Statement from the Therapeutic Goods Administration:

The Therapeutic Goods Administration (TGA) monitors the safety of therapeutic products in Australia, including medicines and vaccines, and takes action to address confirmed safety issues. The TGA approves and regulates products based on an assessment of risks against benefits. All medicines, including semaglutide-containing medicines, carry potential risks. Most of these are minor, but sometimes, in rare circumstances, they can be potentially serious. The TGA applies scientific and clinical expertise to its decision-making to ensure that the overall benefits of a product outweigh the risks in the intended population, when used for the approved indications. Further information about how the TGA monitors the safety of therapeutic goods is available on our website at: www.tga.gov.au/safety/safety.

1. To 8 November 2024, the TGA has received a total of 698 adverse event reports in relation to semaglutide-containing medicines. Of those, 578 reports were reports of gastrointestinal disorders, including 12 reports of gastrointestinal obstruction (one in 2022, 3 in 2023 and 8 so far in 2024).

The TGA has been monitoring this safety concern for some time and will continue to do so. The TGA first considered the risk of intestinal obstruction with GLP-1 agonists, including semaglutide, in June 2021. In May this year, we worked with the sponsor of Ozempic and Wegovy, Novo Nordisk Pharmaceuticals, to update the Australian Product Information (PI) for those medicines to include the risk of intestinal obstruction. This was the result of the TGA and other international regulators monitoring and periodically assessing safety data.

2. The TGA reviews all potential associations between therapeutic goods and fatal outcomes reported to us. This review process considers the evidence for a causal link between the product and the diagnosis made by the relevant health professional who examined the patient. Importantly, the TGA does not undertake autopsies, request coronial investigations or make formal determinations of the cause of death, as coroners and treating doctors perform this role.

There have been 21 adverse event reports made to the TGA with a fatal outcome in relation to semaglutide. None of the deaths reported to us have listed gastrointestinal obstruction. While 11 deaths reported to the TGA list gastrointestinal disorders, 7 of these also reported other body system/medical comorbidities relating to the deaths. Please note that reporting of a death or an adverse event to the TGA and publication in our Database of Adverse Event Notifications (DAEN) – medicines does not necessarily mean that a causal link with the medicine has been established. There might be no relationship between the adverse event and the medicine/vaccine – the symptom may be related to another medication taken at the same time, an underlying illness, or other factors. It may be a coincidence that the adverse event occurred when the medicine was taken or administered.

Statement from Novo Nordisk Spokesperson:

At Novo Nordisk, patient safety is a top priority, and we take all reports about adverse events from the use of our medicines very seriously.

We work closely with the TGA and other regulatory bodies around the world to continuously monitor the safety profile of our medicines.

The Australian Product Information for Ozempic® contains information about Gastrointestinal Effects: Ozempic-pi.pdf (novonordisk.com.au).

The Australian Product Information for Wegovy® contains information about Gastrointestinal Effects: Wegovy PI

We stand behind the safety and efficacy of Ozempic®, Wegovy ® and all of our medicines when used consistent with the product labelling and the approved indications.

We don’t disclose prescription numbers for any of our medications due to commercial confidentiality.

Additional information on background:

• Gastrointestinal side effects are well-known side effects of the GLP-1 receptor agonists (GLP-1 RAs) class. The majority are of mild to moderate severity and of short duration.
• GLP-1s have been used to treat type 2 diabetes (T2D) for more than 16 years, and for treatment of obesity for 9 years*