WASHINGTON -- The FDA has approved new labeling for mifepristone (Mifeprex), also known as RU-486, the drug that is used for ending early pregnancies.
"The labeling changes include revisions to the Prescribing Information, Patient Medication Guide, Patient Agreement Form and Prescriber Agreement Form to reflect the most current clinical practices and safety and efficacy data for Mifeprex," Danco Laboratories, the drug's maker, Wednesday.
The labeling changes include:
- Changing the indication from termination of pregnancy up to 49 days to termination up to 70 days
- Lowering the first-day dosage to 200 mcg from 600 mcg
- Follow-on dosing of misoprostol is revised to 800 mcg taken 24-48 hours after mifepristone; previous recommendation was 400 mcg on day three
- Changing "Examination 14 days post Mifeprex" to "Assessment 7-14 days after Mifeprex" with the option of an additional dose of misoprostol
This labeling change "is another affirmation from the FDA that medication abortion is a safe and effective option to end an early pregnancy," said , chief medical officer of Planned Parenthood Federation of America, in a statement.
"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," McDonald-Mosley continued. "Numerous subsequent studies have demonstrated the safety and effectiveness of a regimen using a lower dosage of mifepristone that can also be used two weeks later in pregnancy, up to 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."
Mifeprex was approved by the FDA in 2000 and has been found to be about 97% effective in terminating early pregnancy, the company noted.