MHRA reminds healthcare professionals to advise patients of the side effects of GLP-1 agonists and to report misuse
The Medicines and Healthcare products Regulatory Agency (MHRA) is reminding healthcare professionals to ensure patients are aware of the known side effects of glucagon-like peptide-1 (GLP-1) receptor agonists.
These medicines are used to treat type 2 diabetes or obesity, with the common risk of gastrointestinal side effects which may affect more than 1 in 10 patients. While most side effects for these medicines are mild, some may also be serious.
Healthcare professionals should also be alert for signs of misuse of these medicines in their patients, warn these patients that they are at risk of side effects and report any adverse reactions via the Yellow Card scheme.
GLP-1 receptor agonists approved for weight management, are effective treatment options for patients with a Body Mass Index (BMI) higher or equal to 30 kg/m2 or for patients whose BMI is higher or equal to 27 kg/m2 and have a weight-related medical condition, such as cardiovascular disease.
GLP-1 receptor agonists can only be prescribed by a registered healthcare professional.
When appropriately used in line with the product licence, the benefits of these medications outweigh the risks for patients. However, this benefit-risk balance is positive only for those patients within the approved indications for weight management or type 2 diabetes as described in the product information.
If patients obtain a private prescription (from a non-NHS prescriber), they should ensure this is dispensed from an authorised source, such as a registered pharmacy, to avoid the risk of receiving a falsified pen. They should be aware that some falsified medicines have been found to contain insulin, which if used, could cause severe hypoglycaemia (low blood sugar) requiring urgent medical attention.
It is vital for patients to carefully read the instructions in the Patient Information Leaflet and use the prescribed dose. Potential side effects of these medicines can include gastrointestinal conditions, such as vomiting and diarrhoea. In most cases, these are not usually serious, but may sometimes lead to more serious complications such as severe dehydration, resulting in hospitalisation. Patients are advised to stay hydrated by drinking plenty of fluids throughout treatment.
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 risk of serious, but less common side effects such as pancreatitis and gall bladder disorders.
Hypoglycaemia (low blood sugar) can occur in non-diabetic patients using some GLP-1 receptor agonists for weight management and healthcare professionals should ensure patients are aware of the symptoms and signs of this condition, such as sweating, shaking, feelings of tiredness or weakness and confusion. Where this occurs, patients should eat or drink something that will raise their blood sugar quickly, and if symptoms persist they should seek medical attention.
Patients prescribed GLP-1 receptor agonists should speak to a healthcare professional if they have any questions about potential side effects.
Dr Alison Cave, MHRA Chief Safety Officer, said:
“All medicines carry a risk of potential side effects and GLP-1RAs are no exception.
“We encourage healthcare professionals to ensure patients being treated with these medicines are aware of the common side effects and how to minimise risk.
“The balance of benefits and risks outside the licensed indication has not been shown to be favourable. Please report cases of misuse especially if harm occurs”
Wes Streeting, Secretary of State for Health and Social Care, said:
“Weight-loss drugs have enormous potential. When taken alongside healthy diet and exercise, they can be game changers in tackling obesity and getting people back to good health.
“But these are not cosmetic drugs that should be taken to help get a body beautiful picture for Instagram. These are serious medicines and should only be used responsibly and under medical supervision. They’re not a quick fix to lose a few pounds and buying them online without appropriate assessment can put people’s health at risk.
“Drugs approved for weight management should only be used by those tackling obesity, where diet and exercise has been tried first, and where patients are eligible.”
Healthcare professionals should consult our Drug Safety Update for further advice.
ENDS
Notes to editors
- Further information is available in the Drug Safety Update.
- GLP-1 receptor agonists are used to treat type 2 diabetes and obesity, with active ingredients including exenatide, lixisenatide, liraglutide, dulaglutide, semaglutide and tirzepatide. They work by mimicking the action of the natural hormone GLP-1, which helps regulate blood sugar levels by stimulating insulin secretion, reducing glucagon secretion, slowing gastric emptying, and promoting satiety.
- Not all GLP-1 receptor agonists are approved for weight management, products can include the active ingredients semaglutide (Wegovy), tirzepatide (Mounjaro) and liraglutide (Saxenda). GLP-1 receptor agonists can be used alone or in combination with other diabetes medications. Some GLP-1 receptor agonists have also been approved for weight management in obese patients with a body mass index (BMI) greater than 30 kg/m² or overweight patients with a BMI of 27 kg/m.
- Symptoms of hypoglycaemia (low blood sugar) can be found on the NHS website.
- Falsified medicines can cause a serious risk to health, patients should only receive prescriptions from authorised prescribers.
- A licensed indication refers to the approval to treat or manage a specific medical condition.
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
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