Cytotec (misoprostol) obtained a Marketing Authorization (AMM) in France in 1986 for the treatment of ulcer gastric or duodenal and peptic lesions induced by nonsteroidal anti-inflammatory drugs (NSAIDs). But as this drug also has the property of causing contractions, it is also used (except Marketing Authorization) in gynecology for medicated abortions and in obstetrics for the onset of childbirth.
But this misuse involves risks for the mother and for the child. This is why, following numerous health alerts, the Pfizer laboratory has announced that it is withdrawing Cytotec from the market. A decision that will be effective in March 2018.
Risk of uterine rupture and bleeding
Three years ago, the National Medicines Safety Agency (ANSM) published a warning against the potential risks of the off-label use of Cytotec: “In the induction of childbirth from 37 weeks of amenorrhea, the use of unauthorized specialties, whatever the route of administration, poses serious risks to mother and child. , serious side effects have been reported with the use of Cytotec in induction of labor such as uterine rupture, bleeding or abnormal fetal heart rate “.
The ANSM then recalled that the High Authority for Health (HAS) had published professional recommendations on the conditions that allow artificial induction of labor, whether for a medical or non-medical indication, and the methods used for this induction. These methods include detachment of membranes and the use of specialties containing dinoprostone approved for this indication. “To date, misoprostol has no marketing authorization for the induction of labor” underlined the ANSM.
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