The discovery of eleven cases of increased hair in babies whose parents used anti-baldness medications has led to the European Medicines Agency (EMA) to modify the technical sheets and prospectuses of those products to warn of that risk. The decision was adopted in June of this year by the European Committee for Risk Assessment in Pharmacovigilance, as noted in its latest issue of the Pharmacovigilance Information Bulletin of Navarra, which tells the details of the case registered in that community and which launched the process.
In April 2023, the Pharmacovigilance Center of Navarre was aware of a case that occurred in the Foral Community of a nursing baby who had progressively developed increased hair over two months on back, legs and thighs. Pathologies and other medications administered to the baby that could justify the increase in body hair were ruled out.
In the interview with the family, as explained by the Pharmacovigilance Bulletin of Navarra, it was detected that the father of the baby She used 5 percent minoxidil topically to treat androgenic alopecia and had been on leave from work for a month to care for her son. When the child was removed from contact with his father’s medication, there was a complete regression of symptoms.
Minoxidil is a medication used to induce hair growth in patients with alopecia androgenic (baldness). Among the adverse reactions (ADRs) included in the technical specifications of medicines containing minoxidil is hypertrichosis, known colloquially as werewolf syndrome and which consists of the appearance of unwanted hair in different areas to the scalp, including facial hair growth in women.
After detecting this case in Navarra, other similar cases reported in the database of the Spanish Pharmacovigilance System (FEDRA) were reviewed and another six with the same characteristics were detected: breastfeeding babies whose caregivers were being treated with topical minoxidil. The search was expanded to similar cases reported in the European pharmacovigilance database and three additional cases were found, to which another was added in the review of the medical literature: eleven cases in total.
The hypothesis of the Navarra Pharmacovigilance Center is that there is a minoxidil transfer between parent caregivers and infants to your care topically, by furor orally, which produces that veil-increasing effect in children.
After the detection of these cases, the Committee for Risk Assessment in Pharmacovigilance European Union (PRAC) issued a recommendation that Warn of these risks in the technical sheetsleaflets and packaging of minoxidil products.