Seven cases of GLP-1-related acute pancreatitis reported in KOR

A direct causal relationship between these adverse events and the drugs has not yet been clearly established

The Ministry of Food and Drug Safety (MFDS) is closely monitoring adverse event cases...measures to reflect adverse reactions related to optic neuropathy are underway

A total of seven cases of acute pancreatitis following the administration of GLP-1 anti-obesity drugs have been reported in South Korea.

Amid media and online communities reporting emergency room hospitalizations after administration, the Ministry of Food and Drug Safety (MFDS) said it is conducting intensive monitoring of domestic and international adverse events while reviewing plans to add 'ischemic optic neuropathy' to the label warnings for semaglutide products.

According to the MFDS on the 18th, official adverse event reports of acute pancreatitis submitted to the Korea Institute of Drug Safety and Risk Management (KIDS) from post-marketing commercialization through March 2026 totaled four cases for semaglutide formulations (including three serious adverse events) and three cases for tirzepatide formulations (between August 2025 and March 2026). This information was confirmed through the MFDS's official responses to queries from healthcare media press corps.

Recently, major domestic media outlets and online forums reported personal accounts of patients experiencing severe adverse effects following GLP-1 anti-obesity drug administration, drawing heightened societal concern.

In one notable case, a patient experienced severe abdominal pain alongside sharp spikes in pancreatic and liver enzyme levels immediately after a single initial dose of tirzepatide (product name: Mounjaro), requiring two weeks of emergency inpatient care due to risks of pancreatic necrosis and sepsis.

Concurrently, media coverage highlighted key safety issues, including the risks of gastroparesis and bowel obstruction driven by delayed gastrointestinal motility, which is the primary mechanism of GLP-1 agents, as well as loss of lean muscle mass and bone mineral density, alopecia, gallbladder disorders (such as cholelithiasis) associated with rapid weight loss, and recent Western regulatory warnings regarding sudden vision loss and non-arteritic anterior ischemic optic neuropathy (NAION). Furthermore, heightened risks of adverse reactions arising from off-label, non-standardized prescriptions or misuse in individuals who do not meet body mass index (BMI) criteria continue to come under scrutiny.  

Regarding the seven reported cases of acute pancreatitis in South Korea, the MFDS drew a clear line, stating, "The reported cases were not associated with hospitalization, life-threatening events, death, or severe permanent disability/functional impairment," and added, "a direct causal relationship between these adverse events and the drugs has not yet been clearly established."

Addressing the recent regulatory measures and warnings issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA) regarding necrotizing and fatal acute pancreatitis, the MFDS stated, "Relevant adverse reactions are already reflected in the product labeling for tirzepatide, and 'acute pancreatitis' is similarly included in semaglutide labeling," and added, "We are continuously and intensively monitoring international safety data from the US, Europe, and Japan alongside domestic adverse event reports."  

Domestic regulatory measures regarding non-arteritic anterior ischemic optic neuropathy (NAION), a rare ophthalmologic condition highlighted by the European Medicines Agency (EMA), are also being specified. According to the MFDS, one domestic case of 'ischemic optic neuropathy' following semaglutide administration has been reported.  

An MFDS official stated, "We have concluded discussions with the marketing authorization holders based on overseas label updates related to NAION," and confirmed, "Regulatory change procedures to reflect this in domestic package inserts are currently underway."

As GLP-1 class therapeutics are widely utilized across the obesity management landscape, the MFDS plans to maintain an active pharmacovigilance surveillance system for potential safety risks. The MFDS stated, "We are closely monitoring domestic and international safety information, including pancreatitis, gallbladder disorders, and gastrointestinal adverse reactions, and will take prompt label updates and safety measures as soon as additional data is verified."