The Medicines and Healthcare products Regulatory Agency (MHRA) today (June 26) called on patients “who have been hospitalised with acute pancreatitis suspected to be related to glucagon-like peptide-1 receptor agonists (GLP-1 RAs)” to report it to the agency’s Yellow Card scheme.
It comes as the MHRA revealed that 10 people in the UK have died after suffering from pancreatitis linked to weight loss jabs.
Read more: Exclusive: Over 100 UK deaths now linked to GLP-1 RAs
The body confirmed to C+D that since GLP-1s were launched, the MHRA has received reports of:
- More than 560 patients developing an inflamed pancreas
- 181 cases of acute and chronic pancreatitis linked to tirzepatide – found in Mounjaro – and five deaths
- 116 cases of acute and chronic pancreatitis linked to liraglutide – found in Saxenda – one of which was fatal
- 113 cases of acute and chronic pancreatitis linked to semaglutide – found in Ozempic and Wegovy – and one death
- 101 cases of acute and chronic pancreatitis linked to exenatide and three deaths
- 52 cases of acute and chronic pancreatitis linked to dulaglutide and 11 linked to lixisenatide, with no fatalities
“Significant burden” on NHS
“Although infrequent, acute pancreatitis has been reported with GLP-1 medicines [and] this can be serious” – with a main symptom of severe pain in the stomach that radiates to the back and does not go away - the MHRA said.
And it announced that its “Yellow Card Biobank” in partnership with Genomics England “will start investigating whether the risk of acute pancreatitis from GLP-1 injections for weight loss and Type 2 diabetes may be influenced by an individual’s genes”.
Read more: Ozempicola? Blair’s weight-loss future swerves around safety
Those who take part in the study will be asked to submit “a saliva or spit sample that 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”, it added.
The MHRA also asked healthcare professionals to “help recruit for the study by reporting Yellow Cards on behalf of patients experiencing acute pancreatitis while taking GLP-1 medicines”.
Read more: ‘Greater weight loss’ than ever: Novo trials triple-strength Wegovy
“Side effects continue to be a significant burden on the NHS and studies have shown they account for one in six hospital admissions,” it said, adding that “screening tests” would provide the opportunity to “reduce the likelihood” of adverse drug reactions.
“The overall aim” of the study is to reduce “the occurrence of these side effects in the future”, the MHRA stressed.
“Safer” treatment
MHRA chief safety officer Dr Alison Cave said that “evidence shows that almost a third of side effects to medicines could be prevented with the introduction of genetic testing”.
“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,” she stressed.
And chief scientific officer of Genomics England Professor Matt Brown said that this partnership with the MHRA will “generate data and evidence for safer and more effective treatment through more personalised approaches to prescription”.
Read more: Exclusive: CPhO confirms Mounjaro pharmacy service on the cards
It comes after C+D exclusively revealed earlier this month that the MHRA has received “a total of 111 UK spontaneous suspected adverse drug reaction (ADR) reports with a fatal outcome” where GLP-1 medicines were used for any reason.
But a week earlier, the chief pharmaceutical officer (CPhO) for England told C+D that there is a “really significant opportunity” for community pharmacy in new weight loss jab services at the NHS Confed Expo in Manchester.
Meanwhile, NHS England (NHSE) national medical director Sir Stephen Powis stressed to conference delegates that “we are at the very early stages of learning how to use these drugs” and “there is more to learn”.
