On May 16, 2005, the FDA issued an FDA Alert on the risk of Cytotec (Misoprostol) when used in labor and delivery, which states:
“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. The FDA does not approve these uses. No company has sent the FDA scientific proof that Misoprostol is safe and effective for these uses.
“There can be rare but 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.”
The FDA Alert makes it clear that 1) Cytotec should not be used for labor induction 2) BUT that, if it is to be used against this FDA recommendation, every woman receiving Cytotec for induction has the right to a fully informed consent which must include the risks listed in this FDA release. Failure to provide a woman with ALL the information regarding the side effects of Cytotec (Misoprostol) when used for the induction of labor denies the patient the right to give her a fully informed consent, and may result in serious legal exposure to those health care providers as well as needlessly jeopardizing the health of the mother and her child.
The TOFM Foundation petitioned the FDA in November 2004 to issue a more comprehensive advisory regarding the dangers of Cytotec (Misoprostol). The TOFM Foundation applauds the action of the FDA, yet there is more that must be done to alert physicians, nurses, hospitals, pharmacists and patients related to potential catastrophic outcomes that can occur when Cytotec (Misoprostol) is used for inducing labor and/or ripening the cervix.
The FDA Alert on Cytotec can be found at: www.fda.gov/cder/drug/infopage/ misoprostol/default.htm
This article appeared in Pathways to Family Wellness magazine, Issue #06.
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