Drug Mistake Causes “Werewolf Syndrome” In 17 Children

A drug mistake at a pharmacy in Spain has resulted in 17 cases of children growing excessive hair on their bodies in an outbreak of hypertrichosis, commonly known as “werewolf syndrome.” The 17 cases were reported by parents in three regions in Spain: Cantabria in the north, Andalusia in the south and Valencia in the east.

All of the children were found to have ingested minoxidil, the active ingredient in hair-loss treatment Rogaine, which was mislabeled as the over-the-counter heartburn medication omeprazole, which is commonly sold in the United States as Prilosec. The Spanish Agency of Medicines and Medical Devices traced the mislabeled medication back to one manufacturer in Spain, Farmaquimica Sur.

According to reports of the investigation, pharmaceutical company, which is based in the southern city of Malaga, got its supplies of omeprazole from India, but indications are that the mislabeling occurred in Spain. A recall was issued and the factory was given six months to fix the issues uncovered in the investigation, or it will have its pharmaceutical-production authorization revoked. Maria Luisa Carcedo, Spain’s health minister, said that no pharmacy in Spain still had the mislabeled omeprazole.

Hypertrichosis, or “werewolf syndrome,” is a rare condition characterized by the excess production of hair, either in one specific area or all over the body. While some people inherit the condition genetically, it can also be caused by the misuse of minoxidil, which can be applied topically or consumed orally. The children affected in this case grew hair rapidly on their forehead, cheeks, arms, and legs. The Spanish dermatology association said that the unwanted hair should start to fall out about three months after the children stop taking the drug.

The public prosecutor of Cantabria has opened an investigation into the matter. Some families there have filed criminal lawsuits against Farmaquimica Sur. An employee of the company, who declined to give her name when reached by phone, said that company executives were meeting with lawyers to review the situation.