A pharmaceutical mishap has led to a heart-wrenching outcome as 17 babies in Spain are born with hypertrichosis, commonly known as werewolf syndrome, due to a medication error. The incident is attributed to Farma-Química Sur, a pharmaceutical company in Málaga, which mistakenly supplied a vasodilator drug used to treat alopecia as omeprazole, a medication for gastric issues.
The grave internal error led to minoxidil, a potent vasodilator prescribed for alopecia, being sold under the guise of omeprazole. This error resulted in the affected infants developing hypertrichosis, causing excessive hair growth on various parts of their bodies.
The emotional toll on affected families has been immense. Ángela Selles, mother of Uriel, one of the affected babies, shared her distressing experience as her son developed excessive hair on his forehead, cheeks, arms, legs, and hands. The condition gave him the appearance of an adult, causing considerable concern and confusion.
Reports suggest that 17 cases have been registered so far, with minors affected across various regions in Spain. Doctors’ reports alerted the Spanish Agency for Medicines and Health Products (Aemps) about the unprecedented cases, prompting investigations into the matter.
The source of the problem was traced to syrups used to treat gastric reflux, sold to parents under the assumption of being master formulas from certain pharmacies. Aemps inspectors discovered the mistake when analyzing batches of the medication, revealing that the package insert incorrectly labeled minoxidil as omeprazole.
The repercussions of this error have been devastating. Werewolf syndrome, characterized by excessive hair growth all over the body, has caused distress and confusion among the affected families. While steps have been taken to address the issue, the consequences of this medication mix-up continue to unfold.
The Aemps published an alert on July 11, acknowledging the situation, but further cases of hypertrichosis emerged, leading to an extended alert covering 22 batches of medications on August 6. In response, the factory responsible for the error was closed for failing to adhere to drug manufacturing control regulations.
“We went to the pediatrician and she told us that it could be something generic or metabolic. We had to start going to specialists to rule out ʋseveral syndromes and very гагe conditions, ”she declared before a medіа outlet.
If approved by the inspectors, the factory will be able to resume operations. Otherwise, your authorization to ргoduce pharmaceutical ргoducts will be annulled.
Αccording to doctors, the hair that has grown on the body of children саn take many months to disappear. Some patients have had liver problems.
The factory has been given a six-month window to respond to the report submitted with the errors, outlining corrective measures. However, if the company fails to meet the requirements, their authorization to produce pharmaceutical products may be revoked.
The aftermath of this tragedy is still unfolding, with affected children likely to carry the burden of excessive hair growth for months. Some have even experienced liver problems. As the investigation continues, doctors are keen to understand the potential impact of the minoxidil exposure on the young patients.
The severity of the incident has led to legal actions. The Cantabria Prosecutor’s Office initiated an investigation in August following criminal complaints from four families.
In the face of this unforeseen tragedy, it is crucial to share the details of the event to raise awareness and advocate for the affected families. Continuous reporting on the case will shed light on the progress made in addressing this heart-wrenching mishap.
