MADRID, Spain: Spanish pharmaceutical company, Farma-Química Sur, is facing trial for their role in an outbreak of extraordinary and unnatural hair growth in 17 babies across the country.
Spanish Agency of Medicines and Medical Devices (AEMPS) revealed that the company accidentally sold a strong vasodilator minoxidil, used to treat alopecia or hair loss, as omeprazole, a drug used to treat heartburn and acid reflux.
“Minoxidil was put into recipients that were labelled omeprazole,” María Luisa Carcedo, the Spanish health minister, disclosed earlier this week.
The drug swap resulted in hypertrichosis, more commonly known as werewolf syndrome,a condition characterized by thicker, denser patterns of body hair instead of the usual finer fuzz.
The condition is usually associated with genetic anomalies at birth. However, in this case 10 babies in Cantabria, four in Andalusia and three in Valencia developed the rare medical anomaly triggered by the baldness drug.
“My son’s forehead, cheeks, arms and legs, hands became covered in hair,” said Ángela Selles, a mother from Granada, whose son Uriel was six months old when his body developed the werewolf syndrome.
“He had the eyebrows of an adult. It was very scary because we didn’t know what was happening to him,” she sadly exclaimed.
Another mother from Granada complained about the “anguish of going from one doctor to another” to look for answers.
“We went to the pediatrician and they told us it could be something genetic or to do with his metabolism. We had to start going to specialists to rule out several syndromes and rare conditions,” she said.
Soon doctors notified the Spanish System of Pharmacovigilance of Medicine for Human Use (SEFV-H) about the first cases of hypertrichosis in babies. AEMPS opened an investigation which led them to a factory called Farma-Química Sur in Málaga, the south of Spain, where they then sent inspectors.
“The original shipment of bulk omeprazole from India was analyzed and the results showed that it was in perfect condition. The problem was when it was divided into small batches that were later also sold in bulk. There was a serious confusion in the process. It’s not that omeprazole was mixed with minoxidil [medication to treat male-pattern hair loss], but rather that the package leaflet said one thing and the pharmacy another,” sources from AEMPS told media.
It was not until July that the labeling error was finally identified. The agency issued its first warning on July 11, which was directed at just one of the batches of omeprazole that Farma-Química Sur had put on the market.
The factory was closed on Tuesday for failing to meet “control standards on drug production,” according to sources.
“Why does it take more than two months to test a medicine?” questioned Amaia, one of the distressed mothers of the affected babies.
“We have been told nothing. I am furious, scared and feel misunderstood and a complete lack of empathy. My daughter was taking seven millilitres a day of this compound, more than the recommended dose even for an adult, and no one has called to tell us what happens now,” she protested on local television.
The case against the manufacturer ‘remains open,’ while the company has been given six months to present a plan to rectify the problems identified by the agency in its deficiency report.
The deadline can be revised if the company decides to present its plan earlier.
Farma-Química Sur can resume operations if AEMPS inspectors approve their rectification plan, otherwise the company shall face annulment of authorization to produce pharmaceutical products.