Alert: These drugs can cause tumors!
The Ministry of Health issued an alert to the National Council of the Order of Pharmacists. Its object? Risks of development of meningiomas (tumors) because of the prolonged use of certain hormonal treatments.
By Hayat Kamal Idrissi
In a letter dating from December 4, 2020, the Ministry of Health sent an alert missive to the President of the National Council of the Order of Pharmacists. Its object? Warning against the serious side effects of prolonged use of certain hormonal drugs available on the Moroccan market.
Risk of tumors
"Studies have demonstrated the link between the appearance of meningiomas and the use of cyproterone acetate and nomigestrol acetate", describes the mail of the ministry, before specifying that "this risk increases with the dose and the duration of treatment". Following the opinion issued by the National Consultative Commission of Pharmaco-Toxico-Réacto-Materiovigilence and therapeutic trials, the ministry informed pharmacists of its decision to indicate Cyproterone acetate (available on the market under the trade name of Diane 35 2mg /0.035 mg) in people who have had a meningioma.
Recall that cyproterone acetate is a derivative of progesterone with anti-Androgenic properties. The indications depend on the dosage of cyproterone. If tablets at 50 mg are indicated in women, in the treatment of certain hormonal diseases manifesting itself by an increase in the hair system; In humans, this medication is recommended in certain forms of prostate cancer. As for the Androcur 50 mg, also against indicated in the event of meningioma, it is a drug that opposes the effects of male sex hormones (androgens), produced in small quantities by the female body.
In 2019, the Maphar laboratories in accordance with the Directorate of the Medication and the Pharmacy sent a newsletter to health professionals focused on the Latenyl 5 mg compressed medication (Nomestrol acetate); Following the revelation of the proven risk of meningioma in the event of prolonged use. This medication is prescribed in women before menopause in the event of menstrual disorders linked to insufficient or absent progesterone secretion. It is also prescribed in the event of anomalies in the duration of the cycle and functional genital hemorrhages.
Suspicion and surveillance
Suspected of being at the origin of brain tumors at the level of the membranes enveloping the brain and the spinal cord (the meninges), these drugs have been the subject of studies for years. In an information point put online by the French Medicines Safety and Health Products (ANSM) in August 2018, the latter recalls that cyproterone acetate has been monitored since 2009. Supervisory that occurs following the signal issued by France at European level regarding the risks linked to this drug. The assessment of this signal by the European Medicines Agency (EMA) has made it possible to mention this risk in the instructions for drugs based on cyproterone acetate since 2011.
In his new letter to pharmacists and health professionals, the Moroccan ministry calls for the reassessment of the relevance of treatment taking into account the individual benefit-risk of each case, to absolutely make an interrogation to track back history or any meningiomas. The ministry insists mainly on the fact of informing patients of the existence of the risks of developing a brain tumor because of the aforementioned drugs.
Link to the article: https://lobserver.info/alerte-ces-medicaments-peuvent-causer-des-tumeurs/?fbclid=iwar341t80_stup7HWXV4EH2-RDP1_NUDICLVF_BDYX4JZBHDIMRAISU5VTS
