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Pfizer in agreement with the HPRA have released the following update on medroxyprogesterone acetate.
There is an increased risk of developing meningioma with high doses of medroxyprogesterone acetate (all injectable and ≥ 100 mg oral formulations), primarily after prolonged use (several years). This is based on results from a French epidemiological case-control study.
Medroxyprogesterone acetate is available in both injectable and oral formulations for gynaecological (including contraception and endometriosis) and oncological indications.
In Ireland, medroxyprogesterone acetate as Depo-Provera 150 mg/ml Suspension for Injection is indicated for contraception.
Meningioma is a rare, most frequently benign tumour that forms from the meninges. Clinical signs and symptoms of meningioma may be non-specific and include changes in vision, hearing loss or ringing in the ears, loss of smell, headaches that worsen with time, memory loss, seizures or weakness in the extremities. While meningiomas are usually benign, their location may lead to serious consequences and may require surgery.
For contraception or non-oncological indications, medicines containing high doses of medroxyprogesterone acetate are contraindicated in patients with meningioma or a history of meningioma. If meningioma is diagnosed in a patient treated with high doses of medroxyprogesterone acetate, treatment must be stopped. Patients treated with high doses of medroxyprogesterone acetate should be monitored for signs and symptoms of meningioma in accordance with clinical practice.
Healthcare professionals are asked to report any suspected adverse reactions in patients taking medicines containing medroxyprogesterone acetate via HPRA Pharmacovigilance, website: www.hpra.ie
