The pioneering Yellow Card Biobank, launched by the Medicines and Healthcare products Regulatory Agency (MHRA) and Genomics England, is investigating whether the risk of acute pancreatitis from GLP-1 injections for weight loss and type 2 diabetes may be influenced by a person’s genes.
GLP-1 medicines are licensed for type 2 diabetes and weight management, and include the branded products Ozempic, Mounjaro and Wegovy.
Patients who have been hospitalised with acute pancreatitis suspected to be related to 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. The Yellow Card Biobank was launched by MHRA and Genomics England in 2023.
Professor Matt Brown, Chief Scientific Officer of Genomics England, commented: “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.”
Dr Alison Cave, MHRA Chief Safety Officer, added: “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.
Although infrequent, acute pancreatitis has been reported with GLP-1 medicines. The main symptom of this is severe pain in the stomach that radiates to the back and does not go away.
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.
Genomics England is collaborating with the MHRA providing the sequencing and storage of genetic material through use of its well-established and secure infrastructure. Participants’ data will be de-identified and added to the National Genomic Research library, a platform that allows approved researchers to access genomic and other associated health data via a secure research environment.