Some newborn babies have developed an ultra-rare condition known as "werewolf syndrome" following a major mess up with drug labeling.
The Spanish Agency of Medicines and Health Products (AEMPS) confirmed earlier this month that at least 13 babies have developed "werewolf syndrome" in Spain over the past summer. That number has risen to 17 in recent days. According to the Spanish newspaper El País, 10 babies have been affected in Cantabria, four in Andalusia, and three in the Valencian region.
The syndrome is medically known as hypertrichosis, a condition characterized by an abnormal amount of hair growth. Although some cases are relatively mild, it can result in long hair growing all over the body and face, hence the nickname “werewolf syndrome”.
The babies were given a syrup containing omeprazole, a drug used to treat colic by decreasing the amount of acid produced in the stomach. However, an analysis by AEMPS found that the formula also contained considerable levels of minoxidil, a medicine used for the treatment of alopecia and male-pattern balding by stimulating hair growth.
Hypertrichosis is incredibly rare with less than 50 cases officially documented worldwide. The cause of hypertrichosis is unclear, although it's thought to be associated with a genetic disorder, malnutrition, the presence of a malignant tumor, or – like this case – the effect of a drug.
So far, it looks like excessive hair growth is the only consequence of the drug; however, the affected babies will have to receive further medication evaluations until they’re given the all-clear.
Official AEMPS documents show that the Málaga-based pharmaceutical company Farma-Química Sur bought at least 22 of the tainted lots from Smilax Laboratories Limited in India. While the drug has since been withdrawn from circulation, authorities are now investigating whereabouts in the supply chain this mishap occurred.
“The original shipment of bulk omeprazole from India was analyzed and the results showed that it was in perfect condition. The problem was when it was divided into small batches that were later also sold in bulk. There was a serious confusion in the process,” an unnamed source from AEMPS told El País.
“It’s not that omeprazole was mixed with minoxidil, but rather that the package leaflet said one thing and the pharmacy another.”