Insights

MHRA to investigate links between genetics, GLP-1 drugs and pancreatitis

Market Insight 2025年7月1日 2025年7月1日
英国和欧洲
Regulatory movement
保险和再保险

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched an investigation into whether an individual’s genes may increase their risk of developing acute pancreatitis when taking GLP-1 drugs for weight loss and Type 2 diabetes.

The investigation follows reports submitted to the MHRA’s Yellow Card scheme purportedly linking GLP-1 drugs to numerous deaths, and adverse reactions, the bulk of which were comprised of gastrointestinal disorders. The reports break down as follows:

Semaglutides (with brand names including Ozempic and Wegovy): 18,046 adverse reactions, 1,765 serious reports and 16 fatal outcomes.
Tirzepatides (with brand names including Mounjaro): 20,882 adverse reactions, 3,116 serious reports and 21 fatal outcomes.
Liraglutide (with brand names including Saxenda and Victoza): 2,905 adverse reactions, 688 serious reports and 18 fatal outcomes.

Extracted from Yellow Card website, 27 June 2025 - What is being reported | Making medicines and medical devices safer

Whilst it should be stressed that these reports are unverified, reflecting suspected or potential links between GLP-1 drugs and adverse outcomes, the reports raise necessary questions in the context of the risk/benefit of GLP-1 drugs and broader risk landscape, which includes:

A huge increase in the use of GLP-1 drugs, with estimates suggesting that 1.5M people in the UK may be taking privately funded weight loss injections, with a further 220,000 expected to receive Mounjaro, after it recently became available via the NHS.
The suggestion of a causative relationship between GLP-1 drugs and pancreatitis, including:
- A research paper published in the BMJ linking GLP-1 drugs to an increased risk of gastrointestinal events, including pancreatitis, gastroparesis, and bowel obstruction.
- The US Food and Drug Administration’s Adverse Events Reporting System (FAERS) receiving 908 reports of Ozempic users developing pancreatitis.
The developing litigation in the US, which is centred around a large multi-district litigation against Eli Lilly (the manufacturer of Trulicity and Mounjaro) and Novo Nordisk (the manufacturer of Ozempic, Wegovy, and Rybelsus) in relation to alleged personal injuries. Whilst the alleged injuries include pancreas damage, the litigation is more strongly focused on other injuries, chiefly, gastroparesis, bowel blockage and vision problems. The claims comprise various causes of action, including failure to warn, negligence, misrepresentation and breaches of consumer protection legislation/unfair trade practices.
The extent to which, if at all, the MHRA’s investigation might impact clinical trials, including an ongoing NHS trial, which seeks to measure the “real-world” public health impact of weight loss drugs, including their impacts on prospects of employment and number of sick days taken. The trial involves around 3,000 people in the Greater Manchester area, and is set to take place over a 5 year period.

Pending further clarification of the role (if any) that an individual’s genetics may play in the development of pancreatitis, there would be no obvious need for any or any immediate change in underwriters’ approach to GLP-1 drugs. The Market will, no doubt, be monitoring the position with interest.