Five deaths and hundreds of illnesses 'linked to weight-loss jabs'

Hundreds of people have reported health issues with their pancreas allegedly linked to weight loss and diabetes injections. The claims have led health officials to launch a new study into potential side effects.

Some instances of pancreatitis, allegedly connected to GLP-1 medicines (glucagon-like peptide-1 receptor agonists), have resulted in fatalities. Data from the Medicines and Healthcare products Regulatory Agency (MHRA) revealed that since these drugs were approved, there have been hundreds of cases of acute and chronic pancreatitis among those taking GLP-1 medicines. A total of 10 people are said to have died, with five reportedly linked to the active ingredients of some popular medicines.

The data showed:

• 181 reported cases of acute and chronic pancreatitis linked to tirzepatide – the active ingredient for Mounjaro. Five people died.
• 116 reported reactions of this kind linked to liraglutide, one of which was fatal.
• 113 cases of acute and chronic pancreatitis linked to semaglutide – the active ingredient for Ozempic and Wegovy - neither of which are weight-loss jabs. One person died.
• 101 reported reactions of this kind linked to exenatide, three people died.
• 52 reported reactions of this sort linked to dulaglutide and 11 reported reactions to lixisenatide. No fatalities were linked to either drug.

These incidents are not confirmed as being caused by the medications, but the people who reported them suspect they might be the cause.

Now the Yellow Card Biobank project, launched by the MHRA and Genomics England, will investigate whether instances of pancreatitis linked to GLP-1 drugs could be influenced by people's genetic make-up.

The MHRA is urging people taking GLP-1 medicine who have been hospitalised due to acute pancreatitis to submit a report to its Yellow Card scheme.

Upon receipt of a Yellow Card report, the MHRA will contact patients to inquire if they would be willing to participate in the study.

Patients are set to provide additional details and a saliva sample for analysis to determine if genetic factors increase the risk of acute pancreatitis from certain medications.

GLP-1 agonists, which are used to reduce blood sugar in type 2 diabetes and aid weight loss, are under scrutiny, reports Wales Online.

With about 1.5 million Brits using weight loss injections, health chiefs acknowledge their potential in battling obesity but caution against viewing them as a cure-all, highlighting possible side effects.

Common adverse reactions to these jabs include nausea, constipation and diarrhoea, while recent alerts have been raised about Mounjaro's potential to diminish the effectiveness of the contraceptive pill.

Dr Alison Cave, MHRA's 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 could cost the NHS more than £2.2bn a year in hospital stays alone.

"Data from the Yellow Card Biobank will enable us to better identify individuals at higher risk of adverse reactions, allowing patients across the UK to receive the safest medication for them based on their genetic profile.

"To assist us in helping you, we urge anyone who has been hospitalised with acute pancreatitis while taking a GLP-1 medication 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, the 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."

Eli Lilly, which makes Mounjaro, said in a statement: "Patient safety is Lilly's top priority. We take reports regarding patient safety seriously and actively monitor, evaluate and report safety information for all our medicines.

"Adverse events should be reported under the MHRA's Yellow Card scheme, but may be caused by other factors, including pre-existing conditions.

"The Mounjaro (tirzepatide) Patient Information Leaflet warns that inflamed pancreas (acute pancreatitis) is an uncommon side effect (which may affect up to 1 in 100 people). It also advises patients to talk to their doctor or other healthcare professional before using Mounjaro if they have ever had pancreatitis.

"We encourage patients to consult their doctor or other healthcare professional regarding any side effects they may be experiencing and to ensure that they are getting genuine Lilly medicine."

Novo Nordisk, the makers of Ozempic and Wegovy, told the Express in a statement: "Patient safety is of the utmost importance to Novo Nordisk. GLP-1 receptor agonists (GLP-1 RAs) have been used to treat type 2 diabetes (T2D) for more than 15 years including Novo Nordisk products such as semaglutide and liraglutide that have been on the market for more than 10 years.

"Semaglutide has been extensively examined in robust clinical development programmes and real world evidence studies. A total of more than 25,000 participants have been exposed to semaglutide injection for T2D, and semaglutide injection for weight management in completed clinical studies conducted by Novo Nordisk.

"We recommend patients take these medications for their approved indications and under the supervision of a healthcare professional. Treatment decisions should be made together with a healthcare provider who can evaluate the appropriateness of using a GLP-1 based on assessment of a patient's individual medical profile.

"We continuously collect safety data on our marketed GLP-1 RA medicines and work closely with the authorities to ensure patient safety. As part of this work, we continue to monitor reports of adverse drug reactions through routine pharmacovigilance. 

"We recommend that any patient experiencing side effects while taking GLP-1 receptor agonists including Wegovy and Ozempic (semaglutide injection) and report them to their healthcare provider and via the MHRA Yellow Card scheme."