Association between hair-styling pomades and ocular adverse events in Brazilian cosmetovigilance data
Objective: To assess whether notifications involving hair-styling pomades were associated with ocular adverse events versus other cosmetics in Brazilian cosmetovigilance data. Methods: We conducted a retrospective observational study of cosmetic adverse-event notifications from 2007 through 2025 in three Brazilian reporting systems (NOTIVISA, e-Notivisa, and LimeSurvey). Unique notifications with recorded sex, age group, and cosmetic product were included. Ocular adverse events were defined as MedDRA eye-disorder terms in coded or free-text fields. Logistic regression estimated reporting odds ratios adjusted for notification year, region, sex, age group, and self-reported race/skin color. AI-assisted tools were used only for language editing and formatting. Results: Among 3,705 eligible notifications, 686 involved hair-styling pomades and 3,019 other cosmetics. Ocular adverse events were identified in 584 pomade-related notifications and 130 notifications involving other cosmetics (85.1% versus 4.3%). The association persisted after adjustment (adjusted reporting odds ratio: 52.46; 95% confidence interval: 29.18-94.33). Keratitis was the most frequent ocular term among pomade-related notifications. Discussion: Hair-styling pomades were disproportionately associated with ocular adverse events in Brazilian cosmetovigilance data, with most pomade notifications concentrated in 2023. These findings represent a surveillance signal rather than an estimate of incidence or absolute risk and warrant investigation of formulations, stronger postmarketing monitoring, and clinical confirmation.
Authors
- Carolina Müller Ferreira (ORCID: https://orcid.org/0000-0002-7975-5777)
- Marcus Tolentino Silva (ORCID: https://orcid.org/0000-0002-7186-9075)
- Daniel Marques Mota (ORCID: https://orcid.org/0000-0003-4156-0138)
- Nágyla Cristina Sousa Almeida (ORCID: https://orcid.org/0009-0009-6113-548X)
Institutions
- Universidade de Brasília (BR)
- Agência Nacional de Vigilância Sanitária (BR)
Publication Details
- Published
- 2026-10-29
- DOI
- https://doi.org/10.1590/scielopreprints.18604
- Primary Topic
- Pharmacovigilance and Adverse Drug Reactions
- Type
- preprint
Funders
- Agência Nacional de Vigilância Sanitária