LAUSR

Semaglutide (Ozempic) is a glucagon-like peptide 1 (GLP1) analogue approved in Australia for type 2 diabetes in 2019. A randomised controlled trial of obese individuals found a 15% reduction in body weight with semaglutide (2.4 mg/week). This led to considerable attention in the mainstream, medical and social media to be a weight-loss agent, highlighted by that paper’s Altmetric rank of 1474 out of 22 million outputs scored. Semaglutide was approved for weight loss by the US Food and Drug Administration (FDA) in June 2021. In Australia, use for weight loss was off-label until September 2022, when Wegovy was approved; however, the sponsor has not confirmed a launch date for Wegovy in Australia. Local media stories and social media coverage caused a surge in demand for Ozempic and a resulting shortage. The Therapeutic Goods Administration (TGA), medical bodies, pharmacy groups and the sponsor released a joint statement in May 2022 to preserve supply for people with diabetes. We conducted a study using data from the New South Wales Poisons Information Centre (NSWPIC), Australia’s largest PIC, taking 50% of national poisoning calls. We extracted data on exposures to semaglutide, from September 2019 to August 2022 and analysed monthly trends. This was approved by the Sydney Children’s Hospitals Network Human Research Ethics Committee. We compared poisoning exposures with Pharmaceutical Benefits Scheme (PBS) dispensings (publicly available: https://www.pbs.gov.au/info/browse/statistics). Semaglutide is PBS Streamlined Authority for diabetes not responding to other treatments. There were 137 exposures, all through injection. The majority (74%, n = 101) were therapeutic errors (e.g. incorrect dose/interval), followed by adverse reactions (15%, n = 21), intentional exposures (self-harm and deliberate misuse, 8%, n = 11) and other exposure types (3%, n = 4). Most were women (86%, n = 118), and the majority (95%, n = 130) were adults aged 20–74 years. Hospital assessment was deemed necessary in 23% (n = 32 in hospital or referred to hospital by PIC) and GP assessment in 20% (n = 27). Referrals were typically made as a result of the presence of significant gastrointestinal symptoms. At least four patients intentionally used semaglutide not prescribed for them, all for weight loss. Therapeutic errors most frequently occurred on initiation and dose escalation, with 53 (53% of 101 therapeutic errors) patients commencing semaglutide within the month prior to the call and 43 within the first week/first dose. Where specified (n = 87), patients were using semaglutide for weight loss in 64% (n = 56). Errors included supratherapeutic doses and increased administration frequency (e.g. daily vs weekly). Time trends (Fig. 1) show a sharp increase in exposure in the latter half of 2021, following the FDA weight loss listing and associated media attention. The increase in exposures closely tracked an increase in dispensing. Monthly exposures peaked in February 2022 and declined following shortages and the TGA alert. In conclusion, we found increasing poison centre calls regarding semaglutide, associated with increased use and publicity as being a weight loss agent. Supply constraints and TGA guidance were followed by a reduction in reports. With the approval of Wegovy and forecast restoration of supply, exposures are likely to increase again. The high number of dosing errors on treatment initiation