FOI release

Request for Yellow Card data relating to medroxyprogesterone acetate

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2026/01040

Received 11 September 2026

Published 6 November 2026

Request

I am writing to request information held by the Medicines and Healthcare products Regulatory Agency (MHRA) concerning suspected adverse drug reactions (ADRs) reported through the Yellow Card Scheme in relation to medroxyprogesterone acetate (MPA). I understand that the MHRA has previously confirmed that detailed, appropriately anonymised Yellow Card information can be disclosed under the Freedom of Information Act. I am therefore seeking aggregate statistical information rather than any personally identifiable information. For clarity, I am requesting data relating to the active substance medroxyprogesterone acetate, rather than limiting the search to the individual brand name Depo-Provera. This is important because medroxyprogesterone acetate is used in different products and formulations, including Depo-Provera and Sayana Press, and I wish to understand the full pharmacovigilance reporting history associated with the substance. 1. Total number of Yellow Card reports Please provide the total number of UK Yellow Card reports of suspected adverse reactions associated with medroxyprogesterone acetate, from the earliest date for which records are available up to and including 31 August 2026. Please provide the figures cumulatively as well as, where possible, broken down by calendar year. 2. Annual breakdown Please provide the number of suspected ADR reports involving medroxyprogesterone acetate for each calendar year, from the earliest available year through to 31 August 2026. If the data are available in a different reporting period or format, please provide the closest equivalent and explain the period used. 3. Breakdown by suspected adverse reaction Please provide the number of reports associated with each suspected reaction/reaction term recorded against medroxyprogesterone acetate. In particular, I would like the following categories specifically identified where they are present within the Yellow Card data: - Meningioma - Multiple meningiomas - Intracranial tumour - Brain tumour - Other central nervous system/neoplastic disorders - Neurological disorders - Visual disorders - Headache - Migraine - Seizures/convulsions - Pituitary disorders - Cognitive disorders - Memory disorders - Psychiatric disorders - Mood disorders - Muscle atrophy - Lipodystrophy - Osteoporosis - Other bone disorders - Diabetes/metabolic disorders - Thromboembolic disorders - Cerebrovascular disorders Where the MHRA uses a specific MedDRA Preferred Term (PT), Lowest Level Term (LLT), System Organ Class (SOC), or other coding terminology rather than the wording above, please provide the corresponding coded term and explain the classification used. I am particularly interested in ensuring that reports are not excluded simply because the reporter used wording such as "brain tumour", "intracranial tumour" or "multiple meningiomas" rather than the exact term "meningioma". 4. Product/brand information Where this information is held, please provide a breakdown of reports according to the suspected product/formulation, including: - Depo-Provera - Sayana Press - Other injectable medroxyprogesterone acetate products - Oral medroxyprogesterone acetate products If the MHRA's database does not permit a direct brand-level breakdown, please state this clearly and provide the closest available breakdown. 5. Route of administration Please provide the number of reports according to route of administration, where recorded, including: - Intramuscular - Subcutaneous - Oral - Other/unknown 6. Seriousness of reports Please provide the number of reports classified as serious and non-serious, where this classification is available. If possible, please also provide the number of serious reports associated specifically with meningioma. 7. Reporter type Please provide the number of reports according to reporter type, where recorded, including: - Patient/member of the public - Healthcare professional - Pharmaceutical company/manufacturer - Other reporter type - Unknown/not recorded Again, I would particularly welcome this breakdown for reports involving meningioma. 8. Reported outcomes Where available, please provide aggregate information concerning the reported outcome of the suspected ADR, including: - Hospitalisation - Life-threatening reaction - Disability/incapacity - Congenital abnormality - Fatal outcome - Recovery - Recovering - Not recovered - Recovered with sequelae - Unknown/not recorded I am particularly interested in the outcomes associated with reports of meningioma and multiple meningiomas. 9. Meningioma reports – before and after the October 2024 safety communication Please provide the number of Yellow Card reports concerning meningioma associated with medroxyprogesterone acetate received: a) before the MHRA/Pfizer safety communication issued in October 2024; and b) from the date of that communication through to 31 August 2026. If possible, please provide this as a year-by-year cumulative or annual breakdown so that the reporting pattern before and after the safety communication can be examined. For example: Period| Number of meningioma reports Earliest available year – 2023| 2024, before October communication| October–December 2024| 2025| 1 January–31 August 2026| If the MHRA holds the information in a form that permits a more precise comparison, please provide that instead. 10. Historical cumulative meningioma reports Please provide, if available, the annual cumulative number of meningioma reports associated with medroxyprogesterone acetate, from the earliest recorded report through to 31 August 2026. I am specifically seeking to establish how the number of reported cases has developed over time and whether there was any change in reporting following the recognition and communication of the meningioma risk. 11. Multiple meningiomas Please separately identify, where possible, reports in which multiple meningiomas were reported. If multiple meningiomas are not separately coded from meningioma generally, please confirm this and provide the relevant coding/category used by the MHRA. 12. Historical changes in coding or reporting If there have been changes to the coding, terminology, reporting system, product categorisation or treatment of medroxyprogesterone acetate ADR reports during the period covered by this request that could affect comparison of historical and current figures, please provide details of those changes. 13. Publicly available information I appreciate that some Yellow Card information is available through the MHRA's public reporting tools, including iDAP. However, this request is specifically for aggregate historical information and cross-tabulated data held by the MHRA, including annual figures, reaction-specific figures, meningioma figures, pre- and post-October 2024 comparisons, seriousness, reporter type, route and product/formulation where available. I am therefore not requesting that I simply be directed to the publicly available iDAP search facility. If any part of the information requested above is already publicly available, please identify precisely which information is available and provide the corresponding publication/database reference. I would nevertheless be grateful for the additional aggregate information requested above where it is held by the MHRA. 14. Data limitations If any of the requested breakdowns cannot be provided because the MHRA does not routinely record the information, please specify which elements are unavailable rather than treating the entire request as unavailable. If some of the requested information would exceed the appropriate cost limit, please provide the information that can be supplied within the limit and advise which elements would need to be narrowed or reformulated. I am happy for the information to be supplied electronically, preferably in Excel, CSV or another machine-readable format, where possible. I confirm that I am seeking aggregate, anonymised statistical information only and do not require any patient-identifiable information. This request is being made to assist with research into the long-term pharmacovigilance history of medroxyprogesterone acetate, particularly in relation to meningioma and the development of the recognised safety information surrounding prolonged exposure. Thank you for your assistance. I look forward to your response within the statutory timeframe.

Response

See attached

Documents

• Annex 1 UK Spontaneous suspected ADR reports for Medroxyprogesterone up to and including 14 September 2026 by brand.pdf (31.6 KB)
• Annex 2 UK Spontaneous suspected ADR reports for Medroxyprogesterone up to and including 14 September 2026 reaction outcome.pdf (32.9 KB)
• Annex 3 UK Spontaneous suspected ADR reports for Meningioma and Medroxyprogesterone up to and including 14 September 2026 reaction outcome.pdf (33.7 KB)
• Annex 4 UK Spontaneous suspected ADR reports for Meningioma and Medroxyprogesterone up to and including 14 September 2026 before and after 31 October 2024.pdf (31.6 KB)
• FOI2026 01040 response (redacted).pdf (3.4 MB)

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