Australia’s medicine regulator issued a safety alert for Ozempic and similar drugs on Monday over a potential risk of suicidal thoughts and behaviours.
The Therapeutic Goods Administration (TGA) cited concerns
people taking Ozempic, Wegovy, Saxenda, Trulicity, and Mounjaro risk depression, suicidal thoughts and “unusual changes in mood”.
The regulator also said it “couldn’t rule out” the possibility that Mounjaro could make the contraceptive pill less effective in some cases.
Background
Ozempic is the brand name of an injectable medication, originally developed to treat diabetes. It’s ‘semaglutide’, belonging to a family of drugs called GLP-1s.
Other GLP-1s also include Wegovy, Saxenda, Trulicity, and Mounjaro, though not all are semaglutides.
Dr Michael Bonning from the Australian Medical Association told TDA earlier this year that GLP-1s “slow gastric emptying, so you feel fuller, faster... You ended up with people losing significant amounts of weight.“
Side effects
Bonning told TDA the side effect of weight loss means “these drugs have become increasingly popular for an indication that they weren’t originally put on the market for.”
Other common side effects associated with GLP-1s include nausea, vomiting and diarrhoea — but many users reported more serious side effects in a callout to TDA’s Instagram earlier this year.
Examples include gastrointestinal issues, emergency gallbladder removal surgeries, and severe mental health side effects.
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Announcements
On Monday, the TGA said patients taking these medications “should tell their health professional if they experience new or worsening depression, suicidal thoughts or any unusual changes in mood or behaviour.”
Labels on GLP-1s will now note the risk of suicidal thoughts or behaviours.
The TGA already tracks reports of negative side effects associated with the use of these drugs. This year, suicidal ideation made up 3% of all reports to the TGA database related to weight-loss medications.
In the two years to January 2025, there were three reports of attempted suicide, and separately, two deaths by suicide associated with the use of GLP-1s.
Ozempic was the only product “suspected to be related” to both deaths.
There were also four Ozempic-related poisoning deaths due to misuse, overdose or accident during this period.
However, this does not mean the TGA has determined these deaths are related to GLP-1s.
The TGA also said it couldn’t rule out whether Mounjaro reduced the strength of oral contraception when first taken or a dosage is increased.
The TGA advises patients to use non-oral contraception for four weeks when starting Mounjaro and four weeks after increasing their dosage.
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