Drug Labelling error from a pharmaceutical company Farma-Química Sur caused at least 20 babies to develop ‘werewolf syndrome’ and sprout hair all over their bodies in Spain.
The company accidentally sold minoxidil which is most commonly used to treat alopecia as omeprazole a drug used to treat heartburn and acid reflux.
What is drug labelling error?
Drug labeling refers to all the printed information that accompanies with drug, including the label, the wrapping and package insert. The label has two main functions. One is to uniquely identify the contents of the container and other to ensure that patients have clear and concise information which will enable them to take or use their medication in the most effective and appropriate way. If any error occurs it will be considered professional negligence which is defined as absence of reasonable care and skill or willful negligence of medical practitioners in the treatment of patient which causes bodily injury or death of the patient.
What happened here?
In this accident due to drug name labelling error, a syrup which contain minoxidil as ingredient was labelled with drug name omeprazole with indication of acid reflux.
Minoxidil is a hair-growing alopecia medicine and also a vasodilator that relaxes (widens) blood vessels and improves blood flow which is used to treat hypertension.
Minoxidil oral formulations should not be used for scalp hair growth. Only the topical form of minoxidil is recommended for that use. If it is taken orally it can trigger hypertrichosis (often referred to as “werewolf syndrome.” Which is an abnormal amount of hair growth over the body).
Since minoxidil is a drug used to widen blood vessels it could have an impact on organs including the heart, kidneys and liver. Since it was prescribed for acid reflux, infants were taking seven millilitres a day of this Minoxidil which is more than the recommended dose even for an adult and it would never be administered to infants in such doses. The children are aged between a few weeks and two years old.
Omeprazole decreases the amount of acid produced in the stomach hence it is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions caused by excess stomach acid.
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.
The director of Spain’s Agency for Medicines and Health Products (AEMPS) admitted they had become aware of the first cases of babies with hypertrichosis after taking the syrup in May 2019. It was not until July that the labelling error was finally identified, the laboratory shut down and several batches of the medicine recalled.
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