Labeling Error from Pharmaceutical company lead to develop werewolf syndrome in Children
Almost 17 children were affected with hypertrichosis outbreak or werewolf syndrome due to labeling error by pharmaceutical company in Spain. The company named Farm-Química Sur accidentally sold minoxidil which is most commonly used to treat alopecia as omeprazole a drug used to treat heartburn and acid reflux.
The public prosecutor of Cantabria also opened a case against Farma-Química Sur in August after four families launched criminal proceedings against the company as reported by EL PAÍS
Initially, in July Spanish agency for medicines and health products withdrawn single batch of Omeprazol from Farma- Química Sur SL and later withdrwan all batches from market which are manufactured by Hyderabad based Smilax Laboratories Limited as reported on AEMPS website.
Children have been affected by hypertrichosis, which causes hair growth after consuming the master formula prepared by various pharmacies in Granada and other part of Spain.
Omeprazole is available in capsule form in Spain which cannot be prescribed to pediatrics patients. So, doctors asked pharmacists to make omeprazole syrup for baby when child has reflux. But the defective omeprazole which is mislabeled lead to excessive hair growth in children.
Manuel Fuentes, president of the Official College of Pharmacists of Granada, defended local pharmacies on medical error, reported by Grand Hoy.