Risk of aggression, hallucinations prompts warning against popular medication for kids
Australia’s medicines watchdog says parents ‘shouldn’t be filled with guilt’ about giving their kids Phenergan, a popular hay fever and nausea medication, but stressed they should stop giving it to those under six.
It’s a common drug that’s easily accessible and used to treat hay fever and nausea, especially in children.
Australia’s medicines watchdog has now issued an urgent safety alert, advising that Phenergan not be given to children aged under the age of six because of the risk of psychiatric and central nervous system side effects including hyperactivity, aggression and hallucination.
The same advice goes for other medications containing promethazine hydrochloride.
“When high doses are given, these children may also experience difficulties in learning and understanding, such as reversible cognitive deficit and intellectual disability,” the Therapeutic Goods Administration said in a statement.
The president of the Australian Medical Association, Danielle McMullen, said parents who had previously given the medication to their children “shouldn’t be filled with guilt or distress” about that decision, but should also not continue to give it to children under six years.
“It works as an antihistamine and most of the time is quite sedating but in kids in particular you can sometimes have this opposite reaction – it can actually have the opposite effect where it can make them aggressive and lead to hallucinations,” Dr McMullen said.
The alert aligns with reactions that patients have registered with the government’s Database of Adverse Event Notifications. It showed about 5 per cent of adverse events registered with it were in children aged between five and 11 years, while 4.34 per cent were recorded in children aged under five.
Inclusion on the database does not mean the adverse event is confirmed or caused by the medicine, but it does provide potential insights. Multiple side-effects on the database describe children experiencing confusion, insomnia, tremors, aggression, and hallucinations.
Dr McMullen said Phenergan should also not be used off-label. “Gone are the days when we should be giving kids a Phenergan on a long car ride,” she said.
The TGA said its advice was prompted by an investigation “and advice from our Advisory Committee on Medicines”. It said the advice was applicable to drugs containing oral antihistamine promethazine hydrochloride which is sold as Phenergan and around 50 other brands including generics.
The TGA said health professionals should be alert to the updated advice and counsel parents and carers who may intend to give Phenergan or another oral promethazine product to a child under six years of age.
After being informed of the TGA’s findings, pharmaceutical company Sanofi-Aventis Healthcare, which manufactures Phenergan, requested the updated advice to appear in product information and consumer medicine information leaflets and product labels for the drug. However, it will likely take some months before it appears in packaging on shelves.
The medicine is available to patients over the counter on advice from pharmacists. The Pharmacy Guild of Australia said it had communicated the updated advice to its members.
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