Regulatory Update: MHRA Issues Guidance on GLP-1 Medications Amid Pancreatitis Reports

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance concerning GLP-1 medications, widely used for weight loss and diabetes management. This revision follows an increase in reports of severe acute pancreatitis associated with these injectable drugs.

Understanding the Risk

Between early 2024 and early 2025, approximately 1.6 million adults in England, Wales, and Scotland utilized GLP-1 medications, including semaglutide (Wegovy, Ozempic) and tirzepatide (Mounjaro). Patient information leaflets list pancreatitis as an "uncommon" reaction, affecting about one in 100 patients.

Acute pancreatitis is characterized by sudden inflammation of the pancreas, manifesting with symptoms such as severe abdominal pain, nausea, and fever. This condition often requires hospitalisation for treatment.

Reported Cases and Fatalities

To date, the MHRA's Yellow Card scheme has documented 1,143 reports of acute and chronic pancreatitis among patients using semaglutide or tirzepatide. Tragically, these reports include 17 fatalities.

A significant portion of these reports, 973, were logged in 2025 alone, with 807 specifically concerning tirzepatide and 166 related to semaglutide. Other GLP-1 medications, liraglutide and dulaglutide, also had 146 and 61 reports of pancreatitis, respectively.

MHRA's Stance and Patient Guidance

Dr. Alison Cave, the MHRA's chief safety officer, emphasized the overall safety and efficacy of GLP-1s while highlighting the importance of awareness regarding potential severe side effects.

"While GLP-1s are generally safe and effective, the risk of severe side effects like pancreatitis, though small, necessitates awareness among patients and healthcare professionals."

Patients experiencing severe, persistent stomach pain that radiates to the back, potentially accompanied by nausea and vomiting, are strongly advised to consult a healthcare professional. All such symptoms should also be reported via the Yellow Card scheme.

Future Insights: The Yellow Card Biobank Study

The MHRA is actively engaging GLP-1 patients in the Yellow Card Biobank study, a collaborative effort with Genomics England. This research aims to explore potential genetic influences on the risk of pancreatitis, with the ultimate goal of predicting individual patient risk and enabling safer prescription practices for these medications.

Manufacturer Responses

Novo Nordisk, the manufacturer of Wegovy and Ozempic, reaffirmed its commitment to patient safety. The company recommends that its medications be taken only for approved indications and under the strict supervision of a healthcare professional.

Similarly, Eli Lilly, manufacturer of Mounjaro, stated that patient safety remains its top priority. They noted that their patient information leaflet already acknowledges acute pancreatitis as an uncommon side effect and advises patients to consult their doctors for any side effects experienced.