The South African Health Products Regulatory Authority (SAHPRA) has advised that the product information for medroxyprogesterone acetate (MPA) be updated to include revised safety warnings, including the risk of meningioma.
MPA is a synthetic oral and injectable form of the hormone progesterone and is used for birth control 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,” the local watchdog explained.
MPA-containing products registered in South Africa are Depo-Provera, Provera, Petogen, Medroxyprogesterone Mylan, Sayana, Omrastoz, Trivina, and Triclogyn.
SAHPRA said it was informed by a holder of a Certificate of Registration (HCR) of regulatory action taken in Europe concerning 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.”
Meningiomas
Meningioma is a slow-growing tumour that develops in the meninges, the membranes that cover the brain and spinal cord.
The signs and symptoms of meningiomas vary depending on the tumour’s location.
“Meningiomas are the only brain tumour more common among women than men. Meningiomas tend to occur in middle-aged and older adults.”
The available evidence indicates that there may be an increased risk of developing meningioma in individuals taking MPA.
However, the occurrence of meningioma is expected to be very rare.
According to global reports, there have been 32 cases identified over a 20-year period from 2004 to 2024.
SAHPRA believes that the absolute risk of developing meningioma is low, especially considering the widespread use of MPA-containing products.
“Currently, no cases have been reported in South Africa. 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.”
Meanwhile, the increased risk of meningioma was also detected with prolonged use of medrogestone and promegestone, which are progestogens that can be used to treat menstrual irregularities and breast cancer.
However, SAPHRA said no medicines containing progestogens are marketed in South Africa at present.
Advice for healthcare professionals
Healthcare professionals have been encouraged to provide counselling to patients about the side effects of MPA detailed in the product information https://pi-pil-repository.sahpra.org.za/.
It is also recommended that patients treated with MPA be monitored for signs and symptoms of meningioma under clinical practice.
“If a meningioma is diagnosed in any patient treated with MPA for a non-oncological indication, the use of MPA must be stopped, as a precautionary measure.”
Meanwhile, if a meningioma is diagnosed in any patient treated with MPA for an oncological indication, the need for further use of MPA should be carefully considered on a case-by-case basis, considering individual benefits and risks.
Advice for patients
Patients should talk to a healthcare professional before taking or continuing MPA.
“It is important to use MPA for its approved indications and to follow the directions for use provided by healthcare professionals.”
Healthcare professionals and members of the public are urged to report any suspected adverse drug reactions (ADRs) related to the use of MPA and other health products to SAHPRA.
This can be completed through the eReporting link on the SAHPRA website https://www.sahpra.org.za/e-services/ or by filling out an ADR reporting form available on the SAHPRA website and emailing it to adr@sahpa.org.za.
Alternatively, reporting can be done via the Med Safety App, downloadable through Google Play or the Apple App Store. – SAnews.gov.za
