wrans/answers2025-03-07 conversation_156
Source: hansard.parliament.uk (2025-03-07)

UK Parliament Hansard data: wrans/answers2025-03-07 conversation_156

Mr Tanmanjeet Singh Dhesi:To ask the Secretary of State for Health and Social Care, what estimate he has made of the number of people who have been hospitalised as a result of weight loss drugs in each of the last five years. \p Karin Smyth: The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring medicines, medical devices, and blood components for transfusion meet applicable standards of safety, quality, and efficacy. The MHRA rigorously assesses the available data, including from the Yellow Card scheme, and seeks advice from their independent advisory committee, the Commission on Human Medicines, where appropriate, to inform regulatory decisions.

Patient safety is our top priority, and no medicine would be approved unless it met our expected standards of safety, quality and effectiveness. Our role is to continually monitor the safety of medicines during their use, including GLP-1 receptor agonists (RAs). We have robust, safety monitoring and surveillance systems in place for all healthcare products.  When a safety issue is confirmed, we always act promptly to inform patients and healthcare professionals and take appropriate steps to mitigate any identified risk. New medicines, such as GLP-1 RAs, are more intensively monitored to ensure that any new safety issues are identified promptly.

It is important to note that a reaction reported to the Yellow Card scheme does not necessarily mean it has been caused by the medicine, only that the reporter had a suspicion it may have been. Underlying or concurrent illnesses may be responsible, or the events could be coincidental.

On the basis of the current evidence, the benefits of GLP-1 RAs outweigh the potential risks when used for the licensed indications. The decision to start, continue, or stop treatments should be made jointly by patients and their doctor, based on full consideration of the benefits and risks. We strongly encourage patients and healthcare professionals to continue reporting suspected side effects to GLP-1 RAs through our Yellow Card scheme.

From the point of licensing up to and including 31 January 2025, the MHRA has received 573 Yellow Card reports for GLP-1 RAs indicated for weight management, where the patient was reported to have been hospitalised.

As the use of the GLP-1 RAs increases, so have the number of Yellow Card reports associated with these medicines. Yellow Card reporting rates can be influenced by many factors, including the seriousness of the adverse drug reactions, their ease of recognition, and the extent of the use of a particular product. Reporting can also be stimulated by publicity and awareness of a product.

The majority of Yellow Card reports for these medicines concern gastrointestinal effects such as nausea, vomiting, and diarrhoea, which are listed as recognised side effects within the product information for these products. These side effects were observed in the clinical trials for these products, with most events being mild to moderate in severity and of short duration. However, they can sometimes lead to more serious complications such as severe dehydration, resulting in hospitalisation.

Saxenda (liraglutide) and Wegovy (semaglutide) are both approved for weight management in adults with obesity, or for those who are overweight with at least one weight-related comorbidity, as well as in adolescents with obesity. Wegovy (semaglutide) is additionally indicated to reduce the risk of serious cardiovascular problems in adults. Mounjaro (tirzepatide) is indicated for both type 2 diabetes and weight management in adults with obesity or overweight and at least one weight-related comorbidity. Ozempic (semaglutide) has been authorised for the treatment of insufficiently controlled type 2 diabetes mellitus in adults. Ozempic is not authorised for weight loss but is sometimes used off-label for that purpose.