- Design
- Pharmacovigilance disproportionality analysis (ROR, IC, EBGM)
- Population
- 21,091 EudraVigilance reports for five hormonal contraceptives, 2016–2025
- 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)
Italian pharmacovigilance researchers searched ten years of EudraVigilance reports (2016–2025) for meningioma among five hormonal contraceptives, using three disproportionality methods. They found 21,091 reports in total.
Desogestrel-only pills carried a clear reporting signal: 110 meningioma reports, reporting odds ratio 11.11 (95% CI 8.79 to 14.06). Drospirenone-only pills showed a weaker exploratory signal from 8 reports (ROR 2.41, 1.19 to 4.89). No signal appeared for the two combined pills studied or for levonorgestrel.
This matters because the association between some progestins and meningioma is already established for high-dose agents such as cyproterone and nomegestrol, and progestin-only pills are often the default for women who cannot take oestrogen. A reporting signal, though, is not a risk estimate: there is no denominator of users, and publicity or prior warnings can drive reporting.
In practice, this does not justify switching women off a method that suits them. It is reason to ask about new persistent headache, visual change or focal symptoms in long-term users, and to review the progestin if a meningioma is found.
- Ask long-term progestin-only pill users about new persistent headache, visual disturbance or seizures.
- If a meningioma is diagnosed, record the hormonal method and duration and discuss review with neurosurgery.
- Do not switch a well-suited method on the basis of this signal alone.
- Combined pills and levonorgestrel showed no signal, but the authors stress this is not proof of safety.
Why it matters
The progestin-meningioma link may extend beyond high-dose agents to the low-dose pills offered when oestrogen is unsuitable.
Don't overread it
Disproportionality in spontaneous reports cannot measure how often meningioma occurs or show that the pill caused it.
The statistics, in plain English
A reporting odds ratio of 11 means meningioma was named about eleven times more often among reports for desogestrel-only pills than among reports for other drugs in the database. It says nothing about how many users develop meningioma, because the number of women taking the pill is unknown. The drospirenone signal rests on eight reports, so its interval is wide and its lower bound barely above 1.
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