Medroxyprogesterone acetate (MPA) - the active ingredient in Depo Provera contraceptive injections, Depo Provera tablets (100mg and 500mg) as well as generic variants Mytricon 150 and Mytricon Medroxyprogesterone Mylan 150 - is a synthetic progestogen widely used for contraception and hormone therapy. Recent studies have raised concerns about a potential link between prolonged MPA use and an increased risk of developing intracranial meningiomas (benign brain tumours).
A comprehensive case-control study published in The British Medical Journal in March 2024 analysed data from over 108 000 women, including 18 000 who underwent meningioma surgery. The findings indicated that women who used injectable MPA for more than a year had a 5.6-fold increased risk of developing intracranial meningiomas compared to non-users. Notably, this elevated risk was associated with prolonged use, as no significant increase was observed for usage less than one year.
Supporting these findings, a 2024 US study published in Cancers examined a large cohort and reported that injection MPA exposure was associated with a 53% increased odds of developing cerebral meningiomas. The risk intensified with longer durations of MPA use. Importantly, this association was specific to cerebral meningiomas, with no significant link observed for spinal meningiomas.
These studies underscore the importance of cautious long-term use of MPA. Healthcare providers and patients should engage in informed discussions about the benefits and potential risks associated with extended MPA use, considering individual health profiles and alternative therapeutic options when appropriate.
In South Africa, the South African Health Products Regulatory Authority (SAHPRA) detailed its efforts to notify healthcare providers and the general public of the suspected link between prolonged MPA use and meningiomas.
How many reported cases of a suspected association between Depo-Provera use and meningiomas are currently with SAHPRA?
As per checks on our database as the time of the interview, there were eight (8) cases.
A Dear Healthcare Professional Letter (DHCPL) on prescribing Depo-Provera was sent out to health professionals. When was this letter distributed and do you have a copy of the letter?
We issued a public statement on the 17 January 2025. However, the DHCPL was issued on 27 February 2025 and published on our website under Vigilance Communication to HCPs.
DHCPL: 27 FEBRUARY 2025
Does the DHCPL go to state and private healthcare professionals?
Yes, the DHCPL goes to both public and private healthcare professionals. Additionally, it is published on SAHPRA’s website and the applicants’ websites.
Does the DHCPL letter go to every healthcare professional individually or is it put on a central website? For example: would a nurse in rural KZN personally receive the letter, or is the Department of Health responsible for sharing the information.
It is issued to all healthcare professionals as per the database of their professional councils.
In terms of the private sector, does the DHCPL go to the Health Professions Council of South Africa (HPCSA) for them to distribute to healthcare providers?
No, the letter is issued to individuals as stated above.
Has the leaflet included with Depo-Provera been updated to reflect the possible risk of meningioma?
All batches produced following the approval of the amended PI (Professional Information) and PIL (Patient Information Leaflets) ought to contain the updated leaflet.
How can members of the public report suspected meningiomas as a result of Depo-Provera to SAHPRA?
All healthcare professionals are aware how to report and information has been placed within PILs on how to report:
- You or your healthcare provider can report using the MedSafety app that can be downloaded via Google Play Store or Apple Store.
- You or your healthcare provider can report using the e-Reporting portal accessible via e-services on SAHPRA’s website.
- Or complete an ADR reporting form found on the SAHPRA website and send it via email to adr@sahpra.org.za
MENINGIOMA SYMPTOMS
Cranial meningiomas are tumours that develop from the meninges, the protective membranes covering the brain and spinal cord. They are typically benign (non-cancerous) and slow-growing, but their presence can lead to various neurological symptoms depending on their size and location.
The manifestations of cranial meningiomas vary based on their position and the structures they affect. Common symptoms include:
- Headaches: Persistent or worsening headaches are often reported.
- Seizures: Unexpected seizures can be an initial indication.
- Neurological Changes: These may encompass muscle weakness, sensory deficits or coordination problems.
- Vision and Hearing Problems: Depending on the tumour's location, individuals might experience visual disturbances or hearing loss.
- Cognitive and Personality Changes: Alterations in memory, concentration, or behaviour can occur.
It's important to note that many meningiomas grow slowly and might not produce noticeable symptoms for years. As they enlarge and exert pressure on adjacent brain tissue, symptoms can progressively emerge.
WHEN TO SEEK MEDICAL ASSISTANCE:
If you or someone you know experiences any of the above symptoms, it's crucial to consult a healthcare provider promptly. Early detection and intervention can significantly influence treatment outcomes.
GENERAL INFORMATION ON OTHER MEDICATIONS AND SIDE EFFECTS
SAHPRA developed educational videos for both healthcare professionals and public creating awareness for reporting and accessing safety information.
- General Public - How to report side effects
- General Public – How to access safety information
- Healthcare Providers – How to report AEFIs/ADRs
- Healthcare Providers – How to access safety information
Sources: The British Medical Journal / SAHPRA / Cancers 2024