ACOG committe opinion. New U.S. Food and Drug Administration labeling on Cytotec (misoprostol) use and pregnancy. Number 283, May 2003.

On April 17, 2002, the U.S. Food and Drug Administration approved a new label for the use of Cytotec (misprostol) during pregnancy. The new labeling does not contain claims regarding the efficacy and/or safety of Cytotec when it is used for cervical ripening for the induction of labor nor does it stipulate doses or dosing intervals. Therefore, the Committee on Obstetric Practice reminds Fellows that this agent should be used as previously recommended.