Are there studies with mifepristone in women under the age of 18?
The studies that FDA evaluated when it approved mifepristone included women ages 18-45. 10. What are the possible side effects of using mifepristone? Mifepristone treatment will cause vaginal bleeding. In some cases vaginal bleeding can be very heavy. In a few cases, this bleeding will need to be stopped by a surgical procedure. Other possible side effects of the treatment include diarrhea, nausea, vomiting, headache, dizziness, back pain, and tiredness. The possible side effects are described in the Medication Guide. Please read the Medication Guide. 11. What is a Medication Guide? A Medication Guide is a leaflet that contains certain FDA-approved information, written especially for patients. 12. Why did FDA develop a Medication Guide for Mifeprex? FDA determined that a Medication Guide was necessary for women to be able to use Mifeprex effectively and safely. It is important for women to be fully informed about how Mifeprex works and about its risks, as well as the need for follow-up
