The pioneering Yellow Card Biobank, launched by the Medicines and Healthcare products Regulatory Agency (MHRA) and Genomics England, will start investigating whether the risk of acute pancreatitis (inflamed pancreas) from GLP-1 injections for weight loss and Type 2 diabetes may be influenced by an individual’s genes.
Patients who have been hospitalised with acute pancreatitis suspected to be related to glucagon-like peptide-1 receptor agonists (GLP-1 medicines), such as Ozempic and Mounjaro, are being asked to report it to the MHRA’s Yellow Card scheme. These medicines are sometimes referred to colloquially as “skinny jabs” although they are licensed for both weight loss and Type 2 diabetes.
Healthcare professionals are also being asked to help recruit for the study by reporting Yellow Cards on behalf of patients experiencing acute pancreatitis while taking GLP-1 medicines.
When a Yellow Card report is received, the MHRA will contact patients to ask if they would be willing to take part in the Biobank study. This would involve providing further information and submitting a 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 makeup, with the overall aim of reducing the occurrence of these side effects in the future.
Dr Alison Cave, MHRA Chief Safety Officer said
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.
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.
To help us help you, we’re asking anyone who has been hospitalised with acute pancreatitis while taking a GLP-1 medicine to report this to us via our Yellow Card scheme.
Even if you don’t meet the criteria for this phase of the biobank study, information about your reaction to a medication is always extremely valuable in helping to improve patient safety.
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.
Although infrequent, acute pancreatitis has been reported with GLP-1 medicines. This can be serious. The main symptom of this is severe pain in the stomach that radiates to the back and does not go away. Anyone who experiences this should seek immediate medical help.
The Yellow Card Biobank aims to help understand how a patient’s genetic makeup can impact the safety of their medicines and forms part of a long-term vision for more personalised medicine approaches. Approved scientists will use the genetic information in the Yellow Card Biobank to investigate whether a side effect from a medicine was caused by a specific genetic trait. Ultimately this will enable healthcare professionals to personalise prescriptions using rapid screening tests, so patients across the UK will receive the safest medication for them, based on their genetic makeup.
Side effects continue to be a significant burden on the NHS and studies have shown they account for one in six hospital admissions. Screening tests provide the opportunity to reduce the likelihood of these adverse drug reactions from happening.
The MHRA will request a saliva sample from everyone who takes part in the Yellow Card Biobank study. Saliva testing kits will be posted to participants at their home. It is quick and easy to provide a sample. Instructions will be provided along with a prepaid postage envelope.
Notes to Editors
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Glucagon-like peptide-1 receptor agonists (GLP-1 or GLP-1 RAs) are medicines that help people feel fuller by mimicking a natural hormone released after eating. Some newer medicines, like Mounjaro, also act on a second hormone involved in appetite and blood sugar control. These have been referred to in the media as “weight loss injections” or “skinny jabs”, but not all are authorised for weight loss.
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The Yellow Card Biobank is looking to recruit patients across the UK aged 18 or over who were hospitalised after experiencing acute pancreatitis after taking a GLP-1 medicine. If you are unsure whether you are or were taking one of these medicines, check the label to see what the active ingredient is – it should say semaglutide, liraglutide, lixisenatide, dulaglutide, exenatide or trizepatide. Alternatively, speak to a healthcare professional.
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Healthcare professionals are asked to report Yellow Cards on behalf of patients who are taking GLP-1 medicines (including dual GLP-1 and GIP agonists) and experience acute pancreatitis. While completing the Yellow Card, select “Yes” when asked if you agree to be contacted about the Yellow Card Biobank. If the patient is eligible, the team will be in touch to ask for your help in contacting the patient. The Yellow Card Biobank also works directly with healthcare professionals to refer patients, please see the website for more information or to get in touch with the team.
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The MHRA has issued recent guidance on how to use these medicines safely.
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The first phase of the Biobank campaign was to recruit patients who experienced severe reactions to direct oral anticoagulants (DOACs) and allopurinol.
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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Genomics England is a company established and wholly owned by the Department for Health and Social Care. It is a global leader in enabling genomic medicine and research, focused on creating a world where everyone benefits from genomic healthcare. Building on the 100,000 Genomes Project, it supports the NHS’s world-first national whole genome sequencing service and runs the growing National Genomic Research Library alongside delivering numerous major genomics initiatives.
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This project forms part of the Government’s Life Sciences Vision.
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