A safety warning has been issued by Australia's national medicines regulator over a so-called "Hollywood drug" used to treat type 2 diabetes and obesity.
The Therapeutic Goods Association has updated its product information for the relatively new class of medicines known as GLP-1 receptor agonists, warning of an increased risk of potential suicidal ideation.
In a statement to 1News, New Zealand's Ministry of Health said it was aware of the Australian development and was seeking further information from companies marketing GLP-1 inhibitors here.
World Health Organisation wants more equitable provision of the medicines that are changing people’s lives. (Source: 1News)
The class includes semaglutide, the drug marketed in Australia as Ozempic.
The drug is taken as a weekly injection to treat diabetes, but is also widely used for weight loss, making it popular among celebrities.
Other GLP-1 receptor agonists included in the warning were semaglutide sold as Wegovy; liraglutide sold as Saxenda; dulaglutide (Trulicity) and tirzepatide (Mounjaro).
The TGA said patients taking any of these medicines should tell their health professional if they experienced new or worsening depression, suicidal thoughts or any unusual changes in mood or behaviour.
The updates have been issued after investigations by the TGA and other international regulators.
The product warning for tirzepatide (Mounjaro) was also updated to reflect a risk of decreased effectiveness of oral contraception when first taking or increasing the dose of the drug.
The TGA advised patients taking tirzepatide 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.
It added that no GLP-1 receptor agonists should be used during pregnancy and that individuals with child-bearing potential should use effective contraception when using the drugs.
Medsafe in NZ seeks updates from companies marketing GLP-1 inhibitors
In New Zealand, a Ministry of Health spokesperson said Medsafe was aware of the Australian medicines regulator's advisory about a possible link between GLP-1 RA class medicines and suicidal thoughts or behaviour.
"Medicines approved in New Zealand which belong to this group include Saxenda, Wegovy, Ozempic, Trulicity and Victoza which are used to treat type 2 diabetes and/or obesity. Mounjaro also belongs to this group of medicines but is not approved in New Zealand.
"Medsafe has investigated the potential risk of suicidal thoughts or behaviour associated with GLP-1 inhibitors several times, most recently last year.
"The investigation concluded there was not enough evidence to support a causal relationship. This is in line with conclusions from international regulatory agencies such as EMA (European Medicines Agency), FDA (US) and MHRA (UK) and TGA (Australia)."
The spokesperson said information about suicidal behaviour and ideation was currently included in some New Zealand data sheets.
"However, as a precaution and because the New Zealand data sheets and Consumer Medicines Information (CMI) across the class are inconsistent with information on psychiatric disorders, Medsafe has requested updates from the companies marketing the GLP-1 inhibitors to align the information.
"Like the TGA, our advice to patients is to tell their healthcare provider if they experience new or worsening depression, suicidal thoughts, or any changes in mood or behaviour."
The spokesperson added that Medsafe would continue to monitor this issue.
– additional reporting by 1News.
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