Pretoria – The South African Health Products Regulatory Authority (SAHPRA) has announced an update to the product information for medroxyprogesterone acetate (MPA) products, highlighting new safety warnings related to the potential risk of meningioma.

MPA is a synthetic version of the hormone progesterone, available in both oral and injectable forms, used for birth control and to ease pain from endometriosis.

“Furthermore, it is indicated for the palliative care of recurrent and/or metastatic endometrial cancer, renal cancer, and breast cancer in postmenopausal women,” SAHPRA stated succinctly on Friday, January 17, 2025.

The MPA products approved in South Africa encompass Depo-Provera®, Provera®, Petogen®, Medroxyprogesterone Mylan®, Sayana®, Omrastoz®, Trivina®, and Triclogyn®.

SAHPRA has been informed by a Holder of a Certificate of Registration (HCR) regarding regulatory actions taken in Europe concerning MPA-containing products, emphasizing the possible risk of meningioma.

This regulatory event, which included updates to product labeling, was based on the results of two epidemiological studies conducted in France and the United States, which found an increased risk of cerebral meningioma associated with long-term MPA use.