Understanding the safety profile of topical minoxidil: a retrospective review
摘要
Minoxidil, originally developed as an oral antihypertensive, was later reformulated as a topical treatment for androgenetic alopecia due to its hair growth promoting side effect. While it has proven beneficial, its widespread use facilitated by over-the-counter availability and lack of strict regulation raises safety concerns. Despite being contraindicated in pregnant and breastfeeding women, reports indicate cases of infantile hypertrichosis linked to maternal exposure. Additionally, associations with ocular adverse effects among general population have brought its safety profile into question. This study aims to investigate global reports of infantile hypertrichosis related to maternal Minoxidil exposure and assess serious and non-serious eye disorder cases reported in India, with the goal of raising awareness about the risks of early-life or accidental exposure. A retrospective, post-market observational study was conducted using data collected from VigiBase® until March 2025, using mapped terms under Medical Dictionary for Regulatory Activities (MedDRA). Among 2,664 global cases of minoxidil-suspected infantile hypertrichosis, 45 involved children aged 0–23 months: 22.2% due to maternal exposure, 44.4% accidental, and 33.3% unknown. No cases were reported from India. A total of 1,669 global cases among the general population involved eye disorders, with 25 from India. Common symptoms included eyelid oedema, blurred vision, and central serous chorioretinopathy (CSCR). Of 9 serious cases, 4 remained after de-duplication (3 CSCR, 1 retinal artery occlusion). Minoxidil, though effective for adult alopecia, poses risks of adverse events in children and potential eye disorders in others. Caregiver education and counselling are essential to prevent accidental exposure. Stricter regulations on dispensing and clearer usage guidelines are needed to curb misuse and misinformation.