A recent investigation has unveiled significant concerns surrounding the use of unapproved medicinal cannabis in Australia, with over 615 adverse events reported to the Therapeutic Goods Administration (TGA) in just three years. This includes alarming statistics, such as more than 50 reports of psychosis and 14 instances of suicidal thoughts and behavior, according to data obtained through a Freedom of Information request.
The TGA’s report, which covers incidents up to June 2025, highlights a growing issue as many individuals do not report adverse events. Consequently, the actual figures may represent a substantial undercount of the risks associated with these products. Earlier research has documented a rise in calls to Australia’s largest poisons information center regarding cannabis poisoning, particularly affecting children since the legalization of medicinal cannabis.
Understanding the Risks of Unapproved Cannabis Products
Medicinal cannabis products in Australia are largely unapproved, meaning they have not been evaluated for quality, safety, or effectiveness by the TGA. Currently, there are over 1,000 unapproved medicinal cannabis products available, which individuals often use for conditions lacking strong evidence of efficacy. This situation contrasts with the two approved products that require manufacturers to provide substantial evidence of their benefits.
Legalized in 2016, the use of medicinal cannabis surged in 2021 when access to unapproved products was simplified. Notably, young men have been the fastest-growing demographic among users, with approximately one-third of prescriptions for anxiety. This trend continues despite TGA guidelines indicating that cannabis containing THC (tetrahydrocannabinol) is generally unsuitable for patients with a history of psychotic disorders or active mood conditions.
Concerns regarding the link between cannabis use and mental health issues extend beyond Australia. A significant Canadian study revealed that cases of schizophrenia associated with cannabis use nearly tripled following legalization reforms. In Australia, reports of first-time psychosis related to medicinal cannabis have also emerged, raising alarms among health professionals.
Child Poisonings and Calls for Increased Regulation
The dangers of cannabis extend to children, with unintentional poisonings rising sharply since the introduction of legal cannabis products. Data reveals that concentrated cannabis oils and edibles have led to an increase in poisoning cases, particularly among children who are inadvertently exposed. These products often resemble regular food items and can pose a serious risk, resulting in severe health complications such as seizures or comas.
The Australian Health Practitioner Regulation Agency has raised concerns regarding the prescribing practices associated with medicinal cannabis, particularly regarding “single-purpose dispensaries” that rely on telehealth to issue prescriptions. Some practitioners have reportedly issued over 10,000 medicinal cannabis scripts within a six-month timeframe, prompting calls for stricter oversight and best practices in prescribing.
To address these growing concerns, the TGA is currently reviewing the regulatory framework governing access to unapproved medicinal cannabis products. This consultation may lead to significant changes in an industry that has rapidly expanded without adequate oversight.
For individuals considering medicinal cannabis, consulting a regular general practitioner or specialist is crucial. A comprehensive assessment should be conducted to evaluate risks, benefits, and potential drug interactions based on personal medical history. If prescribed medicinal cannabis, it is vital to store it securely, out of reach of children.
Anyone facing issues related to cannabis use or concerned about someone else may contact Lifeline at 13 11 14 for support.
As the landscape of medicinal cannabis continues to evolve, ongoing scrutiny and research will be essential to ensure patient safety and public health.
