Patients who have been hospitalised for acute pancreatitis after using glucagon-like peptide-1 (GLP-1) receptor agonists are being urged to report this through the Yellow Card scheme as part of an investigation into whether this side effect may be influenced by genetics.
The Medicines and Healthcare products Regulatory Agency (MHRA) has partnered with Genomics England to look into the issue in detail, with the aim of reducing the occurrence of these side effects through personalised treatment approaches in future.
Healthcare professionals are also being encouraged to submit a Yellow Card report on behalf of impacted patients to support recruitment to the project.
Patients aged 18 or over who have had acute pancreatitis flagged as a side effect of GLP-1 medicines through the Yellow Card scheme will be contacted by the MHRA to take part in a Yellow Card Biobank study to investigate risk factors, the medicines regulator said.
This will involve providing further information and submitting an at-home saliva or spit sample, which will be used to explore whether some people are at a higher risk of acute pancreatitis when taking these medicines due to their genetic make-up.
Commenting on the project, Professor Matt Brown, chief scientific officer of Genomics England, said: ‘GLP-1 medicines like Ozempic and Wegovy have been making headlines, but like all medicines there can be a risk of serious side effects. We believe there is real potential to minimise these with many adverse reactions having a genetic cause.
‘This next step in our partnership with the MHRA will generate data and evidence for safer and more effective treatment through more personalised approaches to prescription, supporting a shift towards an increasingly prevention-focused healthcare system.’
According to Dr Alison Cave, MHRA chief safety officer, ‘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 £2.2bn a year in hospital stays alone.’
This is the second investigation currently underway by the Yellow Card Biobank after it began recruiting patients in February 2024 who experienced severe bleeding after taking direct oral anticoagulants.
Calls for vigilance to signs of acute pancreatitis
This latest Yellow Card Biobank project comes as researchers urged healthcare professionals to be vigilant to signs of acute pancreatitis in patients who are taking GLP-1 receptor agonists alongside issuing evidence-based guidance for those working in primary care on how to manage these patients.
Among the recommendations from the team at King’s College London and the University of East Anglia is routinely asking patients about the use of GLP-1 medicines – whether purchased privately or prescribed on the NHS – and watching out for red flag symptoms such as severe abdominal pain, which may signal acute pancreatitis or biliary disease.
Prescribers should also consider the need to alter doses of other medications such as insulin, sulphonylureas and antihypertensives to avoid hypoglycaemia and postural hypotension as weight reduces, the paper in the journal Obesity Facts advised.
Lead author Dr Laurence Dobbie, academic clinical fellow in general practice at Kings College London, said: ‘More than a million people are taking these medicines privately and seeing GPs with lots of different problems.
‘We want GPs to have the basic knowledge to prioritise patient safety and demystify side effects. I’ve seen patients in primary care who are clearly taking the medications, but they haven’t been given wrap-around care.’
The guidance is the first output of the Obesity Management Collaborative UK (OMC-UK) – a network set up in 2024 to provide education and professional development for clinicians in supporting the management of patients with obesity.
OMC-UK chair Professor Barbara McGowan, consultant and honorary senior lecturer in diabetes and endocrinology at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, said: ‘These 10 top tips aim to upskill GPs in the management and monitoring of patients on these medications. By embedding these recommendations into routine clinical practice, we can ensure patient safety and optimise the care of individuals living with obesity.’
