TGA safety information on compounded versions of Ozempic 5 April 2024 The impact of the ongoing Ozempic shortage, which has been experienced since early 2022, continues to cause significant concerns for Australians living with type 2 diabetes. Diabetes Australia shares and has expressed these concerns to the Therapeutic Goods Administration (TGA) and we will continue to advocate for prioritised access to these diabetes medicines for people living with diabetes. In recent correspondence, Diabetes Australia has encouraged the TGA to thoroughly investigate the shortages of a number of diabetes-related medicines and products in recent years, and redouble efforts to ensure Australians can be confident that supply chains are sufficient to meet their needs. In this context of the ongoing shortage, Diabetes Australia acknowledges the impact that recent media coverage may have had on people living with diabetes regarding the TGA cracking down on compounded semaglutide-like products – semaglutide being the active ingredient in medicines such as Ozempic. Nonetheless, this media coverage serves as a good reminder of the safety risks associated with unapproved products. In response to public health and safety concerns, the TGA announced in February a targeted consultation process aimed at preventing the compounding of medicines containing semaglutide by compounding pharmacists. In recent weeks there has been prominent media coverage of search warrants executed on pharmacies regarding the unlawful manufacture, supply and export of such products. The only TGA approved products containing semaglutide are identified under the trade names Ozempic and Wegovy. Diabetes Australia supports the TGA’s decision to stop the compounding of medicines containing semaglutide. These products are ‘unapproved’ therapeutic goods and have not been evaluated by the TGA for safety, quality and efficacy. When a medicine is compounded, it can have a different strength and different ingredients from similar medicines approved by the TGA. More information about the safety of semaglutide-like products can be found on the TGA website.
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