Translation of a-t 2024; 55: 104
SIDE EFFECTS
HYPERTRICHOSIS IN INFANTS AFTER CONTACT WITH MINOXIDIL APPLIED EXTERNALLY
Two parents presented to a paediatric clinic in Spain. Their four-month-old infant had increasingly thick hair growth on his legs and back for two months. After ruling out disease-related causes with numerous tests including an abdominal MRI and hormonal analyses, suspicion fell on the father: he had been using 5% topical minoxidil (REGAINE, generics) to treat hair loss on his head for two months. After he discontinued use, the hypertrichosis in his son gradually improved and ultimately disappeared completely.1
Seven other reports were also listed in a review published in 2023. They relate to children between three and twelve months old whose fathers or grandfathers started treatment with the hair growth agent. The children developed thick hair on their faces, limbs, shoulders and/or torsos within one to six months. This abated after four to six months with no exposure.2
Topical minoxidil can cause hypertrichosis outside of the therapeutic area even in adults.3 It can be accidentally transferred to children, for example if they are carried on the shoulders of a user for a longer period of time and hold on to the head4 or as a result of contact with the head during hugs.5
There have long been warnings about unintentional transfer of topical medicinal products to children and others through skin-to-skin contact relating to testosterone applied externally (TESTOGEL,6 generics), for example (a-t 2019; 50: 40). In August 2024, the European Medicines Agency (EMA) mandated that the product information for all minoxidil products for external application add a corresponding note.7 Most of the summaries of product characteristics (SPCs) we inspected now indicate that contact between children and the minoxidil application sites should be avoided.8 Users of the preparations, which have been available over the counter since 2005, should be informed of these precautions in a targeted way in order to protect children, –Ed.
| 1 | Prescrire International 2024; 33: 275 |
| 2 | Unidad de Farmacovigilancia del Pais Vasco: Boletin de Farmacovigilancia 2023; No. 57: 4-5 |
| 3 | Johnson & Johnson: SPC for REGAINE, version of July 2023 |
| 4 | FARSANI, T.T.: Pediatr. Dermatol. 2014; 31: 520-2 |
| 5 | MALTONI, G. et al.: Pediatr. Dermatol. 2023; 40: 753-4 |
| 6 | Besins Healthcare: SPC for TESTOGEL, version of November 2024 |
| 7 | EMA: Minoxidil (topical formulation), Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) as of 23 August 2024; https://a-turl.de/sqxh |
| 8 | e.g. Pierre Fabre: SPC for ALOPEXY 5%, version of September 2024 |
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