Progestins and meningioma: the Medicines Agency establishes new measures | The USA Print

After Androcur, Lutenyl, Lutéran and their generics, the ANSM observed cases of meningioma, an often benign tumor of the envelope of the brain, with other progestins. These hormonal treatments are prescribed as a last resort for women suffering from endometriosis, menstrual cycle disorders or fibroids.

In a press release (source 1), the National Medicines Safety Agency establishes new recommendationswhich relate to progestins medrogestone (Colprone 5mg), progesterone 100 or 200 mg (Utrogestan and generics), dydrogesterone (Duphaston 10mg) and dienogest (generic Visanne 2 mg).

Among the reported cases of meningioma in patients on progestin, the tumor has stabilized or shrunk when treatment is stopped with medrogestone (Colprone) and progesterone 100 mg and 200 mg (Utrogestan and generics). Clearly, this suggests that these drugs would have had a role in the appearance of the meningioma, but also that the possible impact is not irreversible.

A first series of measures to limit the risk of meningioma

  • The prescription “of a progestogen treatment is contraindicated in case of history of meningioma or existing meningioma“, without exception.
  • The progestogen must “be prescribed at the minimum effective dose” and as little time as possible.
  • Before any progestogen prescription, the health professional must check which ones have already been used, and for how long. “The prescription of a new progestogen in relay of a previous treatment with cyproterone acetate, chlormadinone or nomegestrol does not exclude the risk of meningioma, without it being possible for the moment to determine it.”
  • A follow up must be put in place: “the interest in continuing the treatment must be reassessed regularly (every year), in particular around the menopause, the risk of meningioma increases sharply with age“.
  • In the event of neurological symptoms indicative of a meningioma (headache, impaired vision, language, nausea, dizziness, convulsions, etc.), a cerebral MRI should be performed.
  • The summary of product characteristics (SPC) and the Colprone package leaflet have been updated: the risk of meningioma is now indicated.
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Other recommendations could be put in place soon, as epidemiological studies are underway.

Androcur, Lutenyl, Lutéran… what measures already exist for these progestins?

As a reminder, for several years the increased risk of meningioma when taking nomegestrol acetate (Lutenyl and generics) orchlormadinone acetate (Luteran and generics) is known, and patients must be informed of it. In 2021, similar measures were taken by the ANSM: contraindication in the event of meningioma or a history, reassessment of the benefit-risk ratio at least once a year, as well as frequent MRIs.

The risk of meningioma is also higher with Androcur, a progesterone derivative prescribed in the context of certain hormonal diseases in women, prostate cancer in men, or gender transition processes. Measures taken in 2018 “have made it possible to very significantly reduce the risk of meningioma associated with the use of Androcur and its generics” according to the ANSM (source 2).

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