Drug mix-up leads to 'werewolf syndrome' in Spanish babies

Angela Martínez holds her son Uriel as they walk in a park in Granada. Uriel's body is covered in hair due to taking a ...
Angela Martínez holds her son Uriel as they walk in a park in Granada. Uriel's body is covered in hair due to taking a hair-growing medicine containing minoxidil, wrongly labeled as omeprazole. (AP Photo/Sergio Ruiz) 

MADRID At least 17 children in Spain developed a form of "werewolf syndrome" after they were given medication intended to treat heartburn that was actually used to stop hair loss.

The children who took the mislabeled medicine, some of them babies, began growing hair all over their bodies, a rare condition known as hypertrichosis, Spain's health minister said Wednesday.

The minister, María Luisa Carcedo, said that a Spanish laboratory, Farmaquimica Sur, had erroneously distributed to pharmacists minoxidil, a drug that helps fight baldness, that was labeled omeprazole, a drug that treats acid reflux.

AP/ Sergio Ruiz
AP/ Sergio Ruiz 

The pharmaceutical company, which is based in the southern city of Málaga, got its supplies of omeprazole from India, according to health inspectors quoted by local news outlets. But there is no evidence that the problem originated there or that it went beyond the mislabeling that occurred in Spain.

The laboratory was eventually shut down and the medicine taken off the market. Officials have opened an investigation.

Carcedo, the health minister, told reporters that no pharmacy in Spain still had the mislabeled omeprazole.

"We have immobilised all the batches," she said.

A Farmaquimica Sur employee reached by phone, who declined to give her name, said that company executives were meeting with lawyers to review the situation. The company did not give details about how the medicine was mislabeled.

The heartburn medicine is normally prepared by a pharmacist, who mixes compounds that are distributed in bulk.

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The Health Ministry said that 17 children affected so far were in three regions of the country: Cantabria in the north, Andalusia in the south and Valencia in the east. The public prosecutor of Cantabria has opened an investigation, and some families there have filed criminal lawsuits against Farmaquimica Sur.

The Spanish dermatology association said that the unwanted hair should start to fall out about three months after the children stop taking the drug. But the mother of a 26-month-old girl told El Mundo that even though her daughter had stopped taking the medicine in May, the girl was still covered in unwanted hair.

The woman, who was identified only by her first name, Amaya, said she had taken the infant to a doctor because she started growing hair on her face, which then spread to other parts of her body. The woman said her daughter had been given about 7 milliliters of a syrup thought to be omeprazole.

Photo: AP/Sergio Ruiz)
Photo: AP/Sergio Ruiz) 

For minoxidil, the recommended dose is about 2 milliliters a day. The drug was developed to help reduce hypertension, but has also been used to treat baldness since the 1980s.

The mother told El Mundo that she believed that Spanish authorities were minimizing the importance of the health scandal.

"Thank God that the symptom was as noticeable as hair excess," she said. "If it had been a latent thing that was gradually affecting internal organs, she would have certainly continued to take" the wrong medicine.

The New York Times