Parents are being warned not to give their children a common over-the-counter allergy medication as it could cause hallucinations and intellectual disability.
The Therapeutic Goods Administration issued a safety alert on Tuesday for the oral antihistamine promethazine hydrochloride, which is sold as Phenergan.
‘Promethazine hydrochloride (Phenergan) should not be given to children under six,’ the TGA wrote.
Following an investigation into the drug, the TGA found children under six were at risk of psychiatric and central nervous system side effects if given Phenergan, including hyperactivity, aggression and hallucination.
If given high doses, children were also at risk of experiencing difficulties in learning and understanding, such as reversible cognitive deficit and intellectual disability.
Phenergan is used to treat a range of conditions including allergies, hay fever, and nausea, as well as for short-term sedation.
It is sold over the counter at pharmacies and chemists across the country.
The TGA said Phenergan’s consumer medicine information documents and product labels have been updated.
The Therapeutic Goods Administration (TGA) issued a safety alert for the oral antihistamine Phenergan not to be given to children under the age of six
The TGA explained children who were given high doses were at risk of experiencing difficulties in learning and understanding, including reversible cognitive deficit and intellectual disability
There are close to 50 other brands of oral promethazine hydrochloride on the Australian market.
The brands are all required to update the drug’s product labels, Product Information and Consumer Medicine Information to include the latest risks to children.
Australians are able to purchase the oral antihistamine over-the-counter on the advice of pharmacists.
