Article here: https://www.lequotidiendecin.fr/actus-medicales/medica/progestififies-et-surrisque-de-meningiome-les-gynecologists-salarment-du-recours-excessive-au-principe?

"A great first for a health agency: will the precautionary principle replace the demonstration of evidence? » . It is in these terms that nearly a dozen learned gynecology companies* describe in a joint press release the attitude of the Medicines Agency (ANSM) in its preliminary recommendations on the risk of meningioma and progestins.

Following the highlighting in 2019 of a Méningioma Ombrance associated with three progestins (Androcur, Lotényl, Lutéran and their generics), the health agency issued preliminary recommendations for other progestins on March 3, fearing "a class effect" .

Pending the results of Epi-Phare Studies (ANSM, CNAM), the agency's temporary scientific committee (CST) called for the prescription of the Medrogestone (Colprone 5 mg), progesterone 100 or 200 mg (utrogestan and generics), Dydrogesterone (DuPhaston 10 mg) and Diénogest (Generic Visanne 2 mg). Data on cases of meningioma under progestins are "particularly" suggestive of a role of medrogestone and progesterone at 100 mg and 200 mg, "given stabilization or tumor regression when stopping treatment" , had underlined the CST.

Awareness of the duration of treatment

In addition to the contraindication in the event of a history of meningioma, the agency thus recommends, before any new prescription or change of progestin, " to check all the progestins already used and their duration of use" . The treatment must be prescribed at the minimum effective dose with the shortest possible duration of use. The continuation of treatment must be reassessed every year, " especially around menopause, the risk of meningioma increasingly increasing with age " continues the ANSM.

An appeal to prudence that the signatories of the press release do not share, including the National College of French Obstetricians (CNGOF) and the Menopause Study Group and Hormonal Aging (GEMVI). "These recommendations which concern all the progestins currently reimbursed as well as natural progesterone are indeed based to date only on some reported cases of meningioma in the absence of any scientific study ," they underline.

Professionals are concerned with "the consequences of this media coverage" of preliminary recommendations, "without any assessment of a level of risk for designated progestins (Diénogest, Dydrogesterone, Médrogestone) and on natural progesterone" .

Endometrium cancer prevention

If gynecologists agree on raising awareness among health professionals about the duration of use of progestins, they call to cease "to worry women on" suggestions "of not evaluated risk" .

The signatories thus recall "the major role of progestins in the prevention of endometrial cancer and in the treatment of benign gynecological diseases" , which has made it possible to significantly reduce the use of hysterectomy. And to quote some "essential" of prescription: medical aid for procreation; Hormonal treatment of menopause associating 17 beta-estradiol and natural progesterone; Hypogonadotropic hypogonadism or premature ovarian insufficiency; Polycystic ovary syndrome (SOPK) in order to limit the hyperplasia of the endometrium; Support for endometriosis.

"So many clinical situations would leave patients without any therapeutic resources if it is not to increase the prevalence of hysterectomies ," they argue. Gynecologists, not without a touch of annoyance, also report that women who have had children ( "whose progesterone rate is multiplied by a factor 6 to 8 during their pregnancy" , reads) have no more meningiomas compared to nulliparous women, according to a study published in April 2021 in "Scientific Reports", a review of the "Nature" group.

*GEMVI (Menopause Study Group and Hormonal Aging - French Society of Menopause), the CNEGM (National College of Medical Gynecology Teachers), the CNGOF (National College of French Gynecologists and Obstetricians), the FNCGM (National Federation of Medical Gynecology Colleges), the SFG (French Gynecology Society) CNPGO-GM (Obstetrics National Professional Gynecology Council and Medical Gynecology), SEUD (SOCIETY OF ENDOMETRIOSIS AND UTERINE DISORDERS), FFER (French Federation of Reproduction Study) and SMR (Society of Reproductive Medicine)