Increase in number of cases of acute and chronic pancreatitis linked to GLP-1 medicines

Data from the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has revealed that since glucagon-like peptide-1 receptor agonists (GLP-1) were licensed there have been hundreds of cases of acute and chronic pancreatitis among people taking GLP-1 medicines. However, these cases are not confirmed as being caused by the medicines.

As a result, the MRHA and Genomics England has launched the Yellow Card Biobank project, that will enable researchers to examine whether cases of pancreatitis linked to GLP-1 drugs are influenced by a person’s genetic makeup. The MHRA is calling for people who are taking GLP-1 medicine who have been admitted to hospital due to acute pancreatitis to submit a report to its Yellow Card scheme.

Patients will be asked to submit more information and a saliva sample which will be assessed to explore whether some people are at a higher risk of acute pancreatitis when taking these medicines due to their genes.

The MRHA have reported:

• 181 cases of acute and chronic pancreatitis linked to tirzepatide, there were five fatalities.

• 116 reactions to liraglutide, there was one fatality.

• 113 cases of acute and chronic pancreatitis linked to semaglutide, there was one fatality.

• 101 reactions to exenatide, there were three fatalities.

• 52 reactions to dulaglutide and 11 reported reactions lixisenatide, no fatalities were reported.

“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 could cost the NHS more than £2.2 billion a year in hospital stays alone,” said Dr Alison Cave, MHRA’s Chief Safety Officer.

“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.”

“We believe there is real potential to minimise these with many adverse reactions having a genetic cause,” added Professor Matt Brown, Chief Scientific Officer of Genomics England. “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.”

"Patient safety is of the utmost importance to Novo Nordisk. Like all medications, side effects can occur and vary from patient to patient. The known risks and benefits of GLP1 medicines are described in the Summary of Product Characteristics,” Novo Nordisk UK said in a statement. “We recommend that patients take these medications only for their approved indications and under the strict supervision of a healthcare professional, who can also advise on potential side effects."