The UK’s medicines regulator has issued a warning about a small, but notable, increased risk of severe acute pancreatitis among users of popular weight-loss and diabetes drugs. This comes after a significant surge in reported cases through the country’s Yellow Card adverse reaction monitoring scheme.
Rising Reports, Serious Complications
Between early 2024 and early 2025, roughly 1.6 million people in the UK used GLP-1 medications like semaglutide (Wegovy, Ozempic) and tirzepatide (Mounjaro). These drugs have gained prominence for weight management, but now carry a heightened awareness of potential risks. Acute pancreatitis, an inflammation of the pancreas, manifests with severe abdominal pain, nausea, and fever—often requiring hospitalization.
The Medicines and Healthcare products Regulatory Agency (MHRA) has logged 1,143 reports of acute and chronic pancreatitis linked to semaglutide or tirzepatide, including 17 fatalities. The vast majority of these cases (807) involved tirzepatide, with 166 linked to semaglutide. The increase in reports is why the regulator felt it necessary to update its guidance.
Why This Matters
Pancreatitis is rare, affecting about one in 100 patients taking these medications, according to product leaflets. However, the recent spike in cases, especially with tirzepatide, signals a trend that demands attention. The pancreas is critical for digestion and blood sugar regulation; severe inflammation can lead to life-threatening complications.
The MHRA’s chief safety officer, Dr. Alison Cave, emphasized that while the risk remains low, awareness is crucial. Patients experiencing persistent, radiating stomach pain, accompanied by nausea and vomiting, should seek immediate medical advice. The regulator is also collaborating with Genomics England to study whether genetic factors influence susceptibility to pancreatitis in GLP-1 users.
Industry Response and Ongoing Monitoring
Pharmaceutical companies Novo Nordisk (Wegovy, Ozempic) and Eli Lilly (Mounjaro) both reiterated their commitment to patient safety. Novo Nordisk stressed the importance of using these medications only as prescribed and under strict medical supervision. Lilly emphasized its continuous monitoring of safety data and collaboration with regulatory bodies.
Both firms acknowledge that pancreatitis is listed as an uncommon side effect in product information, advising patients to discuss any concerns with their healthcare provider. The MHRA encourages reporting adverse reactions through the Yellow Card scheme to enhance post-market surveillance.
The MHRA’s updated guidance underscores the need for vigilant monitoring of GLP-1 medications, even as they remain effective for many patients. The agency’s collaboration with Genomics England highlights a shift toward personalized risk assessment in drug safety.
