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UK Regulator Adds Severe Pancreatitis Warning to Ozempic, Wegovy and Mounjaro

The regulator added the warning after new safety reports of acute pancreatic inflammation.

Overview

  • The MHRA updated product information for GLP-1 drugs to note a small risk of severe acute pancreatitis and urged patients to seek urgent care for persistent abdominal pain and report cases via the Yellow Card scheme.
  • The agency has logged more than 1,000 Yellow Card reports of pancreatitis linked to these medicines with rare serious or fatal outcomes, with most reports recorded in 2025.
  • Use of GLP-1 therapies has expanded rapidly, with UCL estimating 1.6 million users across Great Britain in early 2024–25 and industry putting current use nearer two million.
  • The MHRA is enrolling GLP-1 patients into the Yellow Card Biobank with Genomics England to investigate genetic factors that may raise susceptibility to pancreatic inflammation.
  • Clinicians report more gallstones and gallbladder removals among GLP-1 users, with 80,196 cholecystectomies in England in 2024–25 (up 15%), and they are calling for research to separate drug effects from rapid weight loss.