UK study to investigate genetic risk of acute pancreatitis from GLP-1 medicines

The Yellow Card Biobank has launched a new research initiative to examine whether genetic factors contribute to the risk of acute pancreatitis in patients taking GLP-1 receptor agonists, including Ozempic, Mounjaro, and Wegovy, for the treatment of Type 2 diabetes or weight management.

The Yellow Card Biobank, a joint initiative between the Medicines and Healthcare products Regulatory Agency (MHRA) and Genomics England, is investigating whether inherited genetic traits may predispose certain individuals to acute pancreatitis, a rare but serious adverse effect associated with GLP-1 receptor agonists. While these medicines are widely used and generally well tolerated, they have been linked in a small number of cases to inflammation of the pancreas. Acute pancreatitis typically presents with persistent, severe abdominal pain radiating to the back. This study aims to identify genetic markers associated with increased risk, with the overarching goal of improving patient safety through more targeted prescribing.

The MHRA is actively encouraging patients who have been hospitalized with suspected GLP-1-related acute pancreatitis to report their experience via the Yellow Card scheme. Upon receiving a report, the agency may invite eligible individuals to participate in the Biobank study. Participation involves completing a health questionnaire and providing a saliva sample for genomic analysis. This genetic data will be used to assess whether certain individuals are more likely to experience adverse reactions based on their genetic profile.

Healthcare professionals are also being encouraged to report suspected cases on behalf of patients and may be contacted to facilitate enrolment. All participant data will be de-identified and stored securely, with access granted only to approved researchers within a controlled environment.

The Yellow Card Biobank is part of a broader strategy to advance personalized medicine in the UK. By analyzing genetic variants associated with adverse drug reactions, the study seeks to build the evidence base for incorporating pharmacogenomic testing into clinical practice. According to the MHRA, these insights could eventually support the use of rapid genetic screening tools, enabling healthcare professionals to tailor prescriptions and reduce the risk of harm.

Dr Alison Cave, Chief Safety Officer at the MHRA, highlighted the potential impact:

“Information from the Yellow Card Biobank will help us to better predict those most at risk of adverse reactions – enabling patients across the UK to receive the safest medicine for them, based on their genetic makeup.”

As part of the initiative, Genomics England is providing sequencing and storage infrastructure, with participant data added to the National Genomic Research Library, a secure repository that supports approved research. In addition to GLP-1-related pancreatitis, the Biobank is also studying severe bleeding linked to direct oral anticoagulants (DOACs) and has completed recruitment for severe skin reactions associated with allopurinol.

The initiative reflects a broader goal of using genomics to reduce adverse drug reactions (ADRs), which are responsible for one in six hospital admissions and, “continue to be a significant burden on the NHS.” According to Dr Cave,

“Evidence shows that almost a third of side effects to medicines could be prevented with the introduction of genetic testing. It is predicted that adverse drug reactions cost the NHS more than £2.2 billion a year in hospital stays alone.”

Professor Matt Brown, Chief Scientific Officer at Genomics England, added:

“By joining forces with the MHRA, we are poised to gain greater understanding of these genetic influences – discoveries that will be vital if we are to move to harness the power of genomics to proactively protect patients from these harms.”