SAHPRA Issues Warning on Meningioma Risk with Medroxyprogesterone Acetate Use, Updates Product Information

Revised Safety Warnings Issued for MPA Following New Studies Linking Prolonged Use to Increased Risk of Meningioma.

The South African Health Products Regulatory Authority (SAHPRA) has announced an update to the product information for medroxyprogesterone acetate (MPA), following new findings linking prolonged use of the drug to an increased risk of meningioma, a type of brain tumor.

MPA, a synthetic form of the hormone progesterone, is widely used for birth control and the management of endometriosis-related pain. It is also indicated for the palliative treatment of certain cancers, including endometrial cancer, renal cancer, and breast cancer in postmenopausal women.

MPA-containing products available in South Africa include Depo-Provera, Provera, Petogen, Medroxyprogesterone Mylan, Sayana, Omrastoz, Trivina, and Triclogyn.

SAHPRA’s decision comes after the European regulatory authorities informed the agency of a regulatory action involving products containing MPA, based on findings from two large epidemiological studies in France and the United States. These studies observed a potential increased risk of cerebral meningioma with prolonged use of MPA, which led to updated product labeling in those regions.

What is Meningioma?

Meningioma is a typically slow-growing tumor that arises from the meninges, the membranes surrounding the brain and spinal cord. It is more common among women, particularly those who are middle-aged or older. While it is often benign, meningiomas can cause a range of symptoms depending on their location, including headaches, seizures, and visual disturbances.

Despite the findings, SAHPRA has assured the public that the absolute risk of developing meningioma remains low, particularly given the widespread use of MPA-containing medications. According to global data, there have been 32 reported cases of meningioma over a 20-year period (2004-2024). No cases have been reported in South Africa thus far.

SAHPRA emphasized that the benefit-risk profile of MPA-containing medicines remains favorable for their approved indications, and that MPA continues to be safe for use in treating its indicated conditions.

Recommendations for Healthcare Professionals and Patients

SAHPRA has encouraged healthcare professionals to counsel patients about the potential side effects of MPA, including the new risk of meningioma. Monitoring for signs and symptoms of meningioma is advised, especially in patients on prolonged MPA therapy.

If meningioma is diagnosed in patients treated with MPA for non-oncological purposes, the use of MPA should be stopped as a precautionary measure. However, if diagnosed in patients using MPA for cancer treatment, healthcare providers are urged to assess the risks and benefits on a case-by-case basis.

Patients are also advised to consult healthcare professionals before starting or continuing MPA therapy, and to use the drug strictly for its approved indications.

Reporting Adverse Reactions

Both healthcare professionals and the public are urged to report any adverse drug reactions (ADRs) related to MPA or other health products to SAHPRA. This can be done through the eReporting link on the SAHPRA website or via the Med Safety App available on Google Play and the Apple App Store.

SAHPRA continues to monitor the safety of health products and remains committed to ensuring public safety in the use of medicines in South Africa.