Evidence map›Paper›PMID 40824302›Full record

ArticleEuropean journal of clinical pharmacology2025

Meningioma in users of progestogen contraceptives: a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS).

Richard H Woods

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Article in European journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

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2citing papers in PubMed
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3 · Its place in the literature

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2 citing papers in PubMed.

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5 · Who and what money

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1 author.

Richard H WoodsRollins School of Public Health, Emory University, Atlanta, GA, USA. rwoods@levinlaw.com.ORCID http://orcid.org/0000-0001-9583-9105

Funding

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6 · The paper itself

Abstract

purposeRecent observational studies have suggested certain progestogens used for contraception may increase the risk of intracranial meningioma. This study analyzed meningioma reporting among females to the US Food and Drug Administration Adverse Event Reporting System (FAERS) across all progestogen-based contraceptives currently approved in the USA.

methodsDisproportionality analysis was performed using individual case safety reports (ICSRs) submitted to FAERS (second quarter of 2016-first quarter of 2024) involving nine progestogens approved for contraception in the US. Eleven Medical Dictionary for Regulatory Activities (MedDRA) preferred terms classified meningioma cases. Crude and adjusted reporting odds ratios (RORs) and 95% confidence intervals (CIs) were estimated using logistic regression. A lower 95% CI > 1.0 and ≥ 3 meningioma cases constituted a disproportionality signal.

resultsDuring the study period, progestogen contraceptives were reported in 136,654 ICSRs and 283 meningioma cases involving females. Seven progestogens exhibited positive meningioma disproportionality signals in univariable analyses. In multivariable models adjusting for age, weight, use of any medication for contraception, number of associated drug-event pairs, reporter country, and reporter occupation, potential meningioma signals were detected for desogestrel (ROR 2.22; 95% CI 1.29-3.83), levonorgestrel (ROR 3.21; 95% CI 2.11-4.86), and medroxyprogesterone acetate (ROR 4.01; 95% CI 2.10-7.66). Meningioma disproportionality signals for levonorgestrel and medroxyprogesterone acetate persisted through several sensitivity analyses.

conclusionNotwithstanding the important limitations of disproportionality analyses, these findings add to a growing body of literature describing a potential association between progestogen-based contraceptives and meningioma. Screening should be recommended for progestogen-treated females experiencing symptoms consistent with meningioma.

Indexed as

Adverse Drug Reaction Reporting SystemsMeningeal NeoplasmsMeningiomaProgestinsAdolescentAdultFemaleHumansMiddle AgedUnited StatesUnited States Food and Drug AdministrationYoung AdultProgestinsContraceptionLevonorgestrelMedroxyprogesteroneMeningiomaProgestogens

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.