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Background

GLP-1RAs are effective and acceptably safe treatments when used within their licensed indications. However, as with all medicines, there are risks associated with their use.

GLP-1RAs are a class of medications used to treat type II diabetes mellitus and obesity. Five GLP-1RAs are available in the UK: dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide. Wegovy, which contains semaglutide, is also licensed as a preventative treatment to reduce the risk of cardiovascular events in patients with established cardiovascular disease. Mounjaro (tirzepatide) is a GLP-1RA combined with glucose-dependent insulinotropic polypeptide receptor agonist (GIP RA).

Some of the GLP-1RA products have more than one brand name and more than one indication. Annex 1 lists the GLP-1RA products currently authorised in the UK with their brand names and indications.

Public interest in the use of GLP-1RA products for weight loss is high. GLP-1RA products licensed for weight reduction are effective treatment options for patients who have obesity (with a BMI above 30kg/m) or who are overweight with weight-related comorbidities (with a BMI above 27kg/m) such as cardiovascular disease. Saxenda (liraglutide), Wegovy (semaglutide) and Mounjaro (tirzepatide) are the only GLP-1RA products licensed for weight management.

There has been anecdotal evidence and adverse drug reaction reports suggesting misuse of GLP-1RA products for weight management by individuals outside of the licensed indication. The benefits and risks of using these medicines for weight loss by individuals who do not have obesity or who are not overweight with weight-related comorbidities have not been studied.

Risk of adverse drug reactions associated with GLP-1RA medicines

To ensure informed decision-making when prescribing GLP-1RAs for weight management, it is important that patients are aware of the potential adverse drug reactions associated with these medicines. These include common gastrointestinal reactions, that, if not managed effectively, can lead to serious complications.

Gastrointestinal side effects are more likely to occur at the start of treatment or after a recent increase in dose. Healthcare professionals should also discuss the serious, but less common risks such as pancreatitis and gall bladder disorders which may occur in between 1 in 100 and 1 in 10,000 patients dependent on the GLP-1RA.

The risk of hypoglycaemia in non-diabetic patients is included in the product information for Saxenda and Wegovy which are licensed for weight management; patients should be made aware of the signs and symptoms of hypoglycaemia and what action to take.

The MHRA has received Yellow Card reports for individuals who have been hospitalised due to suspected adverse drug reactions with GLP-1RAs when used for weight loss. Severe dehydration following gastrointestinal adverse drug reactions has been reported, including for individuals who may not meet the prescribing criteria and may have used these medicines inappropriately for weight loss. It is, however, difficult to confirm the inappropriate use or misuse of medicines from the Yellow Card data.

As of 16 August 2024, the MHRA has received 5073 reports of common gastrointestinal reactions (including nausea, vomiting and diarrhoea) in association with GLP-1RAs indicated for weight management. Of these reports, 46 reported hospitalisation of the individual. Reports have also been received by the MHRA that do not specify a brand name or provide details about indication of use and subsequently have not been included in this data^{[footnote 2]}.

When interpreting this information, it is important to understand that the exact number of individuals using these medicines is unknown. The lack of prescribing data makes it difficult to determine how common an adverse drug reaction is. Additionally, the number of reports can be influenced by actual usage of the medicine, availability of the medicine and length of time since it was licenced for use. Due to the limitations of spontaneous reporting, some reports may lack information on serious outcomes including hospitalisation, and reports that did not report an indication without a brand name have not been included in this data, potentially underestimating the risk. Please also note that some reports may have reported other serious adverse drug reactions which may have also been the primary cause of hospitalisation, unrelated to gastrointestinal adverse drug reactions. Reports have been received that contain more than one common gastrointestinal adverse drug reaction, for example, vomiting and nausea.

Report any suspected adverse drug reactions

Healthcare professionals should continue to report suspected adverse drug reactions to the Yellow Card scheme. When reporting please provide as much information as possible, including information about medical history, any concomitant medication, onset, treatment dates, product brand name, details of your suspicion of inappropriate use or misuse and include all relevant patient details including weight or BMI, and if possible, where the product was obtained (i.e. NHS prescription, private prescription, including online prescriptions, or illegitimate supplier). Reporting suspected ADRs, even those known to occur, adds to knowledge about the frequency and severity of these reactions and can be used to identify patients who are most at risk. Your report helps the safer use of medicines.

Healthcare professionals, patients, and caregivers are asked to submit reports using the Yellow Card scheme electronically using:

• the Yellow Card website
• the Yellow Card app; download from the Apple App Store or Google Play Store
• some clinical IT systems for healthcare professionals (EMIS, SystmOne, Vision, MiDatabank, and Ulysses
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