From appetite suppression to social-media hype, ‘glucagon-like peptide-1 (GLP-1) medicines’ have transformed the conversation around obesity treatment. But their rise has added fresh urgency to the enduring question, ‘Why do some patients experience severe side effects while others don’t?’
Adverse drug reactions (ADRs) currently account for one in six hospital admissions, with an estimated cost to the NHS of over £2 billion annually.1 ADRs represent a significant burden on patients, clinicians and the healthcare system as a whole. Hence, there is both an economic and a public health imperative to better manage ADRs.
'We are asking healthcare professionals to submit Yellow Card reports on behalf of patients taking GLP-1 medicines who develop acute pancreatitis.'
Personalised medicine offers a new opportunity to reduce, or even prevent, ADRs before they occur. The Government’s recent ‘10 Year Health Plan for England’ highlights the potential of pre-emptive testing before prescription to increase both the effectiveness and the safety of medicines.2
GLP-1 receptor agonists and dual GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists (or ‘GLP-1 medicines’) are a relatively new class of drugs with a number of recognised side effects, particularly during the first months of use.3 These medicines are often viewed as a breakthrough in supporting weight management and treating obesity.4 However, careful safety monitoring is essential, and pharmacogenomic research may assist with ensuring these medicines continue to be both safe and effective.
THE MHRA’S ROLE AND GUIDANCE
The Medicines and Healthcare products Regulatory Agency (MHRA) plays a central role in ensuring that medicines used in the UK remain safe and effective throughout their lifecycle. For all medicines, including GLP-1 medicines, this means continuously reviewing safety data as new information emerges, and communicating findings through regular safety communications and guidance available on the MHRA website.5
THE YELLOW CARD SCHEME
The MHRA continuously gathers and evaluates suspected ADRs via the Yellow Card scheme, which plays a vital role in tracking the safety of medicines in real world use.6 New medicines are closely monitored to ensure that any emerging safety concerns are identified promptly.
Recently authorised GLP-1 medicines are included in the Black Triangle scheme, meaning that healthcare professionals are asked to report all suspected ADRs for these products through the Yellow Card scheme.7 Healthcare professionals can also subscribe to the MHRA’s Drug Safety Update for the latest advice and regulatory news.8
THE YELLOW CARD BIOBANK PILOT STUDY
The Yellow Card Biobank is a collaboration between the MHRA and Genomics England designed to improve our understanding of how a patient’s genetic makeup might increase their risk of side effects.9 By taking part, patients contribute to research that could explain why some individuals experience ADRs while others do not.
The Biobank expands the utility of the Yellow Card scheme by inviting patients, or healthcare professionals reporting on their behalf, to support the study. Participants can access study information and sign up online or by post, answer a short questionnaire and provide a saliva sample using a kit delivered to their home. The samples are whole-genome sequenced, and the resulting data will be hosted in the Genomics England Research Environment for analysis by MHRA, Genomics England and the research community.10
GLP-1 MEDICINES AND ACUTE PANCREATITIS
Pancreatitis, specifically in its acute form, is a clinical diagnosis associated with GLP-1 medicines, and the focus of both regulatory reviews and Biobank recruitment. It is a recognised but uncommon side effect of GLP-1 receptor agonists, and is included in the product information for these medicines. While cases have been observed in both clinical trials and post-marketing settings, the biological mechanisms and potential genetic factors remain unclear.
The Yellow Card Biobank is now investigating whether an individual’s genes may influence their risk of developing acute pancreatitis while taking GLP-1 medicines. This work could help explain why only a small number of people are affected, and also support more tailored, evidence-based, regulatory decisions in the future.
RECRUITMENT
Until January 2026, the Biobank is recruiting patients aged 18 years and over from across the UK, who have been hospitalised with acute pancreatitis after taking a GLP-1 medicine for any indication, including weight loss. Cases of pancreatitis caused by gallstones or bile duct stones, which can occasionally occur following rapid weight loss, are excluded from the study.
HOW HEALTHCARE PROFESSIONALS CAN HELP
We are asking healthcare professionals to submit Yellow Card reports on behalf of patients taking GLP-1 medicines who develop acute pancreatitis. Please provide as much detail as possible when completing the form, selecting ‘Yes’ when asked whether you agree to be contacted about the Yellow Card Biobank.
If the patient is eligible, the Biobank team will contact you for help in reaching out to the patient. Further participation will always be the patient’s choice. The Yellow Card Biobank also welcomes direct contact from healthcare professionals with patients who may be eligible.
For more information about the study, or to make a request to access the data, email the study team on [email protected].
JESSICA WRIGHT Head of Yellow Card Biobank, MHRA
NICOLETTA CHAROLIDI Leading Senior Benefit−Risk Assessor for Diabetes and Weight Loss Medicines, MHRA
