Diane 35 and risk of meningiomas
Presentation :
According to the instructions, Diane 35 micrograms, coated tablet should be used only after failure of topical treatment or systemic antibiotic treatments. Since Diane 35 micrograms, coated tablet is also a hormonal contraceptive, it should not be used in combination with other hormonal contraceptives.
The active ingredients are: cyproterone acetate , ethinylestradiol
Cyproterone acetate is dosed at 2 mg per tablet
Action mechanism: how does it work?
Diane 35 is an east-antiandrogenic association, weakly dosed in estrogen, has the properties of the two substances:
-The specific antiandrogenic effect of cyproterone acetate , by competitive inhibition of the binding of 5-α dihydrotestosterone to the cytosolic receptor of target cells, which slows down the production and excretion of sebum, growth and hair development.
-Derived from 17-α-hydroxyprogesterone, it has a progestin action. Its antigonadotropic action is amplified by that of ethinylestradiol. Cyproterone acetate does not have an estrogenic action but an anti -estrogenic effect, nor harmful action on the function of the adrenal cortex.
- The trophic effect on the endometrium and the antigonadotropic action of the 35 µg of ethinylestradiol.
The ANSM (drug safety agency) has for years made alerts to this treatment, alerts relayed in the press, on deaths for multiple serious pathologies other than meningiomas, for example here
In the drug database of the drug, there is no mention to date of meningiomas. See here: http://base-donnees-publique.Medicments.gouv.fr/Afficuigedoc.php?specid=64066269&typedoc=n
Diane 35 was suspended in 2013 (see here ) to be returned to the market in 2014 (see here )
many gynecologists refused to prescribe it: example here
and here, in 2013, where the journalist of the Cheek Magazine site, understood that Andocur and Diane 35 are very close: http://cheekmagazine.fr/societe/androcur-apres-diane-35-lautre-pilule-qui-fa
What about meningiomas with Diane 35?
The study which took place from 2014 to 2018 was afraid of quantifying the risk of meningiomas with cyproterone acetate.
It is written in this study:
case under Diane 35 (AC 2 mg, Ethinylestradiol 0.035mg) 30 patients were exposed to Diane35 in their journey preceding the diagnosis of meningioma. Among them, 25 took Diane35 and Androcur or its generics, 5 took Diane35 without Androcur or its generics. The cases where Diane 35 was taken alone, without AC≥25mg/J found in the drug history, are ultimately rare despite a much larger exposure to Diane 35 than and generic. The cases are not always well documented to be able to conclude that a possible causal link between the taking of low -dose AC (2 mg) over several years and the diagnosis of meningioma .
This study has made it possible to update the link between cyproterone acetate and mingiomas. It has updated that the appearance of meningioma is dose -dependent and duration -dependent. The longer we take this molecule, the higher the dose, the more the risk of meningiomas believes.
In this document dated 11/03/2020, the ANSM mentions the drug Diane 35, to read here .
On 04/27/2020 , in the letter to professionals, the drug Diane 35 (with the Androcur of course), is well mentioned as being at risk of meningiomas:
https://ansm.sante.fr/s-informer/informations-decurite-lettres-aux-professionnels-de-sante/restrictions-de-l-stelization-de-l-acetate-de-cyproterone-aues-au-risque-de-meningiome-lettre-aux-professionnels-de-sante
It is written:
Méningiomes (simple and multiple) cases were reported when using cyproterone acetate, mainly in doses of 25 mg/day and more. The risk of meningioma increases with the increase in cumulative doses.
- The use of cyproterone acetate is contraindicated in patients with meningioma or a history of meningioma.
- Patients treated with cyproterone acetate must be monitored for monitoring and detection of meningiomas in accordance with clinical practice.
- If meningioma is diagnosed in a patient treated with cyproterone acetate, the treatment must be stopped definitively.
- For major female female hirsutisms of non-tumor origin (idiopathic, polycystic ovary syndrome), when they seriously sound about psycho-affective and social life, cyproterone acetate at 50 mg is indicated when the use of drugs based on lower dose cyproterone or other treatment optons has not obtained satisfactory results.
- For the reduction of sexual impulses in paraphilies in combination with psychotherapeutic management, cyproterone acetate at 100 mg can be used when other treatments are deemed inappropriate.
- The use of cyproterone acetate for the following indication remains unchanged: anti-Androgen palliative treatment of prostate cancer.
As a reminder, an information certificate must be signed each year by the patient and his prescribing doctor and given to the pharmacist for any issuance of these drugs.
We can deduce that the risk of meningioma is less with Diane 35 than with Androcur, but that exists.
Regarding studies, you can find them in this part of the site: https://amavea.org/meningiome-etudes/
Diane 35 and risk of meningiomas
