- Design
- Pharmacovigilance disproportionality analysis (ROR, IC, EBGM)
- Population
- 21,091 EudraVigilance reports, 2016–2025, five hormonal products
- Primary outcome
- Disproportionate reporting of meningioma
- Effect
- Desogestrel-only ROR 11.11 (8.79–14.06); drospirenone-only ROR 2.41 (1.19–4.89)
Researchers searched ten years of EudraVigilance reports (2016–2025), covering 21,091 reports, for meningioma among women on five hormonal products, using three disproportionality methods.
Desogestrel-only pills showed a strong reporting signal (110 reports; ROR 11.11, 95% CI 8.79 to 14.06). Drospirenone-only pills showed a weaker, exploratory signal (8 reports; ROR 2.41, 1.19 to 4.89). No signal was seen for the two combined pills studied or for levonorgestrel, which the authors stress is not proof of safety.
This fits earlier concern about meningioma with high-dose progestins such as cyproterone, nomegestrol and medroxyprogesterone, but a disproportionality analysis cannot give a rate. It has no denominator of users, no exposure duration and no control for confounding. It is a reason to take a history, not a reason to switch a stable patient.
- Ask about a history of meningioma before starting any progestin-only method.
- In a woman with a known meningioma, discuss non-hormonal or copper IUD options.
- Investigate new persistent headache, visual change or focal signs on long-term progestin as you would anyone else.
- Do not switch a well-established progestin-only pill on the basis of this signal alone.
- Report suspected adverse reactions through the national pharmacovigilance programme.
Why it matters
Meningioma concern has been attached to high-dose progestins; this raises the question for low-dose daily pills.
Don't overread it
Spontaneous-report signals cannot establish that these pills cause meningioma, or how often.
The statistics, in plain English
A reporting odds ratio compares how often meningioma appears among reports for one drug against all other reports. A high ROR means meningioma is reported disproportionately often — it can be inflated by publicity and prescribing patterns, and it says nothing about how many users actually develop a tumour.
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