The Pharmacovigilance Center of Navarra has detected 11 cases, one of them in the Autonomous Community, of hypertrichosis, known as ‘werewolf syndrome’, in infants whose caregivers were using a medication to treat alopecia. Hypertrichosis is the appearance of unwanted hair in areas other than the scalp, including facial hair growth in women.
This is indicated in its October newsletter in which it states that, In April 2023, he became aware of a case that occurred in Navarra of a nursing baby who had progressively developed increased hair on his back, legs and thighs over two months. Pathologies or other medications administered to the baby that could justify the increase in body hair were ruled out.
In the interview with the family it was detected that the father used 5% minoxidil topically for the treatment of androgenic alopecia and for a month she had been on leave from work to take care of her son. After withdrawal of contact with the medication, there was a complete regression of symptoms.
As a result of this circumstance becoming known, a review of the similar cases reported in the database of the Spanish Pharmacovigilance System (FEDRA) was carried out, detecting six additional cases with the same characteristics, all of them in nursing babies whose caregivers were being treated with topical minoxidil for the treatment of androgenic alopecia.
The search was expanded to similar cases reported in Eudravigilance (European pharmacovigilance database) and three additional cases were found. A review of the literature provided one more case.
The Pharmacovigilance Center of Navarra handles the hypothesis that there is a minoxidil transfer from adults who use this medication topically to the young babies in their care and that, when transferred, the drug is absorbed topically or orally (by “pacifying”) producing a systemic effect in children.
“The skin of young children is more permeable due to the lower thickness of their stratum corneum and they have a greater surface area/body weight ratio. For this reason, they have an easier time absorbing topically administered drugs systemically,” he explains.
“It’s serious”
In this report, the Pharmacovigilance Center of Navarra warns that the appearance of generalized hypertrichosis in infants due to accidental exposure to minoxidil “is serious” because “a person is exposed to a medication, which is not the patientof a vulnerable age group and for which said medication is not indicated.
Furthermore, the appearance of hypertrichosis in children “can be alarming and entail the performance of numerous laboratory and imaging tests to rule out endocrine problems, since the initial study of the origin of hypertrichosis can focus on the patient’s own causes. This can generate a great stress on patients’ families.
With all the information collected and following the signal generation procedure of the Spanish Pharmacovigilance System (SEFV-H), in May 2023 the Pharmacovigilance Center of Navarra proposed this signal of hypertrichosis in infants due to accidental exposure to minoxidil for validation within the SEFV-H Technical Committee. The signal was unanimously validated and confirmed in the European Union in June 2023.
For its part, the European Pharmacovigilance Risk Assessment Committee (PRAC), at its meeting in June 2024, issued the recommendation for inclusion in the technical sheet and a warning leaflet about these cases of hypertrichosis in infants after skin contact with the minoxidil application sites in caregivers who used topical minoxidil.
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