Urgent health warning is issued over a very disturbing side-effect linked to trendy new weight loss drugs like Ozempic and Mounjaro
The rise of GLP-1 receptor agonists, including Ozempic and Mounjaro, being used for weight loss has been linked to a higher risk of self-harming thoughts and behaviour.
The Therapeutic Goods Administration, Australia’s medicine regulator, issued a safety warning regarding drugs that activate GLP-1, the hormone which regulates blood sugar and appetite, on Monday.
The class of drugs is largely intended to treat type two diabetes, but have become popular for their weight loss side effects.
On Monday, the TGA announced a search of its Database of Adverse Event Notifications on September 23 retrieved 85 reports of GLP-1 RAs linked to a decline in mental health.
Those included 72 for suicidal ideation, six for depressional suicide, four for suicide attempt, two for suicide and one of self-injurious ideation.
The class of drugs include Ozempic (semaglutide), Wegovy (semaglutide), Saxenda (liraglutide), Trulicity (dulaglutide), and Mounjaro (tirzepatide).
The disturbing data triggered an investigation by an independent expert group, the Advisory Committee on Medicines.
The committee had previously in June reported there was not enough evidence to link GLP-1 medications to suicidal ideation or behaviours.
The Therapeutic Goods Administration has linked GLP-1 receptor agonists, including Ozempic and Mounjaro, to a higher risk of suicidal ideation (pictured, Australia actress Rebel Wilson who briefly used Ozempic for weight loss)
The TGA found it had 85 reports linking GLP-1 RAs to suicidal thoughts and behaviours in September
However, the investigation requested by the TGA found there was a ‘complex interplay between mental illness and chronic endocrine disorders’, which GLP-1 RAs can be used to treat.
It also noted a ‘potential relationship between weight loss and suicidal or self-harm ideation’.
‘Patients taking these medicines should tell their health professional if they experience new or worsening depression, suicidal thoughts or any unusual changes in mood or behaviour,’ the TGA’s alert read.
The Advisory Committee on Medicines also advised the information regarding GLP-1 RAs should be ‘harmonised’ as existing warnings are inconsistent.
The TGA has since updated its advice for the class of medicines to include a warning about suicidal ideation.
It has also updated the warning for Mounjaro (tirzepatide) following anecdotal reports of woman falling pregnant while on the drug.
An investigation by the TGA found a link between tirzepatide and the decreased effectiveness of oral contraception ‘could not be ruled out’.
One study in 2024 found tirzepatide doubled the amount of time it took for ethinylestradiol (synthetic oestrogen used in the combined oral contraceptive pill) to be fully absorbed in the bloodstream.
GLP-1 RAs were largely created to treat type two diabetes but have become popular for its weight loss side effects (pictured, Roxy Jacenko who previously shared her experience using Ozempic)
GLP-1 RAs warnings were updated from Monday to include advice about its link to suicidal ideation
The delay could be caused by tirzepatide’s effect on slowing digestion, as ethinylestradiol is mostly absorbed in the small intestine.
However, five other studies found patients taking oral contraceptives and tirzepatide saw no change in the amount of ethinylestradiol in their bloodstream.
The TGA will now advise Mounjaro patients to use non-oral contraception for the first four weeks of using the drug and four weeks after any dose increase.
‘None of the GLP-1 RAs should be used during pregnancy, and individuals of childbearing potential are advised to use effective contraception during treatment with a GLP-1 RA,’ it said.
Daily Mail has contacted the owners of Ozempic and Mounjaro for comment.
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