Pretoria – The South African Health Products Regulatory Authority (SAHPRA) has recommended that the product information of medroxyprogesterone acetate (MPA) – containing products be amended by updating the safety warnings to include the potential risk of meningioma.
MPA is a synthetic oral and injectable form of the hormone progesterone and is used for contraception and the management of endometriosis-associated pain.
“It is also indicated in the palliative treatment of recurrent and/or metastatic endometrial cancer, renal cancer, and breast cancer in postmenopausal women,” SAHPRA said in a terse statement Friday, (17 January 2025).
The MPA-containing products registered in South Africa are Depo-Provera®, Provera®, Petogen®, Medroxyprogesterone Mylan®, Sayana®, Omrastoz®, Trivina® and Triclogyn®
SAHPRA said it has been informed by a Holder of a Certificate of Registration (HCR) of regulatory action taken in Europe in respect of products containing MPA, noting the potential risk of meningioma.
The regulatory action, which entailed updating product labelling, was based on the results of two epidemiological studies conducted in France and the United States, which observed an increased risk of cerebral meningioma with prolonged use of MPA.
