MHRA Strengthens Pancreatitis Warnings for GLP-1 Agonists

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a strengthened drug safety update on the risk of acute pancreatitis associated with GLP-1 receptor agonists and dual GIP/GLP-1 receptor agonists. The update follows post-marketing reports of necrotising pancreatitis and fatal outcomes in patients treated with these medicines.

The safety update applies to all GLP-1 receptor agonist products licensed in the UK, including:

  • Semaglutide (Ozempic, Wegovy, Rybelsus)
  • Tirzepatide (Mounjaro)
  • Liraglutide (Saxenda, Victoza)
  • Exenatide (Byetta, Bydureon)
  • Lixisenatide (Lyxumia)
  • Dulaglutide (Trulicity)

What the Update Says

The MHRA's strengthened warning emphasises that acute pancreatitis has been reported in patients receiving GLP-1 receptor agonist therapy, with some cases presenting as necrotising pancreatitis and a small number resulting in death. The regulator advises healthcare professionals to:

  1. Be vigilant for signs and symptoms of acute pancreatitis, including persistent severe abdominal pain that may radiate to the back.
  2. Discontinue GLP-1 receptor agonist treatment immediately if pancreatitis is suspected.
  3. Not reinitiate treatment in patients who have confirmed a diagnosis of pancreatitis.
  4. Report suspected adverse reactions via the Yellow Card scheme.

Patients are advised to seek immediate medical attention if they experience persistent severe abdominal pain.

Context and Background

Acute pancreatitis is a known but rare adverse event associated with GLP-1 receptor agonist therapy. It was identified during clinical trials and has been included in product information for several years. However, post-marketing surveillance has now revealed cases of greater severity, including necrotising forms and fatal outcomes, prompting the MHRA to strengthen the existing warnings.

This is the third significant GLP-1 safety signal the MHRA has addressed in 2025, following earlier warnings on pulmonary aspiration risk before anaesthesia and a very rare risk of non-arteritic anterior ischaemic optic neuropathy (NAION) with semaglutide.

Implications for Peptide Researchers

For researchers working with GLP-1 receptor agonists and dual GIP/GLP-1 agonists, this safety update reinforces the importance of:

  • Monitoring pancreatic enzymes and relevant biomarkers in research protocols involving GLP-1 agonists.
  • Documenting any gastrointestinal adverse events thoroughly, particularly abdominal pain.
  • Being aware that pancreatitis risk, while rare, can be severe and potentially fatal.
  • Noting that the MHRA continues to monitor GLP-1 safety as usage expands rapidly across the UK population.

The broader regulatory landscape for GLP-1 peptides continues to evolve as these medicines see widespread adoption for both diabetes and weight management. The MHRA has reiterated that GLP-1 receptor agonists are prescription-only medicines (POMs) and must not be supplied through improper channels.

Related Reading

This article is for research and educational purposes only and does not constitute medical advice. GLP-1 receptor agonists are prescription-only medicines in the UK.

This article is AI-researched and editorially reviewed. It is provided for research and educational purposes only and is not medical advice. Research peptides are not licensed for human consumption in the UK.