MHRA and Genomics England start hunting for a genetic cause of GLP-1 pancreatitis

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) and Genomics England have started using their Yellow Card Biobank to look into whether genetics play a role in acute pancreatitis linked to GLP-1 medicines, including Ozempic, Wegovy, and Mounjaro ^[1]. Acute pancreatitis is swelling of the pancreas that causes severe stomach pain radiating to the back, and it does not go away on its own ^[1]. The agencies describe this as one of the first regulator-run efforts to study the genetic side of a GLP-1 safety signal ^[1].

Patients who have been hospitalized with pancreatitis they believe is linked to a GLP-1 medicine are being asked to report it through the UK's Yellow Card scheme ^[1]. Doctors and other health workers are also being asked to file these reports on behalf of patients ^[1]. Once a report comes in, the MHRA will reach out to ask if the patient wants to join the Biobank study, which involves giving more details and providing a saliva sample ^[1]. Genomics England will sequence and store the genetic material, then strip it of identifying details before adding it to a research library that scientists can apply to use ^[1].

The agencies say the pancreatitis reports are infrequent, but they want to understand why some people develop this reaction while most do not ^[1]. Dr. Alison Cave, the MHRA's Chief Safety Officer, said research shows that almost a third of medicine side effects could be prevented with genetic testing, and that adverse drug reactions cost the UK's National Health Service more than £2.2 billion a year in hospital stays alone ^[1]. Professor Matt Brown, Chief Scientific Officer at Genomics England, said many adverse reactions have a genetic cause and that this data could support more personalized prescribing decisions in the future ^[1].

Why it matters for patients

This study is being run in the United Kingdom, not the United States, and it applies to people using the UK health system ^[1]. Still, the drugs involved—semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro)—are the same molecules sold in the US, so findings about who is more likely to develop pancreatitis could eventually matter to US prescribers and patients as well ^[1]. Right now, the sources do not say whether any similar genetic study is planned or underway in the US.

For patients currently taking a GLP-1 medicine, the news does not change how the drugs are prescribed or labeled today. It signals that regulators are trying to move from broad warnings toward figuring out which patients face higher risk based on their genes, with the stated goal of eventually helping prescribers choose the safest medicine for a given person ^[1]. That kind of personalized prescribing, if it happens, is still a distant goal rather than something available now.

What happens next

The MHRA says it will keep collecting Yellow Card reports and saliva samples from patients hospitalized with suspected GLP-1-related pancreatitis, and it is encouraging both patients and healthcare professionals to file reports even if they do not qualify for this study phase, since any adverse reaction data helps improve medicine safety monitoring ^[1]. The sources do not include a timeline for when results from the genetic analysis might be published or how many participants researchers hope to enroll.