Cytotec® Contraindications and Warnings

Information Source

The following quotes have been taken from the Pharmacia/Searle (manufactured by Searle) Product Information leaflet for Cytotec® (misoprostol tablets).

Indications and Usage

“Cytotec® (misoprostol) is indicated for the prevention of NSAID (nonsteroidal anti-inflammatory drugs, including asprin)-induced gastric ulcers in patients at high risk of complications from gastric ulcer, eg, the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer.”

Contraindications and Warnings

General

“Cytotec® produces uterine contractions, uterine bleeding, and expulsion of the products of conception. Miscarriages caused by Cytotec® may be incomplete.”

“Anecdotal reports, primarily from Brazil, of congenital anomalies and reports of fetal death subsequent to use of misoprostol as an abortifacient have been received.”

“Because of its abortifacient property, Cytotec® is contraindicated for use by pregnant women. Cytotec® may cause miscarriage if given to pregnant women at any time during pregnancy. Miscarriages caused by Cytotec® may be incomplete, which could lead to dangerous bleeding, hospitalization, surgery, infertility, or maternal or fetal death.”

First trimester of pregnancy

“In studies in women undergoing elective termination of pregnancy during the first trimester, Cytotec® caused partial or complete expulsion of the products of conception in 11% of the subjects and increased uterine bleeding in 41%.”

Beyond first trimester of pregnancy

“Uterine rupture has been reported when Cytotec® was administered intravaginally in pregnant women to induce labor or to induce abortion beyond the first trimester of pregnancy.”

“Uterine perforation has been reported following administration of combined vaginal-and-oral Cytotec® in pregnant women to induce abortion. In each of these reported cases, the gestational age of the pregnancies was unknown.”

“One case of amniotic fluid embolism, which resulted in maternal and fetal death, has been reported with use of misoprostol during pregnancy. Severe vaginal bleeding, retained placenta, shock, fetal bradycardia, and pelvic pain have also been reported. These women were administered misoprostol vaginally and/or orally over a range of doses.”

“Cytotec® may cause the uterus to rupture (tear) in pregnant women if it is used to bring on (induce) labor or to cause an abortion after the first trimester of pregnancy. Miscarriages or rupture of the uterus may result in severe bleeding, hospitalization, surgery, infertility or death.”

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