The ANSM warns gynecologists against the misuse of an anti-ulcer drug, Cytotec. Used to induce childbirth, it can sometimes prove to be dangerous for the woman and her baby.
“We narrowly escaped.” These are the words of Aurélie, 31, in the daily 20 minutes, an angry woman who now wishes to alert future mothers against the dangers of Cytotec. In November 2010, during her delivery, she was given Cytotec to speed up delivery. The result is stronger contractions, the baby’s heart slows down, and the mom’s uterus tears. Today, little Timéo suffers from a motor handicap. This drug, questioned by many mothers who gave birth in the same circumstances as this young woman, however, has been granted marketing authorization. But, for a whole other use.
Cytotec obtained Marketing Authorization in France in 1986. It is currently indicated in particular in the treatment of gastric ulcer or as a preventive measure against gastric lesions and serious complications induced by non-steroidal anti-inflammatory drugs (such as ibuprofen, for example). ). However, the ANSM has become aware of an off-label use of Cytotec in obstetrics to induce childbirth from 37 weeks of amenorrhea. But also to promote the expulsion of the fetus in the case of abortion or miscarriage. However, to date there are no data on the safety of use which suggests a favorable benefit / risk ratio for Cytotec in this indication, regardless of the route of administration. In addition, according to the accounts of many mothers, this off-label use could even lead to serious adverse effects for the mother and the child such as ruptures of the uterus, hemorrhages or abnormalities in the heart rate of the fetus.
In order to avoid a new health scandal, the ANSM warned on Monday February 25, via a press release, the gynecologists against this dangerous off-label use. For Prof. Joseph Emmerich, director of the ANSM cardiology, endocrinology, gynecology and urology drugs department, the message to gynecologists is clear, no more use of Cytotec outside of Marketing Authorization.
Listen to Pr Jospeh Emmerich, director at ANSM: “CThe drug has no Marketing Authorization for any gynecological indication. Given the risk of serious adverse events, we have warned gynecologists … “
In addition, Professor Joseph Emmerich recalls, other drugs exist to facilitate childbirth. Commonly used, unlike Cytotec, they present no danger to mother and child.
Listen to Prof. Joseph Emmerich, director at ANSM: “For the initiation of childbirth, there are other possibilities and other molecules commonly used with an MA and these are the ones that should be favored.“
After Diane 35, Cytotec is therefore part of a long list of drugs diverted from their main indication. As proof, the ANSM warning of Monday February 25 also concerns Gymiso, a drug which contains the same molecule as Cytotec and “which must not be used in the artificial induction of labor. ” concludes the Agency.
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