DailySun
Pretoria – The South African Health Products Regulatory Authority (SAHPRA) has announced an update to the product information for medroxyprogesterone acetate (MPA) products, placing emphasis on newly updated 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, and is used for contraception as well as for easing pain linked to endometriosis.
“Moreover, it is approved for the palliative care of recurrent and/or metastatic endometrial cancer, renal cancer, and breast cancer in women who are postmenopausal,” SAHPRA noted in a brief statement on Friday, January 17, 2025.
The MPA products registered in South Africa consist of Depo-Provera®, Provera®, Petogen®, Medroxyprogesterone Mylan®, Sayana®, Omrastoz®, Trivina®, and Triclogyn®.
SAHPRA has been informed by a Holder of a Certificate of Registration (HCR) about regulatory actions taken in Europe related to MPA-containing products, which underscore the possible risk of meningioma.
This regulatory move, which included updates to product labeling, was prompted by the results of two epidemiological studies conducted in France and the United States, which found an elevated risk of cerebral meningioma associated with long-term use of MPA.
