UK regulators have strengthened safety warnings for glucagon-like peptide-1 (GLP-1) receptor agonists and dual GLP-1/GIP receptor agonists following reports of rare but serious cases of acute pancreatitis, including necrotising and fatal outcomes.
In a January 2026 Drug Safety Update, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) confirmed that product information for all medicines in this class has been updated to more clearly highlight the risk of acute pancreatitis. The revised labelling reinforces the need for clinicians to remain alert to symptoms such as severe and persistent abdominal pain, particularly pain radiating to the back, which may be accompanied by nausea and vomiting.
The MHRA advises that treatment should be discontinued immediately if pancreatitis is suspected and should not be restarted if the diagnosis is confirmed. Patients are also encouraged to seek urgent medical attention if symptoms occur and to report adverse events through the Yellow Card Scheme.
According to the regulator, post-marketing surveillance data submitted to the MHRA include reports of pancreatitis across multiple GLP-1 and dual GLP-1/GIP agents, with a small number of cases described as necrotising or fatal. While the MHRA emphasised that these events remain rare and that the overall benefit-risk profile of these medicines remains favourable for most patients, the strengthened warnings were introduced to ensure clinicians and patients are aware of the potential severity of the condition.
The update applies to widely prescribed medicines including semaglutide, liraglutide, dulaglutide and tirzepatide, which are approved in the UK for type 2 diabetes and, in some cases, weight management.
Australia’s current position
Pancreatitis is already listed as a potential adverse effect in Australian product information for these medicines, consistent with long-standing international labelling. However, as of early 2026, the TGA has not issued a dedicated safety alert or class-wide update focused on rare severe pancreatitis outcomes comparable to the MHRA’s recent action.
Instead, the TGA’s most recent regulatory updates for this medicine class have addressed other safety considerations. In late 2025, the regulator aligned product information across all GLP-1 receptor agonists to include strengthened warnings about reports of suicidal thoughts and behaviours, advising healthcare professionals to monitor patients for changes in mood. Additional updates have also highlighted the risk of delayed gastric emptying and the potential for pulmonary aspiration during general anaesthesia or deep sedation.
The TGA has previously stated that it continues to monitor international safety signals and post-marketing data and will update Australian product information where necessary to reflect emerging evidence.
