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On April 16, Amaya asked the pediatrician for an appointment because her daughter, OC, 22 months old then, had hair on her face. «He asked us if there was someone in the family who was very hairy or if he had been able to take any medication from my parents. We said no; my husband does not have a single hair on his back as seen in the photo », Amaya explains to the phone from Colindres (Cantabria), where she resides.
His daughter's is the first case that came to the Patient Advocate association of babies affected by hypertrichosis - excessive hair growth - after taking a syrup dispensed as omeprazole but actually containing minoxidil, an active ingredient used to treat alopecia . Mediately, the case has been baptized as "babies with werewolf syndrome" because of the similarity of the appearance of children with whom they suffer from this genetic disorder. According to the Spanish Agency of Medicines , there are 17 affected: 10 in Cantabria, four in Andalusia and three in the Valencian Community.
"He began to grow the hair on his face and then progressively increased and spread throughout his body," Amaya continues the story of what happened to his daughter. A month after the visit to the pediatrician, on May 15, he went to the digestive specialist who treated the girl for a gastroesophageal reflux problem. He had been prescribed omeprazole and was taking it from the first month of life. Babies are not given the capsule presentation that is prescribed to adults, but rather a masterful syrup formula, which Amaya was prepared in her pharmacy following the doses set by the pediatrician. «When we told the digestive the hair problem told us that he had just met with a child endocrine colleague from Valdecilla [the hospital in Santander ], and that he had commented on the case of four children from Corrales who had come out hair on the face and they were taking omeprazole. He told me: "This must be the omeprazole. Stop giving it to him and keep the bottle in the fridge, which I am going to ask to take to the Health Ministry to analyze it" », says Amaya.
The parents of the four children of Los Corrales mentioned denounced and the Prosecutor's Office of Cantabria opened an investigation in early August. It is the most affected community, with 10 cases.
On May 23, the Ministry of Health collected the bottle of the alleged omeprazole and analyzed its contents. A month later, Amaya received the call from her pediatrician: «The counseling already had the results and they had discovered that what we had been giving our daughter without knowing it was not omeprazole, but minoxidil, a hair growth that is administered to patients with alopecia ».
Minoxidil was used in principle to treat cases of hypertension, but, after verifying the growth of the hair of those who took it, it began to be marketed in the 80s to stimulate hair growth. Its use is usually topical and, according to its leaflet, the recommended dose is two milliliters -12 sprays- a day. "My daughter was taking seven millimeters and ingested," says Amaya.
By the time they informed him of the results of the analyzes, the Spanish Agency for Medicines and Health Products (AEMPS) had already issued -July 11- a pharmaceutical alert. Minoxidil erroneously distributed as omeprazole came from Farma-Química Sur , based in Malaga, which in turn had acquired the active substance from the manufacturer Smilax Laboratories Limited , based in India. AEMPS ordered the withdrawal of several affected lots that it extended to other items on August 6 when new cases were known. He also suspended the license to Farma-Química Sur to produce or distribute any active substance.
"Once the treatment with the master formulas containing minoxidil instead of omeprazole can be expected, spontaneous reversal of hypertrichosis can be expected," AEMPS said in its briefing on the case. The same reassuring message - "he will leave in a month" - the doctors were transferred to Amaya, but three and a half months after stopping the syrup, the girl has the same hair. Its current appearance is that of the photographs.
The dermatologist who treats her and other Cantabrian babies has suggested a laser treatment if the hair does not remit. "But we don't want to subject the girl to more Jews," says Amaya, who underlines the psychological damage that hypertrichosis is causing them. «When we have taken her for a walk and taken to the park to play, older children and their parents have pointed her out and made comments like" poor, looks like a monkey "," what a hairy child! ". And in spite of how small it is, he already realizes everything and we, his family, more, ”he said in the letter he sent to the Patient Advocate on July 30. This association sent a request to the State Attorney General to open an "ex officio investigation in the face of the serious situation."
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