Cytotec, this anti-ulcer used for delivery soon forbidden

Published on 04/28/2024 07:25

Cytotec, a drug on the market and indicated to treat ulcers, will be withdrawn from the market in March 2018. The reason? Frequently hijacked to trigger term deliveries, it poses serious health risks for mothers and their children.

In France, a large number of deliveries and voluntary interruptions of pregnancies have been initiated by Cytotec for several years.

However, this drug, marketed by the laboratory Pfizer France since 1987, has a marketing authorization (AMM) only for gastroenterological indications, and more specifically for the preventive or curative treatment of gastric and duodenal ulcers.

Diverted from its first indication, it would present dangers for patients and will be withdrawn from the market from March 2018 announced the National Agency of Health Products and Medicines (ANSM) during the 6th general meeting of nosocomial infections and the patient safety on October 19th.

What is the problem with Cytotec?

If it does not pose a real problem and is even very effective when taken orally for a drug induced abortion, it can however cause serious consequences on the mother and the child, or even lead to their death in case tearing of the uterus, when administered vaginally to trigger a term birth of a viable child.

Indeed, the dosage and conditioning of Cytotec do not guarantee the administration of a reliable dose to patients for gynecological obstetric indications.

This misuse is not forbidden yet. The doctor can make the decision to use it or not after evaluating the scientific data collected on the latter and the risks to which the patient and her child may be exposed.

A practice denounced by associations of patients like "Timéo and the others" * or "The Link" **, victims of the deleterious effects of the drug.

A warning from the health authorities since 2013

In February 2013, the National Agency of Health Products and Medicines already alerted health professionals about the risks associated with such diversion ***:

"In the onset of delivery from 37 weeks of amenorrhea, the use of unauthorized specialties, regardless of the route of administration, poses serious risks to the mother and the child. Serious adverse events have been reported with use of Cytotec in the initiation of labor such as uterine rupture, bleeding, or abnormal fetal heart rate. "

In a recent information point ****, the health authority recalls that other medicines with marketing authorization are available on the French market: Propess (Dinoprostone) for deliveries; Gymiso and MisoOne (misoprostol) for voluntary inturbations of pregnancies.

* https://timeo-asso.fr/index.php?page=sa-birth
** https://lelien-association.fr/asso/index.php
*** https://ansm.sante.fr/S-informer/Points-of-information-Points-of-information/Missing-guard-on-the-risks-potential-lies-for-use-off -AMM du Cytotec, misoprostol-in-the-triggering-from-birth-and-all-else-use-gynecological-Point-of-information
**** https://ansm.sante.fr/S-informer/Communiques-Communiques-Points-presse/Cytotec-misoprostol-arret-de-commercialisation-a-compter-du-1mar-Mars-2018-Communique