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.
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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.
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.
The chair of the Australian Medicinal Cannabis Association, lawyer and scientist Teresa Nicoletti, said the adverse event data was "not cause for concern" by itself.
"The percentage of adverse events are really rare compared to the number of units that have been actually sold with medicinal cannabis," she said.
"If we look at the data, which we have been provided by the Pennington Institute, it's probably around 13 million units sold in that period."
Dr Nicoletti said she would welcome adverse event reports being routinely published on the TGA's public database.
However, she said the causes of an event needed to be established before conclusions could be made about the safety of medicinal cannabis.
"When you start to look at a lot of the adverse events for which information is available, medicinal cannabis was not the only medicine that was prescribed," she said.
"So, it's very difficult to pinpoint what the actual cause of the adverse event was in those cases and particularly where the medicinal cannabis was associated."
Psychiatrists say companies prioritising profit over safety
Chair of the Queensland branch of the Royal Australian and New Zealand College of Psychiatrists (RANZCP) Brett Emmerson believed the 615 adverse events reported between July 2022 and June 2023 were the tip of the iceberg.
Last year, Professor Emmerson told the ABC his colleagues had seen a significant increase in people hospitalised with psychosis after being prescribed medicinal cannabis.
"The industry continues to market medicinal cannabis for a wide variety of conditions for which there is no evidence that it works," he said.
"They market it because people take it and that's their business.
The medicinal cannabis companies are just like the tobacco companies — they want people to use their product, that's how they make their money and their profit."
Professor Emmerson is calling for greater regulatory oversight of medicinal cannabis.
He said companies should be required to prove specific products were safe and effective treatment for conditions before the medication could be prescribed.
"This is not a drug that can be just regarded as a natural product," he said.
"It's a drug of dependence with serious side effects and it's having a tragic impact on a large number of people in this country."
Safety review now underway
Last month, the TGA announced a review into the safety and regulatory oversight of unapproved medicinal cannabis products after being contacted by the ABC.
In its consultation paper, it said 24 per cent of all adverse events associated with medicinal cannabis products since 2016 were considered "serious" by the submitter.
The TGA said it was "highly likely" there was considerable under-reporting of adverse events due to stigma, and concerns over losing access.
"This consultation … has been prompted by increasing public and professional concern about the safety risks associated with unapproved medicinal cannabis products, particularly those containing higher levels of tetrahydrocannabinol (THC)," the TGA said.
"These concerns include a reported increase in patients presenting to health services with a range of mental health issues including psychosis and dependency following the use of medicinal cannabis products."
The TGA said it "shares these concerns and supports the call for regulatory change".
"The TGA seeks to understand whether current regulatory arrangements that enable patients to access medical cannabis … provide adequate oversight for the more than 1,000 unapproved products currently supplied in Australia," it said.
System needs change, health bodies say
Australian Medical Association (AMA) president Danielle McMullen welcomed the TGA's review, and said medicinal cannabis was "being prescribed at alarming rates through direct-to-consumer telehealth models".
"Clearly, the health landscape has changed dramatically in Australia, so it is vital we look at our regulatory settings and find out what needs to be done to address any gaps, including in the medicinal cannabis space," Dr McMullen said.
"We are seeing increasing reports of patient harm from cannabis, including psychosis, so this current surge in prescriptions is highly concerning.
"This is despite the reality there is very little evidence to support the use of medicinal cannabis other than in a small number of conditions."
The AMA, RANZCP and AMCA agreed the current systems that allowed doctors to prescribe cannabis, the Authorised Prescriber and Special Access Schemes, were not fit for purpose.
However, they have disagreed on the exact pathway forward.
Dr Nicoletti said more discussion with the medical cannabis industry was needed, but suggested a notification scheme, where clinicians provided information about their prescribing to authorities, be established.
"This regulatory framework is crying out for an access pathway that has less administrative burden and considers the issues around regulating medicinal cannabis safety and quality," the AMCA chair said.
The RANZCP wants medicinal cannabis products to undergo the same strict registration process as other medicines, to allow their quality, safety and effectiveness to be assessed.
"Greater regulatory oversight is essential," Professor Emmerson said.
"A registered drug will be tested. We'll know the safety requirements and there will be hopefully a lot more monitoring of the of the product."
Written by Matilda Marozzi, ABC News.
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