MHRA re-issues GLP-1 product information to strengthen pancreatitis warning
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The Medicines and Healthcare products Regulatory Agency (MHRA) has updated product information for GLP-1 receptor agonists to highlight the “small risk” of severe acute pancreatitis when using these medicines.
The medicines watchdog said acute pancreatitis is a “known but infrequent” side effects that can in “extremely rare cases” progress to severe complications including necrotising and fatal pancreatitis.
Pancreatitis can be “challenging to recognise” in its early stages, the MHRA warned, as initial symptoms like abdominal pain and nausea can resemble more common gastrointestinal side effects of the drugs.
The updated information applies to all GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists, namely dulaglutide, exenatide, liraglutide, semaglutide and tirzepatide.
The MHRA said that between 2007 and October 2025 it received 1,296 Yellow Card reports of pancreatitis associated with these medicines, including 19 that involved a patient fatality and 24 reports of necrotising pancreatitis.
“Clinicians and patients are reminded to be alert to initial symptoms such as severe, persistent stomach pain that may radiate to the back and may be accompanied by nausea and vomiting,” said the MHRA, adding that patients who experience this should be advised to seek urgent medical attention.
An estimated 1.6 million adults in Great Britain used GLP-1s for weight loss between early 2024 and early 2025, a University College London study has found, with the MHRA estimating that 25.4 million packs of GLP-1s have been dispensed in the last five years.
MHRA chief safety officer Alison Cave said: “Patient safety is the MHRA’s top priority and we continually monitor the safety and efficacy of all licensed medicines.
“For the vast majority of patients who are prescribed GLP-1s, they are safe and effective medicines which deliver significant health benefits.
“The risk of developing these severe side effects is very small, but it is important that patients and healthcare professionals are aware and alert to the associated symptoms.”