Where does this news come from?
The active ingredient of Lutenyl® (brand name) is com.nomegestrol. This is a progestin that is used during perimenopause and after menopause, sometimes in combination with estrogen. Hormone therapy. Nomegestrol Increases the risk of meningioma. Meningiomas are usually benign growths in the membranes surrounding the central nervous system (brain and spinal cord).
The European Medicines Agency sent a warning in September 2022 about reports of medicines based on… com.nomegestrol in Chlormadinone (1). Two recent follow-up studies show this Long term use in Huge doses Of those medications The risk of meningiomas is greater becomes (3,4). Because this is a side effect very rare It is for resources to remain available, but with the message that they are better used As short as possible Used (1).
This applies to medications Brand names Lutenyl® and Nogest®. Nomegestrol is also present in the Zoely® birth control pill, but at a much lower dose (2.5 mg) and in a medicine for treating endometriosis, also at a much lower dose.
Women who use nomegestrol (5 mg: Lutenyl and Nogest) get the message Limit use at the appropriate time One about him Consult a doctor immediately For suspicious symptomslike:
Being meningioma It is not always easy to treat. They are removed surgically, or irradiated if this is not possible.
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How should you interpret this news?
A possible relationship between nomegestrol and meningiomas has been known for a long time and is also mentioned in the Lutenyl® leaflet, among others. But after evaluating new follow-up data, this side effect now appears to be rare It becomes less rare with long-term use and high doses.
- What is meant by “high doses”. 5 to 10 mg nomegestrol Per day. Lutenyl® contains 5 mg of nomegestrol per tablet.
- The researchers calculated this based on recent French studies 2 percent Of women who use nomegetrol, such as Lutenyl®, at a dose of 5 to 10 mg for 10 to 30 years, develop meningioma (4).
Conclusion
Recent follow-up data for nomegestrol, a progestin commonly used in perimenopause and menopause (brand names Lutenyl® and Nogest®), found an increased risk of meningiomas. These are benign tumors in the membranes surrounding the brain and spinal cord. This rare side effect has been known for some time, but it seems to increase the longer you use hormones. For this reason, the European Medicines Agency recommends using nomegestrol-based products for the shortest possible period.
References
- (2) Nguyen B, Huisnard L, Newman A, Zrek M, Weil A. Prolonged use of chlormadinone acetate and risk of intracranial meningioma: a cohort study using SND data. Expanded Program on Immunization – Al-Manara2021.
- (3) Nguyen B, Huisnard L, Newman A, Zrek M, Weil A. Prolonged use of nomegestrol acetate and risk of intracranial meningioma: a cohort study using SNDS data. Expanded Program on Immunization – Al-Manara2021.
- (4) Folia Pharmacotherapeutica November 2022. Meningioma risk and progestins. https://www.bcfi.be/nl/articles/3927.pdf?folia=3919&version=long