Rebecca Oas, Ph.D. and Susan Yoshihara
WASHINGTON, D.C., November 17, 2o17 (C-Fam) — France announced its intention to withdraw the drug Cytotec from its market by March 2018 after reports of hemorrhaging, ruptured uteruses, and birth defects from off-label use for labor induction and abortion. Abortion advocates responded with concern that the decision could make abortion less accessible in France, and diminish its use for illegal abortions in developing countries.
In 1988, U.S.-based pharmaceutical company Pfizer marketed misoprostol under the name Cytotec as a treatment for gastric ulcers. It carried warnings that it should not be used by pregnant women, as it also caused uterine contractions. Over the years, off-label uses of misoprostol eclipsed its original purpose. The World Health Organization (WHO) first listed it on its 2005 Essential Medicines List and added new indications for it in 2009, 2011, and 2015 — none of which pertain to ulcers. Instead, it is listed for management of miscarriage, prevention and treatment of postpartum hemorrhage, induction of labor, and — where legal and culturally appropriate — for abortion, with the drug mifepristone, under “close medical supervision,” though such supervision is often unavailable in the same regions WHO
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