Australia’s medicine safety officials have warned the federal government they are flying blind on the use of puberty blocker drugs for gender-distressed minors.
The country’s first safety assessment of this drug use — revealed in documents obtained under Freedom of Information laws — followed news of the 2024 UK decision to impose an indefinite ban on puberty blockers. This prompted Australian Health Minister Mark Butler to seek urgent advice on the safety of transgender puberty suppression used by children’s hospitals.
But Australia has no official data to show how many children identifying as trans have been given these drugs to suppress the natural sex hormones and interrupt their normally timed puberty, according to the April 22, 2025 report from the safety regulator, the Therapeutic Goods Administration.
This is because these drugs, known as gonadotrophin-releasing hormone analogues (GnRHa), are used “off-label”, meaning they have not been tested for efficacy or safety in the treatment of gender dysphoria or incongruence.
For the same reason, the TGA noted, it was “not possible to assess the risk benefit profile [for this drug use] in the absence of efficacy data [and] it is not possible to calculate rates of adverse events for this indication as we do not have usage information from off-label prescriptions”.
“The efficacy and safety of GnRHas in gender-affirming care has not been assessed by the TGA as the TGA has not approved GnRHas for this indication”, it said.
The TGA safety report noted the UK ban on routine provision of blockers for gender dysphoria rested on advice from the UK’s Commission on Human Medicines of “an unacceptable safety risk”. If the TGA were to discover a new safety concern with puberty blockers for gender distress, it could require updating of the warnings in product information for the drugs, but it could not suspend or cancel this use, because such use lacks approval.
Off-label use of medicine is not illegal, but it “should always be in the setting of informed consent”, the TGA said.
The TGA-approved indications for GnRHa drugs include prostate cancer, where suppression of testosterone might retard tumour growth, and central precocious puberty, when premature sexual development begins in very young children and their sex hormones are suppressed until they are old enough to enter puberty with peers.
Puberty blockers have been promoted as affording a child time to think or to escape the “wrong puberty”. According to international data, almost all children begun on blockers, started as young as ages nine to 11, proceed to cross-sex hormones meant to be taking lifelong.
On December 12 2024, UK Labour Health Secretary Wes Streeting announced the end of this routine use of puberty blockers, saying it was “a scandal that medicine was given to vulnerable young children, without proof that it was safe or effective, or that it had gone through the rigorous safeguards of a clinical trial”.
The following day, Mr. Butler sought urgent advice on puberty blockers, including their safety, the evidence for a pause or ban, and the option of an evidence review or new treatment guidelines.
On January 31 last year, Mr. Butler announced The National Health and Medical Research Council would develop new guidelines and review the existing de facto national guidelines issued in 2018 by the Royal Children’s Hospital Melbourne. Interim advice on puberty blockers is expected mid-year from the NHMRC.
The April 2025 TGA report underscores the gaps in data on usage, safety and efficacy confronting the NHMRC guideline developers, who were to be briefed on the limited nature of TGA oversight.
For serious “adverse events” with puberty blockers, the TGA is relying on notifications; reporting these is mandatory for drug companies, but voluntary for health professionals. Puberty blockers have been talked up by clinicians and activists as a low-risk option with reversible effects should trans-identifying children, re-embrace their birth sex. Among 65 adverse events between 1998 and 2025 with these hormone suppression drugs in patients under 18, none were reported as gender related, although many notifications to the TGA do not specify the indication for which the drugs were prescribed.
The most commonly reported adverse events were injection side reactions, including pain, swelling, infection and access. Most notifications fell between the 2 to 11 age group, consistent with the medicine being given to treat central precautious puberty.
The TGA safety report noted warnings already found in product information for puberty blockers, including convulsions; psychiatric symptoms such as anger, aggression and depression; vaginal bleeding; intracranial hypertension; loss of bone mineral density; hemorrhage of the pituitary gland and risk to future fertility.
Given the lack of adverse events reported tied to gender dysphoria, the 2025 TGA report concluded that a full literature review on the safety of trans puberty suppression was “not warranted at this stage”.
The TGA’s brief literature review failed to include the much discussed paper by British neuropsychologist Sally Baxendale, who found no evidence for the reassuring claim that puberty blockers are “reversible” and warned it was possible these drugs interfere with a critical window in cognitive development for the adolescent brain.
By Bernard Lane
Bernard Lane publishes Gender Clinic News.
Source: The Australian, transcript from the printed edition 23.02.26
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