What we know about the "werewolf syndrome" that has affected 17 babies and forced to withdraw a batch of contaminated omeprazole

"My son had hair covered his forehead, cheeks, arms and legs, hands ... He had the eyebrows of an adult. It was very scary because we didn't know what was happening to him, ”Angela Selles explained to the newspaper El País. Uriel, who is the name of his son, is one of the 17 babies who have developed the 'werewolf syndrome' due to a failure by a Malaga pharmaceutical company.

According to the Spanish Agency for Medicines and Health Products, Farma-Química Sur put minoxidil, a vasodilator that is often used to treat alopecia, on the market, as if it were omeprazole. The company sells this last active ingredient in bulk so that pharmacies can make syrups and other magisterial formulas that, in small doses, are used in babies with gastric problems. Thus the intoxication occurred.

What is 'werewolf syndrome'?

Despite the striking nature of the name, hypertrichosis (popularly known as 'werewolf syndrome') is an overgrowth of body hair. With the exception of the soles of the hands and feet, people who manifest this condition are covered by long lanugo hair. Sometimes very long.

Congenital hypertrichosis (caused by various genetic alterations) are very rare and, in the medical historical literature, they appear linked to the emergence of some of the popular myths such as the "werewolf". Acquired drugs, on the other hand, are much more common and are usually caused by some cancers, metabolic-hormonal problems or, as in this case, by certain drugs. Minoxidil is one of them.

Actually, in this case, hypertrichosis appears only as a sentinel effect of minoxidil poisoning. The problem is that, as it can be seen in the package leaflets of this medicine, there have not been enough studies of the vasodilator in children to know what the rest of the adverse effects may be.

How has intoxication like this been possible?

AEMPS researchers have already identified the source of the problem. Thanks to the notifications of the Spanish Pharmacovigilance System for Medicinal Products for Human Use, it was quickly identified that the problem was in the syrups against gastric reflux. It was the distribution company (Farma-Química Sur) that, when preparing small batches for sale to pharmacies, made a mistake in labeling by selling one active ingredient like another.

The AEMPS already paralyzed a batch of this company on July 11. After the investigation, the stoppage affected 22 different batches and led to the automatic closure of the factory due to serious breach of the regulations in force.

On the one hand, the AEMPS has paralyzed all the activities of the factory pending the completion of the investigation and the evaluation of whether the errors are rectifiable or not. On the other hand, the Cantabria Prosecutor's Office has announced that it will open criminal proceedings against the company and it is expected that those of the other affected places will follow suit.

Image | Piotr Janus

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