Alerts

TGA is issuing a safety advisory about the importation of unregistered GLP-1 products that are being promoted online for weight-loss.

Consumers and health professionals should be aware that examples of counterfeit products have been stopped at the Australian border. These tablets may pose a serious risk to your health and should not be used.

Consumers and health professionals should be aware that examples of substandard Fitaro semaglutide pre-filled syringes have been stopped at the Australian border.

We have approved overseas-registered substitutes for Pegasys 135 micrograms/0.5 mL and 180 micrograms/0.5 mL pre-filled syringes.

Further examples of counterfeit Ozempic-labelled products have been detected and stopped at the Australian border.

More prominent warnings are being added to the Product Information and Consumer Medicine Information for all oral and injectable (systemic) fluoroquinolones to strengthen existing warnings about serious side effects.

Extra safety information is being added to all montelukast products to highlight the existing warnings about serious behaviour and mood-related changes

There have been reports of the dose counter stopping after the 10th dose and not locking after the 60th dose. If this happens, you should return the product to your place of purchase or contact Boehringer Ingelheim.

There are new warnings about the risks of heart attack and stroke with taking romosozumab (Evenity). The Product Information (PI) and Consumer Medicine Information (CMI) have been updated to reflect these risks.

Our safety advisory includes information for consumers and health professionals about low levels of nitrosamine impurity in medicines containing sitagliptin.

TGA investigation - potential low levels of contamination with N-nitrosovarenicline

Update 2 - contamination with N-nitrosodimethylamine