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Induced childbirth: the case of Cytotec
Marketed by the Pfizer laboratory, Cytotec has long been used during childbirth to induce labor. Following several reports and due to the risk of overdose, it was finally on the French market from March 1, 2018.
As early as 2013, the National Medicines Safety Agency warned of very serious adverse effects for mother and baby, due to excessively violent uterine contractions: bleeding during delivery and poor oxygenation of the fetus that could lead to severe disabilities.
Induction of childbirth: why was Cytotec used?
In some maternity hospitals, Cytotec was used outside of its Marketing Authorization (Marketing Authorization; here given for the treatment of stomach ulcers) for the induction of labor after term, vaginally, or for drug-induced termination of pregnancy (abortion). Indeed, misoprostol is a molecule of the prostaglandin family, effective in triggering contractions. In addition, Cytotec was cheap (30 cents per tablet), unlike other trigger products, such as prostaglandin gels and other tampons to dilate the cervix (especially Propess) which are close to 90 euros.
Cytotec, a tablet considered useful and practical by some gynecologists
In 2017, a standoff began between the French Medicines and Health Products Safety Agency (Ansm) and obstetrician gynecologists around Cytotec, a molecule which was then used and diverted from its usual use for years. to induce childbirth, and which was the subject of a warning from the Ansm, before being finally withdrawn from the market.
Following the warning, the French gynecologists were quick to react. In a punchy statement, the College of Obstetrician Gynecologists protested against the recent warning from the French Medicines Agency on the risk associated with the use outside the Marketing Authorization (AMM) of Cytotec (misoprostol) in the induction of childbirth. ” We’re going too far, indignantly Professor Hédon. This “caveat” ignores obstetrics practice. Many products are used today without having obtained marketing authorization. Which does not mean that they are not valid. » According to the College, there would be “ academic studies, French and foreign, which validate the use of this drug to induce childbirth. Quite simply, the laboratories would not be ready to finance work which could make it possible to obtain the MA. “ By dint of the precautionary principle, we fall into a form of regression in the quality of medicine », Regretted Professor Hédon. Remember that in 2017, Cytotec did have Marketing Authorization, but for a completely different purpose: the treatment of gastric ulcer.
Cytotec and induction of labor: risks of overdose and numerous testimonials
Following the warning from the Medicines Agency, the Interassociative Collective around Birth (CIANE) was inundated with calls. ” It was believed that the use of this product was marginal. We realize that not at all, then observed its President, Chantal Ducroux-Schouwey.Many women triggered with Cytotec have had complications during childbirth. “In France, five serious incidents potentially linked to this product were noted between 1985 and 2017, according to the ANSM. The association “Timéo et les autres”, for its part, brings together victims of Cytotec, that is to say women who have experienced childbirth ” in catastrophic conditions ‘. ” But what is the drug that, causing uterine contractions to induce labor, does not increase the risk of uterine rupture, bleeding or abnormal fetal heartbeat? “Asked the College of Gynecologists during the warning.
It all depends on the circumstances in which it is administered. For example, this product should not have been used in women who have already given birth by cesarean section because the risk of uterine rupture is increased. The problem would also lie in the dosage, because difficult to cut the tablet well to administer the right dose!
«1/8 of this drug has been shown to give the same effects as other products (oxytocin, prostaglandins). But in general 1/4 of the tablet is given. It’s far too violent.The other question that arises: if there are alternatives that have received Marketing Authorization, why has this drug been used so much? Le Ciane requested that the practice of triggering by Cytotec be abandoned without a Marketing Authorization. The group also insisted on the duty to inform patients. As Chantal Ducroux-Schouwey said: “ the testimonies we receive show that the information provided by doctors is far from complete on the issue of risks. »
Fortunately, Cytotec has been withdrawn from the market, effectively eliminating this overdose problem, since the drugs used in place of Cytotec are much easier to dose accurately.
In addition, social networks and hashtags relating to childbirth or even gynecological and obstetric violence have forced gynecologists and obstetricians to question themselves and include their patients in their care, by explaining more about drugs and maneuvers that they might need to use during childbirth.