Watchdog updates warnings for Ozempic-style drugs over potential risk of suicidal thoughts
The TGA has issued a new safety warning for GLP-1-based drugs including Ozempic. (ABC News: Phil Hemingway)
In short:
The Therapeutic Goods Administration has released a new safety alert for glucagon-like peptide-1 medications.
GLP-1-based medications include the likes of Ozempic, Wegovy and Mounjaro, which have increasingly been used to manage type 2 diabetes and obesity.
The TGA says patients taking the affected medicines should tell their doctor if they experience changes in mood or behaviour.
Australia's medicines regulator has issued a safety warning over the potential risk of suicidal thoughts and behaviours when taking Ozempic-style drugs.
The Therapeutic Goods Administration (TGA) released a safety alert on Monday, saying it had updated product warnings for GLP-1-based drugs to "ensure consistent information regarding the potential risk of suicidal thoughts or behaviours".
"The updates follow investigations by TGA and other international regulators," the alert said.
"Patients taking any of 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 stressed there was not enough evidence to conclude the drugs caused those changes.
But it said there was a complex relationship between mental illness and the conditions GLP-1 drugs treat, and also a possibility that weight loss itself could be associated with suicidal thoughts.
The affected drugs currently marked in Australia are:
- Ozempic (semaglutide)
- Wegovy (semaglutide)
- Saxenda (liraglutide)
- Trulicity (dulaglutide)
- Mounjaro (tirzepatide)
Separately, the TGA warned a link between the use of GLP-1-type drug tirzepatide, known by the brand name Mounjaro, and reduced effectiveness of oral contraception could not be ruled out.
It said product warnings for tirzepatide had been updated as a precautionary measure to include further advice for patients using oral contraceptives.
"Our investigation into the potential for reduced effectiveness of oral contraception when first taking or increasing the dose of Mounjaro (tirzepatide) has found that this association could not be ruled out.
"Patients taking tirzepatide are advised to switch to a non-oral contraceptive or add a barrier method of contraception for four weeks after first taking the medicine and for four weeks after each increase in the dose."
The safety alert also noted no GLP-1-type medication should be used during pregnancy.
GLP-1-based drugs are a breakthrough class of medication that mimic the activity of a natural hormone, slowing digestion and helping people feel full for longer.
They were originally developed to treat people with type 2 diabetes, but have gained prominence helping people manage obesity.
Some international research has raised concerns about a high risk of depression, anxiety and suicidal ideation among people with anxiety or depression who take GLP-1-type medication.
The US Food and Drug Administration (FDA) has been evaluating reports of suicidal thoughts or actions in people on GLP-1-type medications, with preliminary evaluation saying it had "not found evidence that use of these medicines causes suicidal thoughts or actions".
"However, because of the small number of suicidal thoughts or actions observed in both people using GLP-1 RAs and in the comparative control groups, we cannot definitively rule out that a small risk may exist; therefore, FDA is continuing to look into this issue," a communication stated last year.
The TGA issued a safety warning over the potential risk of suicidal thoughts and behaviours when taking Ozempic-style drugs. (Reuters: George Frey)
Several international studies have examined the potential link between GLP-1 medications and psychiatric conditions, with the results varying. Some found no association.
But one study published in Scientific Reports last year found the drugs were associated with significantly higher risks of depression, anxiety and suicidality.
The researchers speculated that could be because the drugs altered the balance of dopamine in the brain.
The TGA said it had received 72 reports of suicidal ideation, as well as about a dozen reports of suicide, suicide attempts and depressional suicide combined.
Reports have suggested as many as half a million Australians take the drugs.
The TGA said it conducted a "comprehensive investigation" and had sought advice from the Advisory Committee on Medicines (ACM), which found the evidence available was not sufficient to support an association between GLP-1-type drugs and suicidal or self-harming behaviours.
However, it noted product and consumer medicines information was inconsistent and should be harmonised.
"The ACM stressed that updates should not imply a causal association, but reflect a class level awareness," the safety alert said.