Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, how the Medicines and Healthcare products Regulatory Agency plans to improve the (a) monitoring and (b) reporting of adverse effects related to weight loss drugs; and what systems are in place to ensure that (i) patients and (ii) healthcare providers can report those effects.

The Yellow Card scheme collects reports of suspected adverse effects for all healthcare products including weight loss drugs. Reporting is open to all healthcare professionals and members of the public through a variety of methods including online, via the Yellow Card app, phone, email and paper forms. To make reporting as quick and easy as possible, there is also direct integration of Yellow Card reporting functionality available within some clinical IT systems. This includes covering over 93% of GP practices across England.

To improve the quality of information captured on a Yellow Card report for weight loss medicines, we have recently introduced a number of additional questions to support ongoing monitoring of the safety of these products and rapid identification of potential safety issues.

Reporting to the scheme is voluntary and therefore requires sustained efforts to promote and raise awareness of the scheme. To promote the reporting of side effects, a call to report side effects is included in all communications for weight loss medicines. For example, the Medicine and Healthcare products Regulatory Agency (MHRA) guidance on GLP-1 medicines contains several links to the Yellow Card Scheme, as do the Drug Safety Updates for healthcare professionals that the MHRA have published relating to these medicines. Reporting has also been encouraged on press releases issued on the illegal sales of GLP-1s and posts on the MHRA social media platforms (X, Instagram and Facebook).

Alongside data collected through the Yellow Card scheme, the MHRA also monitors for adverse events through a variety of other data sources including scientific literature, epidemiological studies, regulatory reports from other countries, and periodic safety data submitted by pharmaceutical companies. All safety concerns are evaluated by our multidisciplinary teams and expert advisory groups, and where necessary, regulatory action is taken.