FSRH CEU Statement : New advice from the MHRA regarding cyproterone acetate

Posted 13 July 2020

Date: 13 Jul 2020

Type: FSRH Clinical Guidance and Clinical Statements

How does this affect prescribing of Co-cyprindiol/Dianette® for acne/hirsutism?

MHRA advises that individuals who have had a meningioma should not use any product containing cyproterone acetate. Women without a history of meningioma may use Co-cyprindiol/Dianette for management of acne/hirsutism; clinicians should be vigilant for symptoms and signs of meningioma.

FSRH CEU recommends that cyproterone acetate should not be used by individuals with a history of meningioma. Individuals that have not had meningioma may consider use  of cyproterone acetate 2mg with ethinylestradiol for acne/hirsutism. They should be made aware that increased risk of meningioma associated with cumulative exposure to low dose cyproterone acetate cannot be excluded, but risk is likely to remain very low.

New data from a French cohort study indicate that use of high dose cyproterone acetate (high dose products contain 50-100mg per tablet) is associated with significantly increased risk of meningioma. In the study, meningioma risk increased with increasing cumulative cyproterone acetate exposure over time; a cumulative dose of 12-36g was associated with an estimated 6-fold greater risk (annual incidence 26 per 100,000 users) than a cumulative dose of less than 3g (annual incidence 4.5 per 100,000). For reference, the MHRA estimates annual incidence of meningioma in the general population to be about 6 per 100,000.

Preparations containing low dose cyproterone acetate with ethinylestradiol
Co-cyprindiol/Dianette® tablets containing cyproterone acetate with ethinylestradiol are used for treatment of acne and hirsutism in women of reproductive age. In contrast to the high dose products described above, they contain only 2mg of cyproterone acetate; annual cumulative exposure to cyproterone acetate is only about 0.8g. The Yellow Card scheme has received no reports of meningioma associated with use of these low-dose products. The MHRA advises that although exposure to this low dose of cyproterone acetate has not been shown to increase risk of meningioma, an association is plausible and cannot be excluded.

Download the statement below.