A mix up at a pharmaceutical company in Spain has resulted in at least 17 babies being accidentally administered a common hair loss treatment.
The young children were all being treated for heartburn or acid reflux with what they believed to be omeprazole. However, El Pais newspaper reports that, due to an error at the Farma-Quimica Sur factory, the liquid drug turned out to be minoxidil.
Babies developed hypertrichosis
When applied topically to the scalp, this medication promotes hair growth; it is the only unisex treatment for the most common form of hair loss, androgenetic alopecia – Male Pattern Baldness and Female Pattern Hair Loss – that is both licensed by the MHRA and FDA-approved.
As with any medication, the accompanying patient information leaflet for high strength minoxidil products should clearly state that the medication is not suitable for children and should be kept out of their reach.
The authorised minimum age requirement for this hair loss solution is 18 years old, yet this mistake saw it being given to young babies, with two known to be aged three and six months.
This had lead to 17 diagnosed cases of generalised hypertrichosis, also known as ‘werewolf syndrome’, in babies across Cantabria, Andalusia and Valencia by Tuesday 27th August 2019.
This rare condition causes excessive hair growth not just on the scalp, but also all over the face and body. Although similar, it differs from hirsutism in that hirsutism only affects women.
It causes surplus terminal hair growth only in androgen-dependent areas, such as the scalp, armpits and legs, whereas hypertrichosis can present as profuse hair growth in any or all areas of the head and body where follicles are present, regardless of whether they are androgen-sensitive or not.
Minoxidil’s hair growth accelerating properties were, in fact, initially discovered when patients using the vasodilator in its original, oral tablet form to treat high blood pressure started developing hypertrichosis.
Whether the babies who have been affected by this pharmaceutical scandal have been checked for any potential heart-related issues is not mentioned in the report. Some of the mothers quoted do mention their children’s doctors have said there should be no significant impact, although one does mention her baby is still experiencing liver issues as a result.
Mis-labelled as acid reflux medication
According to an anonymous source from the Spanish Agency of Medicines and Medical Devices (AEMPS) quoted in the El Pais article, the error came when a bulk shipment of omeprazole from India was divided into smaller bulk batches, which were later sold in pharmacies across Granada.
One, with the lot number 11072/10/42 turned out to be minoxidil mis-labelled as omeprazole.
“There was a serious confusion in the process. It’s not that omeprazole was mixed with minoxidil, but rather that the package leaflet said one thing and the pharmacy another,” they told the newspaper.
This incident was initially reported to the AEMPS in July and many – though not all – of the products have since been recovered and taken off sale. Farma-Quimica Sur has also been banned from “manufacturing, importing or distributing pharmaceutical active ingredients” since the problem was uncovered. It has been given six months to present a plan to rectify the problems identified during the regulatory agency’s investigation.
Whilst the babies’ extra hair has started shedding, it may take months for it all to fall out, and four families have launched criminal proceedings against the company as a result of the findings.
The Belgravia Centre is an organisation specialising in hair growth and hair loss prevention with two clinics and in-house pharmacies in Central London, UK. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the world. View our Hair Loss Success Stories, which includes the world’s largest gallery of hair growth comparison photos and demonstrates the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time to arrange a free consultation.