been several bills introduced in the past few years to restrict medication abortion; recently, lawmakers have introduced similar bills in Iowa and New Hampshire.
Lawmakers in Ohio and Texas have passed laws that require mifepristone to be provided in accordance with the old FDA labeling, while North Dakota and Oklahoma have enacted laws requiring the use of the FDA protocol. The Ohio and Texas laws have been blocked by courts and are not in effect. An Arizona state court judge in 2016 blocked a state law that mandated physicians to follow the old FDA-approved labeling when administering “any medication, drug, or substance” to induce an abortion. However, Arizona’s House of Representatives recently has approved a bill requiring doctors to follow the old FDA labeling when it comes to medication abortion.
Because providers in the United States already have been providing evidence-based care, which the new label now recognizes, actual practice will not change, notes Vicki Saporta, president and chief executive officer of the Washington, DC-based National Abortion Federation.
“What will change is that politicians can no longer deny women access to this safe and effective method of early abortion care by insisting on an outdated regimen,” said Saporta in an announcement following the label change. “We hope the new label changes will soon allow women to access medical abortion care in states where anti-choice restrictions have made this evidence-based care unavailable.”
REFERENCES
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Jones RK, Jerman J. Abortion incidence and service availability in the United States, 2011. Perspect Sex Reprod Health 2014; 46(1):3-14.
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Gatter M, Cleland K, Nucatola DL. Efficacy and safety of medical abortion using mifepristone and buccal misoprostol through 63 days. Contraception 2015; 91(4):269-273.
