Parents are warned not to give their children over-the-counter allergy medications, as they could cause hallucinations and intellectual disability.
The Therapeutic Goods Administration issued a safety alert Tuesday for the oral antihistamine promethazine hydrochloride, sold as Phenergan.
“Promethazine hydrochloride (Phenergan) should not be given to children under six years of age,” the TGA wrote.
Following an investigation into the drug, the TGA found that children under six years of age were at risk of psychiatric and central nervous system side effects if given Phenergan, including hyperactivity, aggression and hallucinations.
If given high doses, children were also at risk of experiencing learning and understanding difficulties, such as reversible cognitive deficits and intellectual disability.
Phenergan is used to treat a variety of conditions, including allergies, hay fever, and nausea, as well as for short-term sedation.
It is sold without a prescription in pharmacies and drugstores throughout the country.
The TGA said Phenergan’s consumer medicines information documents and product labels have been updated.
The Therapeutic Goods Administration (TGA) has issued a safety alert for the oral antihistamine Phenergan which should not be given to children under six years of age.
The TGA explained that children who received high doses were at risk of experiencing learning and understanding difficulties, including reversible cognitive deficits and intellectual disability.
There are about 50 other brands of oral promethazine hydrochloride on the Australian market.
All brands should update the drug’s product labels, product information, and consumer drug information to include the latest risks to children.
Australians can buy the oral antihistamine without a prescription following the advice of pharmacists.