Dec 02, 2025
3 min read
High-profile weight loss and diabetes drugs come with two new warnings.
Watch for published safety opinions for ozempic and glp-1
by Kate Aubusson
The Australian Pharmacopoeia has issued a safety warning about the risks of adverse reactions and behavior associated with GRP-1 receptor antagonists including Ozempic.
The Medicines Agency also warns that a connection between the GLP-1 receptor agonist drug Monjaro (terzapatide) and the reduced effectiveness of oral contraceptives cannot be ruled out during the global increase in the so-called "Osympic babies".
The TGA's safety alert issued on Monday said it had updated product warnings for a high class of drugs designed to treat type 2 diabetes and obesity (but known to be used for weight loss more widely) following investigations by international regulators.
The drugs involved are:
- Ozempic (semaglutide)
- Wegovy (semaglutide)
- Saxenda (liraglutide)
- Trulicidade (dulaglutide)
- Mounjaro (tirzepatid)
"Patients taking these drugs should tell their health care providers if they experience depression, unusual thoughts or unusual changes in their mood or behavior," it says.
TGA access to its database of virus event notifications on September 23, including 72 active, four active, two voluntary.
His investigation included seeking advice from an independent specialist group, the Medicines Access Committee, which reported in June that there is insufficient evidence of a causal link between the medicines and suicidal ideation or behaviour.
But the advisory board found "a complex between mental illness and chronic endocrine disorders" (which can be treated with GLP-1 RAS) and "a potential trade-off between weight loss and destructive ideation or destruction."
It noted that product information for this class of drugs should be consistent and "consistent".It recommended updating the safety advisory after validating community concerns and considering the pros and cons of doing so, including the potential risks of causing unwarranted alarm where evidence is lacking.
Mounjaro's product warning will also be updated after a TGA study found that the drug's potential to reduce the effectiveness of oral contraception "cannot be ruled out".
The 2024 review included another study that found tirzepatide reduced the amount of ethinylestradiol (estrogen produced in the combined pill) by 20 percent. The other five studies did not show any problems or significant fluctuations.
Another study found that tirzepatide increased the time that ethinyl estradiol is completely absorbed into the blood from two to four hours, which may be due to the effect of the drug to slow gastric emptying because ethinyl estradiol is mainly absorbed in the small intestine.
Patients will now be advised to switch to non-oral contraception or to use a barrier method of contraception (such as condoms) for four weeks after first taking the drug and for four weeks.
"Any GLP-1 RAS should not be used during pregnancy and women of childbearing potential should use effective contraception during treatment with GLP-1 RAS.
The UK drug regulator advised all pregnant women in August not to be pregnant when they receive safety information to find out if it could harm the unborn child.The regulator received more than 40 reports of unintended pregnancies by women using the drugs.
Novo Nordisk, owner of Ozempic, said semaglutide is the subject of robust studies in clinical development programs.
"Given the evidence of the expiration of clinical trials, collection reports and primary studies," the company's confusion and medical control said.
"We remain committed to patient safety and transparency by maintaining updated safety information and working closely with health authorities and regulatory bodies around the world."
Eli Lilly, the maker of Mounjaro, has been contacted for comment.
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