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Cytotec: Labor
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The effect of Cytotec on later growth, development, and functional maturation of the child when Cytotec is used for cervical ripening or induction of labor has not been established. Information on Cytotec's effect on the need for forceps delivery or other intervention is unknown.
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The purpose of this letter is to remind you that Cytotec administration by any route is contraindicated in women who are pregnant because it can cause abortion. Cytotec is not approved for the induction of labor or abortion.
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The authors greatly confuse the reader by lumping together all uses of Cytotec during pregnancy: first trimester medical abortion, induction of labor, postpartum hemorrhage. Each of these indications has very different data and should never be combined. "Two hundred studies involving a total of more than 16,000 women" is falsely inflating the data and is most misleading. The number of studies on Cytotec labor induction is far fewer. Most of them are not randomized experimental trials, and all of them, trials included, are too small to have sufficient statistical power for the less common but catastrophic risks such as uterine rupture, perinatal mortality and maternal mortality.
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Searle has not conducted research concerning the use of Cytotec for cervical ripening prior to termination of pregnancy or for induction of labor, nor does Searle intend to study or support these uses. Therefore, Searle is unable to provide complete risk information for Cytotec when it is used for such purposes. In addition to the known and unknown acute risks to the mother and fetus, the effect of Cytotec on the later growth, development and functional maturation of the child when Cytotec is used for induction of labor or cervical ripening has not been established.
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IN A SURVEY OF 14 HOSPITALS in Santa Clara County and the Bay Area, 10 reported that their facility has a protocol in place for the use of Cytotec in labor induction. While some hospital personnel were much more forthcoming than others, there were areas of general agreement in the guidelines--especially since hospital groups often share information.
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[I]t is women who have had Caesareans who are at greatest risk from Cytotec. An article published in 1999 in the American Journal of Obstetrics and Gynecology reported that uterine rupture occurred in five of 89 women with previous Caesarean delivery whose labors were induced with Cytotec -- about one out of 16, a shockingly high figure, representing a more than 28-fold increase over those who did not have Cytotec induction for VBAC (vaginal birth after Caesarean). One of the five ruptures ... caused a baby to die.
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