Thousands of Ozempic scripts written for under-18s, data show

Under-18s are receiving scripts for the blockbuster semaglutide drug Ozempic despite it not being TGA-approved for children or adolescents.

The Department of Health, Disability and Ageing says 625 prescribers wrote 2832 scripts for Ozempic for under-18s between 2020-21 and 2023-24 under the PBS.

Some 1514 scripts were written in 2023-24.

Lack of data means the precise clinical indications for which the drug is being used is largely unknown.

The drug is only PBS-listed for type 2 diabetes, which is rare in children, with only 320 Australians aged under 15 having the condition in 2024.

Paediatric clinical pharmacologist Professor Madlen Gazarian said if children are being prescribed Ozempic off-label for obesity, it should only occur with approval from a paediatric multidisciplinary clinic specialising in weight management.

“I would not be comfortable with off-label use being initiated for a child in a general practice setting,” Professor Gazarian, from UNSW Sydney, said.

“There might be effects on growth and development not seen in adults. We need to balance that risk.”

Professor Gazarian said pharmacologists had repeatedly called for a national system to collect real-world data on off-label medicine use.

If children were receiving Ozempic, the data could be used to study safety and efficacy, she said.

This could also show how many were prescribed Ozempic for weight management compared with type 2 diabetes.

“When widespread non-evidence-based off-label use becomes established, it removes the incentive to conduct the needed research,” she said.

“We’ve seen that happen over and over again with other medicines.”

For example, prescribing quetiapine for insomnia has become widespread despite being off-label, as has baclofen for alcohol use disorder.

Professor Maria Craig, a paediatric endocrinologist and childhood diabetes researcher, said she did not believe there was a significant safety risk with children taking Ozempic.

Based at The Children’s Hospital at Westmead, Sydney, she said clinical trials of other forms of semaglutide in children had shown similar safety outcomes as those seen with adults.

She stressed that international guidelines also recommended GLP-1 receptor agonists for adolescents with type 2 diabetes.

A spokesperson for Novo Nordisk told AusDoc it did not support or promote off-label use of Ozempic.

It stressed it was committed to working with regulators and the medical community “to ensure that any future use in adolescents is based on robust clinical evidence and aligned with public health needs”.

Financial year	PBS Ozempic scripts for children
2020-21	114
2021-22	471
2022-23	733
2023-24	1514

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