FDA approves updated labeling for mifepristone

The drug is used to terminate an early pregnancy

FDA approved an updated regimen for mifepristone that now reflects the dosing regimen used in the most current clinical studies. FDA said it determined that the drug was safe and effective in accordance with the revised labeling.

Mifepristone is used to terminate an early pregnancy and the approved change lowers the dosage given from 600 mg to 200 mg, reduces the number of visits a woman must make to a physician from three to two, and lengthens the period when a woman can take the medication from 7 weeks to 10 weeks of pregnancy.

Physicians in states that permit the drug for women have for years followed this regimen, even though the label said something different. That label included clinical information from the 1990s.

Mifepristone is used in an FDA-approved regimen with misoprostol. The update also included a change in the dose and route of administration of misoprostol. FDA said 800 mcg of misoprostol should be taken buccally at a location appropriate for the patient 24 to 48 hours after taking mifepristone. Patients need to follow up with a health care provider 7 to 14 days after taking mifepristone as well.

Mifepristone is only available through a risk evaluation and mitigation (REMS) program and is not available in community pharmacies and can only be dispensed in hospitals, clinics, and medical offices, or under the supervision of a certified prescriber.

Alicia Forinash, PharmD, FCCP, BCPS, BCACP, associate professor of pharmacy practice at St. Louis College of Pharmacy, said pharmacists need to remember that the product combination is used for early pregnancy loss, which includes use for elective abortions and/or those that are medically necessary.  

Forinash said patients should know that bleeding will be heavier than menses and they may have severe cramps. If a patient has persistent heavy bleeding, her physician should be contacted.

FDA outlined certain cases when mifepristone should not be taken. These include cases when a woman has an ectopic pregnancy; an intrauterine device in place; adrenal gland issues; she is being treated with long-term corticosteroid therapy; she has known allergic reactions to mifepristone, misoprostol or similar drugs; she is taking anticoagulants; or she has inherited porphyria.

According to the Guttmacher Institute, medication-induced abortions made up roughly a quarter of all abortions in 2011, the last time figures were available.

Updated April 6, 2016