Will the Mifeprex labeling be changed?
The labeling has not changed at this time. As with all drugs, FDA and the manufacturer continue to work to evaluate case reports and other information to determine if changes are needed to the labeling. • Why are physicians using misoprostol “off-label,” in other words, using misoprostol vaginally at different doses? There are published studies of the use of mifepristone with vaginal administration of misoprostol for abortion. The misoprostol doses used in these studies are higher than those described in the Mifeprex labeling. These studies were not part of the clinical trials that FDA reviewed when FDA approved mifepristone, nor have they been submitted for review, therefore, FDA has had no opportunity to evaluate the safety or efficacy of this regimen. Because physicians exercise their judgment in prescribing what they feel is best for the patient, they may decide to use an “off-label” regimen, rather than the approved regimen. In order to change or add a new dosing regimen to the la
