By MAIYA FOCHT HEALTH REPORTER FOR DAILYMAIL.COM
A balding drug used by millions of Americans has been blamed for a spate of cases of ‘werewolf syndrome’ in babies.
Minoxidil – an over-the-counter foam applied to the scalp – caused the infants to develop uncontrollable hair growth across their bodies.
Researchers in Spain who discovered the cases believe it could be caused when parents’ touched their kids soon after using the drug. From there, it may have entered their kids’ mouths or permeated through their delicate skin.
These case studies have caused the European Medicines Agency to suggest additional warnings to their labels about Minoxidil, warning about the risk of hair growth on infants.
The new warning explicitly warns parents that they and their children should not ingest the foam.
The FDA has not publicly commented on these Spanish cases, nor does it appear to be issuing additional warnings about Minoxidil usage.
In all eleven cases, the children’s hair growth ceased and reversed after their parents stopped exposing them to the drug.
Minoxidil isn’t known to be dangerous, but in one case study from France in 2014, an anonymous child who swallowed a teaspoon of the product was sent to the hospital with a dangerously high heart rate and low blood pressure.
Dr. Isabelle Claudet, the head of the pediatric emergency department at Children’s Hospital in Toulouse who authored the 2014 report told Reuters: ‘At therapeutic dosage, there is usually no serious adverse effect, but for a child, some milliliters or a teaspoon can lead to long-lasting hypotension.’
This is because the drug relaxes blood vessels, stimulating blood flow to the hair follicles, and in turn, promoting hair growth.
Beginning in 2023, sets of parents in Spain saw excessive amounts of hair bloom on their young child’s back, legs and thighs over a few months – in a condition known as hypertrichosis.
Officials at the Pharmacovigilance Center of Navarre traced the unexplained hair growth in 11 children back to minoxidil.
Minoxidil is an FDA approved formulation available at a range of concentrations, including 1 percent, 2 percent, 5 percent, 7 percent and 15 percent.
The foams and other topical treatments are generally available over the counter, though it’s more rare to see the higher concentrations, according to the telehealth provider Hims.
There are also pill forms that people can take, but these require a prescription.
It’s unclear how many Americans use some form of the drug, since users can purchase it without a prescription.
But 80million Americans struggle with some form of hair loss as they age, and Minoxidil is one of the most common treatments, according to Cleveland Clinic.
Usually, when the drug is applied to the scalp, it’s affects are isolated to that region.
But in the pill form, the FDA label on the drug notes that it can cause hypertrichosis in the: ‘eyebrows, between the hairline and the eyebrows, or in the sideburn area of the upper lateral cheek, later extending to the back, arms, legs, and scalp.’
The label also notes that the drug has not been used in infants, but does not note that there is any danger in being exposed to the drug.
In the case of the Spanish children, according to Newsweek, authorities report that the children may have ingested the drug from their caregivers scalp or hands, since children often put their mouths on things.
It could also be that skin to skin contact with a person who has Minoxidil on their body could permeate into the skin of the child, since their skin is more delicate than adults and substances can pass more easily into it.
In all 11 cases reported, the children’s excess hair growth began waning once Minoxidil exposure was removed.
These new cases in part prompted the EMA to add new warnings to their minoxidil labels.
In the EU the Product Information must now include: ‘Cases of hypertrichosis have been reported in infants following skin contact with minoxidil application sites of patients (caregivers) using topical minoxidil.
Hypertrichosis was reversible, within months, when infants were no longer exposed to Minoxidil. Contact between children and Minoxidil application sites should therefore be avoided.’
They also added: ‘Do not ingest’.
Older case studies have linked Minoxidil solution to unwanted hair growth.
In 2015, an anonymous 42 year old Spanish woman went in to see dermatologists after mats of thin, soft dark hair began growing like a beard across her face and lower back.
Doctors had prescribed her 5 percent topical Minoxidil to try to treat alopecia – or hair loss- and she had been taking it for two weeks. She said she was careful to avoid letting the solution sit anywhere but her scalp, yet she still saw the hair growth.
Six months after stopping the topical, she began to improve, with the hair thinning on her beard and torso, doctors reported in the journal Academia Espanola De Dermatologia Y Venerologia.
A similar outbreak occurred, again in Spain, in 2019 after a container of Minoxidil pills were mislabeled as acid-reflux medication. 17 children developed werewolf syndrome as a result, but their symptoms seized after they stopped taking the drugs.
Hypertrichosis can be a condition that someone is born with or one that someone develops, according to Medscape. In some cases, the hair grows in isolated areas – like on the tips of the elbows or on the face – in others, the hair grows all over the body.
Each of these scenarios is slightly different than the other, making it difficult for doctors to diagnose or determine a cause for the condition. Doctors aren’t even sure how common it is, but some estimates put it around one in a billion.
It affects people from every country and doesn’t seem to be more common in boys or girls.
Some children who are born with the condition see their excess hair start to thin during adolescence, others live with it for life. Aside from the hair growth, people with the condition lead a normal, healthy life.
Still, there can be psychological consequences of living with the condition, since some people with it are teased for their appearance.
