FDA's Action on “Abortion Pill”

News in Context |
April 5, 2016

FDA's Action on “Abortion Pill”

  1. Eleanor Bimla Schwarz, MD, MS

Mifepristone has a newly approved, evidence-based regimen.

  1. Eleanor Bimla Schwarz, MD, MS

More than 1 million U.S. women seek abortion services each year. When mifepristone (initially known as RU-486) was introduced in September 2000, many expected it to improve access to abortion services. However, hundreds of targeted restrictions on abortion provision have continued to shrink access — and 89% of U.S. counties currently have no abortion providers.

To reflect evidence-based practice, the FDA has approved the following updates to mifepristone's label:

  • On Day 1, a woman who wishes to terminate pregnancy swallows 200 mg (instead of the previous 600 mg) of mifepristone.

  • Within 24 to 48 hours, the woman places 800 µg misoprostol buccally (in the cheek pouch) for 30 minutes (instead of swallowing the pills, as previously recommended, which causes more gastrointestinal upset).

  • Sometime within the next 7 to 14 days, the woman returns to clinic to confirm successful abortion (and is no longer required to make 3 clinic visits).

The FDA now allows mifepristone use as late as 10 weeks' gestation (instead of 7 weeks).


These changes are most important in states that have curtailed access to abortion by prohibiting “off-label” use of mifepristone; elsewhere, such use has been the standard of care. While only 33% of women seek abortion services before 7 weeks' gestation, 75% seek care before 10 weeks. Despite mifepristone's impressive safety profile, U.S. clinicians who want to offer medication abortion must still register online at http://www.earlyoptionpill.com/ and dispense mifepristone instead of simply sending patients to a pharmacy (as is done in Australia [Contraception 2015; 92:186]). I hope this also will eventually change.

Editor Disclosures at Time of Publication

  • Disclosures for Eleanor Bimla Schwarz, MD, MS at time of publication Grant / Research support Veterans Health Administration; Agency for Healthcare Research and Quality Editorial boards Contraception


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