Label Changes for:

Cytotec (misoprostol) Tablets

November 2012

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

November 2012

WARNINGS

  • For hospital use only if misoprostol were to be used for cervical ripening, induction of labor, or for the treatment of serious post partum hemorrhage, which are outside of the approved indication

PRECAUTIONS

Labor and delivery
  • Uterine activity and fetal status should be monitored by trained obstetrical personnel in a hospital setting.
  • The use of Cytotec outside of its approved indication may also be associated with meconium passage, meconium staining of amniotic fluid, and Cesarean delivery. Maternal shock, maternal death, fetal bradycardia, and fetal death have also been reported with the use of misoprostol.
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