Urgent warning to parents over common drug that could cause intellectual disability in children
Parents are cautioned not to give their children commonly over-the-counter allergy medications because they can cause hallucinations and intellectual disability.
The Therapeutic Goods Administration issued a safety alert Tuesday for the oral antihistamine promethazine hydrochloride, which is sold as Phenergan.
“Promethazine hydrochloride (Phenergan) should not be given to children under the age of six,” the TGA wrote.
Following an investigation into the drug, the TGA found that children under the age of six were at risk of psychiatric and central nervous system side effects when given Phenergan, including hyperactivity, aggression and hallucinations.
When children received high doses, they were also at risk of experiencing problems with learning and understanding, such as reversible cognitive impairment 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 without a prescription at pharmacies and pharmacies across the country.
The TGA said Phenergan’s information documents and product labels for consumer medicines have been updated.
The Therapeutic Goods Administration (TGA) has issued a safety alert for the oral antihistamine Phenergan that should not be given to children under the age of six
The TGA explained that children given high doses were at risk of experiencing difficulties in learning and understanding, including reversible cognitive impairment and intellectual disability.
There are almost 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 drug information to include the latest risks to children.
Australians can buy the oral antihistamine without a prescription on the advice of pharmacists.