The Spanish Agency of Medicines and Health Products (AEMPS) has ordered the withdrawal of a batch of omeprazole , for babies, defective that caused hypertrichosis , an excess of hair that has affected fourteen babies of Andalusia by the drug, distributed in about thirty Pharmacies

This prescribed principle for infants with reflux has caused hypertrichosis in at least fourteen children under one year of age in Andalusia, sources from the Ministry of Health have confirmed.

According to the alert of the Spanish Agency of Medicines, the defective omeprazole because it contains minoxidil, an active principle of medicines for alopecia , has been detected in 22 lots with a withdrawal order.

This pharmaceutical alert is in addition to the one issued last July 11, when the withdrawal of a batch of this same drug was ordered after thirteen cases of hypertrichosis were diagnosed in different provinces in the north of the country and all for drugs made with the active substance of Farmaquímica Sur SL, located in Málaga.

According to the General Council of Pharmaceutical Colleges, the company responsible for the manufacture of the drug has calculated that the defective product has been distributed to between 24 and 30 Andalusian pharmacies.

The laboratory has also pointed out that it is directly contacting each of them and treating each case in a personalized way.

Cases in Santander

This pharmaceutical alert is added to the one published in July also by an omeprazole prescribed for the reflux of babies and that caused them hypertrichosis.

In that case, the parents of four children in Santander denounced a laboratory, importing and distributing companies of medicines and two pharmacies for manufacturing, distributing and selling a product with crepelle that were supplied by mistake to their babies, to which they prescribed Omeprazole

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