A letter has been circulated by the manufacturer of misoprostol (Cytotec®) to remind health care providers that misoprostol administration by any route is contraindicated in women who are pregnant because it can cause abortion.
Misoprostol is indicated for the prevention of gastric ulcers induced by use of nonsteroidal anti-inflammatory drugs (NSAIDs) in patients at high risk of complications from gastric ulcer.
The uterotonic effect of misoprostol is an inherent property of prostaglandin E1, of which misoprostol is a stable, orally active, synthetic analogue. Serious adverse events reported following off-label use in pregnant women include maternal or foetal death, uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or salpingo-oophorectomy, amniotic fluid embolism, severe vaginal bleeding, retained placenta, shock, foetal bradycardia and pelvic pain.
Reference: Letter from Searle, USA, dated 23 August 2000. http://www.fda.gov/medwatch