TGA safety warning on weight-loss drugs
This week the Therapeutics Goods Administration updated safety information about GLP-1 RA class medicines (including Ozempic, Wegovy and Mounjaro) and mental health and the information on tirzepatide and oral contraceptives.
The TGA sought advice from the Advisory Committee on Medicines (ACM) who found that the evidence available was not sufficient to support an association between GLP-1 RAs and suicidal or self-harming behaviours. However, the ACM noted that the Product Information (PI) and Consumer Medicines Information (CMI) documents across the class were inconsistent and should be harmonised.
In its statement TGA said doctors should monitor patients for the emergence of worsening depression, suicidal thoughts or behaviours, and/or unusual changes in mood or behaviour.
Federal AMA President Dr Danielle McMullen told Nine’s Today show there had not been an upsurge in risk or new evidence come to light.
“The evidence around this is really mixed with some studies showing an increased risk of suicidal thoughts in a small group of patients, including those on other medicines like anti-depressants. But it is not really strong evidence.”
The TGA also looked into the potential for reduced effectiveness of oral contraception when first taking or increasing the dose of Mounjaro (tirzepatide) and found that this association could not be ruled out.
As a precautionary measure, the product warnings for tirzepatide have been updated to include further advice for patients using oral contraceptives.
TGA product safety statement on tirzepatide
TGA product safety statement on GLP-1 Ras and suicidal or self-harming behaviours
Watch federal AMA President Dr Danielle McMullen on the Today show
