Australia’s drug regulator has issued new safety alerts for widely used diabetes and weight-loss drugs, including Ozempic, Wegovy, Saxenda, Trulicity and Mounjaro. The Therapeutic Goods Administration (TGA) announced that all GLP-1 receptor agonists will now carry new warnings about possible mental health risks and, in one case, contraception concerns.
The change comes after reports of suicidal thoughts, depression and unusual mood shifts in some patients using these medications, The Guardian reported. The TGA says there is no proven causal link, but the number of reports is significant enough to require “a precautionary approach.”
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Mental health concerns under review
A recent 2024study using the World Health Organization’s global database of drug reactions found that suicidal thoughts were slightly higher than expected among people using semaglutide, the active ingredient in Ozempic and Wegovy.
Following these findings, the TGA sought advice from its Advisory Committee on Medicines. The committee concluded that there is not enough evidence to show the drugs directly cause these symptoms, but noted the complex interplay between mental illness and chronic endocrine disorders, as per The Guardian.
TGAdata up to September recorded 72 reports of suicidal ideation, six reports linked to suicide, four suicide attempts, two completed suicides and a case of self-injury ideation.
With over two million semaglutide prescriptions issued in 2023–24 under the Pharmaceutical Benefits Scheme, experts say monitoring is essential, The Guardian noted.
Dr Terri-Lynne South, chair of the RACGP’s obesity management group, told the outlet, “We do think there might be a subgroup of patients who may be more vulnerable to a worsening of their mental health.”
She noted that this seems especially true for people with a past or current history of depression or anxiety, or those on antidepressant medication.
South added that rapid weight loss itself can sometimes be mentally challenging, becoming “a triggering event from a mental health point of view.”
Mounjaro linked to contraception concerns
In a separate update, the TGA has warned that Mounjaro may reduce the effectiveness of oral contraceptives when patients start the medicine or increase their dose. As the drug slows gastric emptying, it may impact how well the pill is absorbed.
As a precaution, the regulator advises users to switch to a non-oral contraceptive or add a barrier method for four weeks after beginning Mounjaro or raising the dose. The TGA also reminded that none of the GLP-1 drugs should be used during pregnancy.
South said Mounjaro’s effect on digestion has been noted since it arrived in Australia. “The drug delays food and everything else moving through the digestive system, which can impact the absorption of the oral contraceptive pill,” she explained to The Guardian.
The TGA emphasised that these updates are part of standard post-market surveillance, as rare side effects often only appear after medicines are used by large numbers of people.
