FDA ALERT – Risks of Use in Labor and
Delivery
This Patient Information Sheet is for
pregnant women who may receive misoprostol to soften their
cervix or induce contractions to begin labor. Misoprostol is
sometimes used to decrease blood loss after delivery of a baby.
These uses are not approved by the FDA. No company has sent the
FDA scientific proof that misoprostol is safe and effective for
these uses.
There can be serious side effects, including
a torn uterus (womb), when misoprostol is used for labor and
delivery. A torn uterus may result in severe bleeding, having
the uterus removed (hysterectomy), and death of the mother or
baby. These side effects are more likely in women who have had
previous uterine surgery, a previous Cesarean delivery
(C-section), or several previous births.
This information reflects FDA’s preliminary analysis of data
concerning this drug. FDA is considering, but has not reached a
final conclusion about, this information. FDA intends to update this
sheet when additional information or analyses become available.