Weight loss drugs linked to 62 reported deaths and more than 2800 adverse reactions in Australia
The TGA's database records suspicion, not cause, and the regulator has added three separate class-wide warnings to the drugs since December.
Australia’s medicines regulator has received reports of 62 deaths and more than 2800 adverse reactions suspected of being linked to weight loss and diabetes drugs including Ozempic, Wegovy and Mounjaro.
The figures come from the Therapeutic Goods Administration’s Database of Adverse Event Notifications, a voluntary register where doctors, patients and pharmaceutical companies log events they suspect a medicine may have caused.
A report is a suspicion. It is not a finding.
Leading cardiologist Dr Ross Walker said "an association does not necessarily mean the drug caused the death".
He said the bigger threat was "diabesity" — the combination of diabetes and obesity — and that for some patients the risk of remaining overweight outweighed the risk of the medication.
About 500,000 Australians are using the drugs, according to the Daily Telegraph, which first reported the figures.
The reported reactions run from nausea and vomiting through to pancreatitis.
What sits behind them is a regulator that has added three separate class-wide warnings to these medicines in the past eight months.
In December it aligned the product information for every GLP-1 medicine sold here — Ozempic, Wegovy, Saxenda, Trulicity and Mounjaro — to carry a precaution about suicidal thoughts and behaviours.
Its own advisory committee found the evidence was not strong enough to confirm a link.
The same review could not rule out that oral contraception becomes less effective when a patient starts Mounjaro or increases the dose.
In July the TGA went further, updating warnings across the class over a rare eye condition called non-arteritic anterior ischaemic optic neuropathy, or NAION.
It causes sudden loss of vision, usually in one eye, and it can be permanent. No treatment has been shown to restore sight once it occurs.
The regulator has also warned of the risk of aspiration under general anaesthetic and deep sedation, because the drugs slow the passage of food through the stomach.
None of that establishes that these medicines killed anyone.
Britain’s regulator, which runs a comparable voluntary scheme across a far larger patient base, has recorded 216 death reports and about 158,000 adverse reaction reports against the same class of drug.
It says a report does not mean the medicine caused the event.
The TGA’s advice is unchanged: no treatment is risk-free, and nobody should stop a prescribed medicine without speaking to their doctor.
Sixty-two reports against half a million users is not an epidemic. It is a reminder that the warning label on these drugs is still being written.