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In short:
Despite receiving more than 600 reports of “adverse events” for medicinal cannabis in the past three years, the Therapeutic Goods Administration (TGA) is yet to investigate the safety of most medicinal cannabis products.
Medical and psychiatric peak bodies have called for more oversight.
What’s next?
After questions from the ABC, the TGA announced a review into the safety and regulation of the products.
Australia’s medicines regulator has not investigated the safety of most medicinal cannabis products despite receiving hundreds of “adverse event” reports ranging from coughing to psychosis in the past three years.
The ABC can reveal there were 615 reports made to the Therapeutic Goods Administration (TGA) involving unregistered medicinal cannabis products between July 1, 2022 and June 1, 2025.
It comes amid a surge in use of the products, which can be legally prescribed by doctors despite having an “unapproved” status with the TGA.
More than 50 reports refer to psychosis and 14 instances of suicidal ideation or behaviour, according to data released to the ABC under Freedom of Information laws.
There were also three reports relating to schizophrenia, two of homicidal ideation, one of bipolar disorder and one report of delusion of parasitosis — where a patient wrongly believes their skin is infested with parasites.
An adverse event being reported does not mean the side effect has been confirmed, nor that it was caused by medication.
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A TGA spokesperson said it had the power to investigate unapproved cannabis medications when “safety signals” — red flags for possible safety concerns —were identified.
“To date, no such signals for specific unapproved medicinal cannabis products have been identified and no investigations have occurred,” the spokesperson said.
Following questions by ABC News, the TGA announced it would review the safety and regulation of the products.
The Australian Medicinal Cannabis Association (AMCA) said that without suspected adverse events being published and investigated, it was hard to draw conclusions about the safety of medicinal cannabis products.
There are more than 1,000 different medicinal cannabis products currently available in Australia.
Apart from two products — which are listed on the Australian Register of Therapeutic Goods — the TGA has not approved or assessed any for quality, safety or efficacy.
While health professionals are required to report adverse events for unregistered products, the TGA generally keeps these reports on an internal database used for “general safety monitoring”.
The TGA said when clinicians prescribed an unapproved medicine, they assumed responsibility for the “efficacy and safety of that good”.
Patient ‘shocked’ by lack of oversight
Alice Davy has been using medicinal cannabis since 2020 to help with crippling endometriosis pain and multiple sclerosis.
Ms Davy said medicinal cannabis had been life-changing for her, and prompted her to run for the Legalise Cannabis Party at the federal election earlier this year.
“I’m no longer in debilitating pain. I eat. I sleep. I don’t have any nausea,” she said.
“I’m able to live a full, active life.”
While Ms Davy had never experienced side effects after taking medicinal cannabis, she was “shocked” no investigations had been conducted into reported adverse events.
“We would hope by now, nine years after medicinal cannabis has been legalised, that the TGA would be exploring as to why a very small number of people may be having anxiety, they could be having psychosis,” she said.
“How are we supposed to be able to know what’s safe and what’s not if there’s no tests being done?”
Ms Davy has called for more research into medicinal cannabis, with the hope clinical trials would give Australians the opportunity to safely access the medication.
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Sean Hocking
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