Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, how many serious, non-fatal, adverse reactions associated with the use of misoprostol have been reported to the Medicines and Healthcare Products Regulatory Agency in each of the last ten years; and how many fatal adverse reactions associated with the use of misoprostol have been reported to the Medicines and Healthcare Products Regulatory Agency in that period.

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.

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. Underlying or concurrent illnesses may be responsible, or the events could be coincidental.

The following table shows the number of Yellow Card reports classified as serious, excluding fatal outcomes, and those with a fatal outcome, received for misoprostol from initial licensing of the medicine up to 13 May 2025:

Reports received via the Yellow Card scheme can contain more than one suspect medicine. It should be noted that misoprostol is used in combination with mifepristone, as such 60 of the serious reports and five reports with a fatal outcome include both products as the suspect drug.

Misoprostol is licenced for a variety of indications, including gastroprotection in duodenal and gastric ulcers, termination of pregnancy, and induction of labour. Mifepristone is licenced for termination of pregnancy and induction of labour.

A list of the possible side effects of mifepristone and misoprostol are provided in the product information document for healthcare professionals, the Summary of Product Characteristics, and in the UK Patient Information Leaflet.

A Yellow Card report is considered serious according to two criteria. Firstly, a reported reaction can be considered serious according to our medical dictionary. Secondly, if the original reporter considers the report to be serious, they can select from the six serious criteria available, which are: patient died due to reaction; life threatening; resulted in hospitalisation or prolonged inpatient hospitalisation; congenital abnormality; involved persistent or significant disability or incapacity; or if the reaction was deemed medically significant.