Omeprazole is a medicine used in pediatrics for gastroesophageal reflux disease (GERD), always prescribed by the doctor. A contaminated batch of this medicine has affected at least 17 babies with hypertrichosis, a rare disease that causes excess hair throughout the body.
After their administration, the parents noticed a significant growth of hair in parts of the body of their babies, especially in the area of the forehead, something that caught their attention and communicated to doctors and pharmacists.
Several cases were registered in Cantabria in July, where four families denounced and the Prosecutor's Office has opened an investigation, and also in the province of Granada, where "22 pharmacies have received potentially affected product," as reported by the Ministry of Health to Granada Today .
Health alert
The AEMPS (Spanish Agency for Medicines and Health Products) announced on August 8 the withdrawal of 23 batches of the omeprazole drug from India and distributed by Farma-Química Sur, a Malaga company that is currently prohibited from selling the product, after detecting which contained Minoxidil, an active substance used for the treatment of alopecia.
In Babies and more My baby regurgitates, what can I do?It all started in July, when the Spanish Pharmacovigilance System for Medicinal Products for Human Use (SEFV-H) received notification of 13 cases of hypertrichosis (excess hair) in children associated with the use of master formulas made with lot 11072/10 / 42 of the active substance omeprazole.
Subsequently, he received notification of a new case of hypertrichosis associated with a master formula made with another batch, 11072/10/41, and after his analysis the existence of minoxidil was also confirmed.
Affected cases have led the State Agency of the drug to request withdrawal of all omeprazole items They are currently being analyzed. The results of the analyzes should determine how many batches are affected and at what point in the process the active substance of the omeprazole that the babies ingested was contaminated.
In Babies and more15 pregnant women affected by an outbreak of listeriosis in Andalusia: a very dangerous infection for the babyWhat happens if my baby has taken Omeprazole?
The AEMPS warns that if you have recently taken or administered to a child a master formulation with omeprazole go to your pharmacy to tell you if it is one of the lots affected in Pharmaceutical Alert R_19 / 2019. (check lots here)
If you have observed excessive hair growth after taking the medication, see a doctor.
Discontinued treatment, hypertrichosis in infants should reverse spontaneously, but families are concerned that there may be other side effects associated with contaminated omeprazole.
