By Rebecca Oas, Ph.D. and Susan Yoshihara, Ph.D. | November 16, 2017
WASHINGTON, D.C., November 17, (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 recommends its use.
Alain Michel Ceretti, president of a group of French patients’ associations, told The Lancet that 94% of Cytotec prescriptions in France are off-label. Additionally, many doctors administer the drug vaginally rather than orally, contrary to its indications, and the recommended dosage requires splitting the tablet into eighths, increasing the risk of overdose. Other misoprostol brands sold in France are much more expensive, and Ceretti suggested that doctors prescribe the more expensive version, dispense Cytotec, and “pocket the difference.”
The day after French newspaper Le Monde reported the story, they published an article hailing Cytotec as a “miracle drug” in Latin America, where abortion is largely illegal and medical abortion drugs are imported secretly and sold on the black market. Abortion groups also responded, speculating that Pfizer has declined to re-label the drug and might opt to stop producing it at all “because they are ‘uncomfortable’ with abortion.” They further expressed hope that “Pfizer limits the damage to France.”
The double standard for poor women was not mentioned in the articles, nor the fact that if doctors in France are misusing Cytotec in the context of off-label use, there are patient advocacy groups and formal mechanisms to ensure accountability and the removal of dangerous drugs from the marketplace. Women harmed in developing countries by black-market abortion drugs, administered with cover from WHO guidances, have no such recourse and are unlikely to see payouts from the pharmaceutical companies who manufacture them—unlike the victims in France.
There has been no formal response from WHO, who has been heavily lobbied to add more and not fewer indications for misoprostol in its Essential Medicines List, often by organizations that promote its use for both postpartum hemorrhage and abortion. In 2009, the WHO issued a statement explaining its decision not to list misoprostol for postpartum hemorrhage, only to reverse its position two years later, after extensive advocacy by abortion-promoting groups including Gynuity, Population Services International, and Women Deliver.
The inclusion of misoprostol as an essential medicine ensures its widespread availability, including in contexts where abortion is illegal. In 2012, WHO published a technical guidance on “safe abortion” offering instructions to perform abortions using misoprostol alone or with mifepristone—including dangerous late-term abortions.