Safety

UK regulators begin genetic study of GLP-1 pancreatitis cases

UK regulators are collecting saliva samples from patients who developed pancreatitis on a GLP-1 medicine to look for a genetic link; no results or prescribing changes have been announced.

By the Semaglutides news desk·
UK regulators begin genetic study of GLP-1 pancreatitis cases
Image: genomicsengland.co.uk

The UK's Medicines and Healthcare products Regulatory Agency and Genomics England said on June 26, 2025 that they have started investigating whether a person's genes affect their risk of acute pancreatitis from GLP-1 medicines [1].

The work runs through the Yellow Card Biobank, a project the two organizations set up to study how genetic makeup influences the safety of medicines [1]. Patients who have been hospitalised with acute pancreatitis suspected to be related to a GLP-1 medicine — the announcement names Ozempic, Mounjaro and Wegovy as examples — are being asked to file a report with the MHRA's Yellow Card scheme. Healthcare professionals are also being asked to report cases on patients' behalf [1].

When the MHRA receives a report, it contacts the patient to ask whether they will take part in the biobank study. Participants provide more information and a saliva or spit sample [1]. Genomics England will sequence and store the genetic material, and de-identified data will be added to the National Genomic Research library, where approved researchers can study it in a secure environment [1]. The stated goal is to learn whether some people face a higher risk of acute pancreatitis on these medicines because of their genes, and ultimately to reduce how often the side effect happens [1].

Acute pancreatitis has been reported with GLP-1 medicines, though it is described as infrequent. The main symptom listed in the announcement is severe pain in the stomach that radiates to the back and does not go away [1].

Matt Brown, chief scientific officer of Genomics England, said there is "real potential to minimise" serious side effects using genetic information, and that the biobank should "generate data and evidence for safer and more effective treatment through more personalised approaches to prescription" [1]. Alison Cave, the MHRA's chief safety officer, said evidence shows almost a third of side effects to medicines could be prevented with genetic testing, and that adverse drug reactions are predicted to cost the NHS more than £2.2 billion a year in hospital stays alone [1].

Not yet known: how many patients the study aims to enrol, how long it will run, and when results might be published. No findings from the investigation have been released. The announcement gives no breakdown of pancreatitis reports by product, dose, or how long patients had been taking a GLP-1 medicine.

Why it matters for patients

This is the start of a research effort, not a finding. No change to prescribing or to product labelling was announced [1]. As of the announcement, there is no genetic test that can tell a patient whether they are more likely to develop pancreatitis on a GLP-1 medicine. Rapid screening tests that would let healthcare professionals pick the safest medicine based on a patient's genes are described as a long-term aim, not something available now [1].

The investigation is run by UK regulators and recruits through the UK's Yellow Card reporting system, so it does not include US patients [1]. Whether the US Food and Drug Administration or US researchers are running a similar genetics study on GLP-1 pancreatitis has not been reported.

The numbers in the announcement are about medicine side effects in general. The estimate that almost a third of side effects could be prevented with genetic testing, and the £2.2 billion figure for NHS hospital stays, are not specific to GLP-1 medicines [1]. Acute pancreatitis itself is described as an infrequent report with these medicines [1].

What happens next

The MHRA is asking anyone hospitalised with acute pancreatitis while taking a GLP-1 medicine to report it through the Yellow Card scheme, even if they do not meet the criteria for this phase of the biobank study [1]. Recruitment for the saliva samples is open now; the announcement does not give an end date, a recruitment target, or a timeline for results [1]. The stated longer-term plan is to use what the biobank learns to personalise prescriptions with rapid screening tests [1].

Images from the sources

UK regulators begin genetic study of GLP-1 pancreatitis cases
genomicsengland.co.uk

Sources

  1. https://www.genomicsengland.co.uk/news/the-yellow-card-biobank-starts-investigating-glp-1-medicines-and-genetic-risk-of-acute-pancreatitis

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