It is important to notice, as I mentioned before, the safety profile of misoprostol is not different at all from the safety profile of oxytocin. What I am trying to convey is that both drugs can cause amniotic fluid embolism, labor hyperstimulation and fetal problems when are not used appropriately. Amniotic fluid embolism, although devastating, is very rare (1:20,000 to 1:30,000 livebirths in the US), and it is not any more frequent with misoprostol than with oxytocin.

Since November 1999, ACOG has followed this issue very closely, and has issued at least three Committee Opinions regarding misoprostol (See Committee Opinions Numbers 228, 248, and 283). In the latter one, it refers to FDA labeling changes regarding the use of this medication for labor induction (See http://www.fda.gov/medwatch/safety/2002/cytotec_changes.PDF) and the ACOG position remains stable, within the standard use as proposed in the ACOG Committee Opinion #228, and re-emphasized on #283, the use of misoprostol for labor induction is an adequate, proven and efficacious approach where indicated.

One last comment about this issue. The idea that the use of medications, any medication with any degree of FDA approval, is devoid of risks is misleading. Best efforts are made, by all the organizations involved, in provide patients with the safest medications possible. Unfortunately, nothing is free of risks: Acetyl salicylic acid (aspirin), possibly the oldest drug in the market, has a list of uncommon side-effects that can affect different organs and systems such as severe hemorrhagic and coagulation disorders, Reye’s Syndrome, hepatitis, rhabdomyolysis and a large number of other rare entities

Thank you