Published: 3 September 2020

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Cyproterone acetate and the risk of meningioma

Published: 3 September 2020
Prescriber Update 41(3): 51
September 2020

What is a meningioma?

Meningiomas are the most common primary intracranial tumours.¹ Although the majority of meningiomas are benign, they are associated with morbidity and decreased quality of life.¹

Meningiomas can be slow growing and are often asymptomatic.² However, typical symptoms of meningioma include:¹

• headache due to increased intracranial pressure
• focal neurological (including cranial nerve) deficits (eg, visual changes, loss of hearing or smell)
• generalised and/or partial seizures
• personality changes
• confusion
• altered level of consciousness.

The incidence of meningioma increases with age, with a median age at diagnosis of 65 years.² Meningiomas are more common in women.¹ Hormonal factors may have a role in the development of meningioma.²

Cyproterone acetate and reminders for health care professionals

Exposure to cyproterone acetate may increase the risk of meningioma.^3,4 Cyproterone acetate is a synthetic progestogen with anti-androgenic activity.⁴

Cyproterone acetate (as 50 or 100 mg tablets) is indicated:⁵

• in men as an antiandrogen treatment in inoperable carcinoma of the prostate and for the reduction of drive in sexual deviations (pathologically altered or increased sexuality)
• in women for severe signs of androgenisation (eg, very severe hirsutism, severe androgenetic alopecia, often attended by severe forms of acne and/or seborrhoea).

Low-dose cyproterone acetate (2 mg), combined with an ethinylestradiol can also be used in women for the treatment of signs of androgenisation including hirsutism.⁶

A recent cohort study in France has demonstrated a dose-dependent association between cyproterone acetate and the risk of meningioma, and the risk increases as the cumulative dose rises.⁴

Health care professionals are reminded that:⁵

• the occurrence of meningiomas (single and multiple) is associated with the use of cyproterone acetate, primarily at doses of 25 mg/day and above
• use of cyproterone acetate is contraindicated in patients with a meningioma or a history of meningioma
• if a patient treated with cyproterone acetate is diagnosed with meningioma, treatment must be permanently stopped.

New Zealand case reports

Up to 31 March 2020, the Centre for Adverse Reactions Monitoring (CARM) has received two reports of meningioma associated with cyproterone acetate (CARM IDs: 77874 and 100772). Both patients were women who had been treated with cyproterone acetate for more than 10 years. One report stated the dose as 50 mg (CARM ID: 77874). The other report did not include the dose.

References

1. Buerki RA, Horbinski CM, Kruser T, et al. 2018. An overview of meningiomas. Future Oncology 14(21): 2161–77. URL: ncbi.nlm.nih.gov/pmc/articles/PMC6123887/ (accessed 3 July 2020).
2. Park JK. 2020. Epidemiology, pathology, clinical features and diagnosis of meningioma. In: UpToDate 24 June 2020. URL: uptodate.com/contents/epidemiology-pathology-clinical-features-and-diagnosis-of-meningioma (accessed 30 June 2020).
3. Gil M, Oliva B, Timoner J, et al. 2011. Risk of meningioma among users of high doses of cyproterone acetate as compared with the general population: evidence from a population-based cohort study. British Journal of Clinical Pharmacology 72(6): 965–8. URL: ncbi.nlm.nih.gov/pmc/articles/PMC3244644/ (accessed 3 July 2020).
4. MHRA. 2020. Cyproterone acetate: new advice to minimise risk of meningioma. Drug Safety Update 13(11): June 2020: 1. URL: gov.uk/drug-safety-update/cyproterone-acetate-new-advice-to-minimise-risk-of-meningioma (accessed 3 July 2020).
5. Douglas Pharmaceuticals Limited. 2019. Procur New Zealand Data Sheet 22 February 2019. URL: medsafe.govt.nz/profs/Datasheet/p/Procurtab.pdf (accessed 3 July 2020).
6. Bayer New Zealand Limited. 2018. Diane 35 ED New Zealand Data Sheet 13 April 2018. URL: medsafe.govt.nz/profs/Datasheet/d/Diane35EDtab.pdf (accessed 10 July 2020).