The Australian Therapeutic Goods Administration (TGA) has updated and aligned safety warnings for people using GLP-1 and dual GIP/GLP-1 receptor agonists. For those not in the know, these are medications like Ozempic, which are used to treat type 2 diabetes and obesity.
It’s used by millions of people around the globe, but the TGA has adjusted the wording on the medication. After it completed an investigation into international and Australian safety data, it found issues with information about potential risks with increased suicidal thoughts.
“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 said on Monday.
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GLP-1 RA medicines and the link to mental health
The GLP-1 RA class of medicines will now have appropriate warnings attached to them to ensure patients have consistent information about the risk of suicidal thoughts or behaviours.
Medicines in that class include the following:
The TGA found there had been 72 reports of suicidal ideation from people using these medications.
The regulator asked for advice from the Advisory Committee on Medicines (ACM) on this issue before updating its protocols.
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While the ACM said there wasn’t sufficient evidence to support an association between GLP-1 RAs and suicidal or self-harming behaviours, it said information about the medicines “were inconsistent and should be harmonised”.
The Committee stressed that updates about the medicine “should not imply a causal association”, but “reflect a class level awareness”.
Product Information (PI) documents about GLP-1 RA medicines will now include the following warning:
“Suicidal behaviour and ideation have been reported with GLP-1 receptor agonists. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behaviours, and/or any unusual changes in mood or behaviour,” the message will say.
“Consider the benefits and risks for individual patients prior to initiating or continuing therapy in patients with suicidal thoughts or behaviours or have a history of suicidal attempts.
Do not use one type of GLP-1 RA during pregnancy
The TGA also discovered a potential risk in taking Mounjaro (tirzepatide) as it could not be ruled out to reduce the effectiveness of oral contraception.
Mounjaro is typically prescribed for people with type 2 diabetes mellitus, chronic weight management, and for the treatment of obstructive sleep apnoea in adults with obesity.
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The updated advice now tells patients to switch to a non-oral contraceptive if they’re using this medication, or add a “barrier method” of contraception for four weeks after initiation and for four weeks after each dose escalation with tirzepatide.
This goes on top of advice to not use GLP-1 RAs during pregnancy.
Mental health support for yourself or a loved one can be found by calling Lifeline on 13 11 14, Mensline on 1300 789 978, or the Kids Helpline on 1800 551 800.Online support is available via Beyond Blue.
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