The UK’s health watchdog is launching a major investigation into the potential risks associated with popular GLP-1 receptor agonist drugs, widely used for weight loss and managing Type 2 diabetes. This action follows hundreds of reports linking these medications, including well-known brands like Ozempic, Mounjaro, and Wegovy, to cases of acute and chronic pancreatitis, a serious and potentially fatal inflammation of the pancreas.
The Medicines and Healthcare products Regulatory Agency (MHRA) has received a significant number of Yellow Card reports detailing instances of pancreatitis in patients using these drugs. Reports linked to Mounjaro alone total 181 cases, including five associated deaths. Similarly, Wegovy and Ozempic are linked to 113 reported pancreatitis cases and one death. Across all reported GLP-1 medicines mentioned in recent data, there have been reports involving a total of 10 associated deaths.
While pancreatitis is a known, albeit uncommon (affecting up to 1 in 100 users), side effect listed in patient information leaflets, the increasing number of reports, coinciding with the rising popularity and usage of these medications, has prompted closer scrutiny. Symptoms of acute pancreatitis are severe and include intense abdominal pain often radiating to the back, nausea, vomiting, and fever, frequently requiring hospitalisation. Although many acute cases resolve, complications can be severe, with around 5% proving fatal.
It’s crucial to note that the MHRA emphasizes that these reports indicate a link based on the Yellow Card scheme data; they do not currently provide definitive proof that the drugs directly caused all reported cases or deaths. Pancreatitis can have other causes, such as gallstones or alcohol consumption, and it occurs in the general population.
Investigating a Potential Genetic Link
To better understand why some individuals might be more susceptible to this side effect, the MHRA is partnering with Genomics England on a pioneering study. Known as the Yellow Card Biobank, this initiative will collect genetic data from patients who have been hospitalised with acute pancreatitis suspected to be linked to their GLP-1 medication use.
The goal is to identify whether specific genetic differences predispose individuals to developing pancreatitis when taking these drugs. Dr. Alison Cave, MHRA Chief Safety Officer, highlighted the potential of this research, stating that genetic testing could potentially prevent a significant proportion of adverse drug reactions. This study represents a key step towards a more personalised approach to medicine, aiming to identify at-risk individuals before they start treatment.
Patients who have experienced hospitalisation for acute pancreatitis while using GLP-1 medicines are strongly encouraged to report their experience through the Yellow Card scheme. Healthcare professionals are also urged to report suspected cases. Eligible participants who report via Yellow Card may be contacted by the MHRA and invited to join the Biobank study by providing a saliva sample via mail for genetic analysis.
Important Considerations for Users
GLP-1 receptor agonists like Ozempic (semaglutide), Mounjaro (tirzepatide), Wegovy (semaglutide), and Rybelsus mimic natural hormones that regulate appetite and blood sugar. Mounjaro uniquely acts on a second hormone as well. In the UK, these powerful medications are licensed specifically for individuals with obesity or Type 2 diabetes and are not approved for cosmetic weight loss.
They must be prescribed by a qualified healthcare professional following a thorough consultation. While available on the NHS in certain cases, they are also accessible privately through legitimate clinics and pharmacies. Experts caution that while the risks associated with obesity often outweigh the rare risk of pancreatitis for approved users, obtaining these drugs for minor weight loss without professional oversight carries less clear benefits compared to potential risks.
A strong warning is issued against purchasing GLP-1 drugs from unregulated sources, including beauty salons or social media platforms. Counterfeit or unauthorised products pose significant health risks and can cause serious side effects. Always ensure you receive genuine medication from a licensed pharmacy with a valid prescription.
Drug manufacturers, including Lilly (Mounjaro) and Novo Nordisk (Ozempic, Wegovy), have stated that patient safety is their utmost priority. They continuously monitor safety data and information leaflets clearly list acute pancreatitis as an uncommon side effect. They advise patients with a history of pancreatitis to consult their doctor before starting treatment and stress the importance of using these medications only for approved indications under strict medical supervision.
As the MHRA’s investigation and the Yellow Card Biobank study progress, users and healthcare professionals are urged to remain vigilant and continue reporting any suspected side effects to help ensure the safe use of these increasingly popular medications.
