![]() Cesarean rates in trials comparing misoprostol with with intravenous oxytocin (trade names Pitocin or 'Pit' and 'Syntocinon') were more variable, but not all of them found reductions in cesarean rates with misoprostol. More vaginal deliveries happened within 24 hours after administration, but cesarean rates overall did not differ between groups. The real kicker is that according to the Cochrane systematic review, misoprostol is no more effective than the FDA approved medication, PGE2 (a.k.a dinoprostone, trade names Cervidil and Prepidil). ![]() It's anybody's guess what dosage is really delivered. ![]() Getting a 25 mcg dose means cutting an unscored tablet in quarters. In any case, misoprostol is formulated in 100 mcg tablets for use as an oral ulcer medication. What about the minority? Not to mention that obstetricians may ignore recommended dosages, and even the guidelines say 'Misoprostol in higher doses (50 mcg every 6 hours) may be appropriate in some situations' (p. 387).įACT: The 'majority' of adverse outcomes is hardly reassuring. Lobbied by ACOG, the FDA rescinded the black box designation on the grounds that obstetricians were using it to induce labor, a rationale that amounts to 'but all the kids are doing it.'ĪCOG STATEMENT: 'The majority of adverse maternal and fetal outcomes associated with misoprostol therapy resulted from the use of doses greater than 25 mcg' (p. The real victims in this scenario are pregnant women who receive treatment in hospitals that will not allow the use of misoprostol' (Hale 2001, p. What actually happened was this: ACOG held that 'misoprostol is one of the most important medications in obstetrical practice. Grand multiparity also appears to be a risk factor for uterine rupture. The risk of uterine rupture increases with advancing gestational ages and with prior uterine surgery, including Cesarean delivery. There may be an increased risk of uterine tachysystole, uterine rupture, meconium passage, meconium staining of amniotic fluid, and Cesarean delivery due to uterine hyperstimulation with the use of higher doses of Cytotec including the manufactured 100 mcg tablet. Pelvic pain, retained placenta, severe genital bleeding, shock, fetal bradycardia, and fetal and maternal death have been reported. Here is an excerpt from the FDA's 2002 statement(PDF):Ī major adverse effect of the obstetrical use of Cytotec is hyperstimulation of the uterus which may progress to uterine tetany with marked impairment of uteroplacental blood flow, uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy ), or amniotic fluid embolism. The FDA removed the 'black box' designation prohibiting use in pregnant women, but it takes a much dimmer view of 'miso' than merely not claiming it is safe. 387).įACT: A reader can be forgiven for assuming from this convoluted phrasing that the FDA now approves of using misoprostol to induce labor. This labeling does not contain claims regarding the efficacy or safety of misoprostol' (p. ![]() Food and Drug Administration (FDA) for the prevention of peptic ulcers, the FDA in 2002 approved a new label on the use of misoprostol during pregnancy for cervical ripening and for the induction of labor. ![]() In some cases, of course, the fetus doesn't survive to experience long-term consequences.ĪCOG STATEMENT: 'Although misoprostol currently is approved by the U.S. 387).įACT: Well, that's the catch, isn't it? The long-term adverse health consequences to the fetus occur in the presence of fetal distress subsequent to uterine rupture - including in unscarred uteruses and with moderate doses of misoprostol - and amniotic fluid embolism. has any long-term adverse health consequences to the fetus in the absence of fetal distress. 387).įACT: None of the studies have been big enough either alone or in the aggregate to detect differences in rare, catastrophic events, a point acknowledged by a Cochrane systematic review, and it is those rare, catastrophic events that are the issue with 'miso.' And while more disasters will occur with higher doses and in women with prior cesareans, there is no 'appropriate' use of misoprostol in terms of safety.ĪCOG STATEMENT: 'No studies indicate that intrapartum exposure. a large body of published reports supporting (misoprostol's) safety and efficacy when used appropriately' (p. Still, others are also commenting, so I will focus on debunking ACOG's portrayal of misoprostol.ĪCOG STATEMENT: 'There is. Ahh, the new ACOG induction guidelines, so much to dislike, so little time. ![]()
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