On 26 July 2024, the US FDA issued an alert to healthcare providers in relation to dosing errors associated with compounded injectable semaglutide, including imitations of Novo Nordisk’s Ozempic® and Wegovy®. The FDA has received reports of adverse events, including hospitalisations, linked to overdoses of compounded semaglutide injectable products, often due to dosing errors by patients and healthcare providers. Patients unfamiliar with self-injections and the use of different measurement units (millilitres, milligrams, units) have contributed to these errors. The FDA’s notice urges healthcare providers and compounders to ensure patients have the correct syringe size and understand how to measure doses accurately. Compounded drugs in the US carry higher risks since they do not undergo FDA premarket reviews and are only to be used when no FDA-approved options meet patient needs.
The FDA’s guidance aligns with the announcement by the Australian government on 22 May 2024 regarding compounded glucagon-like peptide-1 receptor agonists (GLP-1RAs). Unlike medications approved by the Australian Therapeutic Goods Administration (TGA), compounded GLP-1RAs are not subjected to the same rigorous safety, quality, and efficacy evaluations. Amid rising concerns and adverse events, including hospitalisations, the Australian government will remove GLP-1RAs, such as those imitating Novo Nordisk’s Ozempic® (semaglutide) and Eli Lily’s Mounjaro® (tirzepatide), from the pharmacy compounding exemption effective 1 October 2024. This aims to ensure patient safety by promoting the use of regulated alternatives and follows advice from the TGA issued in June 2024.