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Risks and benefits of progesterone, clarified

There have been 32 cases of meningioma reported in 20 years globally, however none have been reported in South Africa. 

PRODUCTS containing medroxyprogesterone acetate (MPA) may have a potential risk of meningioma, says the South African Health Products Regulatory Authority (SAHPRA). The authority has recommended that this information be included in products which contain MPA.

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“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,” said SAHPRA spokesperson, Madimetja Mashishi.

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

A meningioma is a tumour, usually non-cancerous (benign), that arises from the membranes surrounding the brain and spinal cord.

The information of regulatory action taken in Europe in respect of products containing MPA, noting the potential risk of meningioma, came to the SAHPRA from the Holder of a Certificate of Registration (HCR).

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The regulatory action entailed updating product labelling, based on the results of two epidemiological studies conducted in France and the USA which observed an increased risk of cerebral meningioma with prolonged use of MPA.

SAHPRA wishes to assure the public that the benefit-risk profile of registered MPA-containing medicines remains favourable. MPA is safe to use for its approved indications.

Healthcare professionals are encouraged to provide counselling to patients about the side-effects of MPA detailed in the product information (https://pi-pil-repository.sahpra.org.za/).

 

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