Question to the Department of Health and Social Care:

To ask His Majesty's Government what plans the Medicines and Healthcare Products Regulatory Agency has to undertake an indication-specific review of suspected adverse drug reaction reports recorded within the Psychiatric Disorders System Organ Class for medicines used in migraine prophylaxis.

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department with responsibility for ensuring medicines meet appropriate standards of quality, efficacy, and safety.

The MHRA has recently received a report relating to the use of migraine medicines and the effect on mental health from a patient. As a result, the MHRA plans to gather the currently available evidence on mental health and related risks for licensed migraine prophylaxis medications and consider whether this suggests a need to update or change existing warnings in the relevant product information. The review would include an assessment of suspected adverse drug reactions recorded within the Psychiatric Disorders System Organ Class in relation to licensed migraine prophylaxis medication use as well as other data sources such as scientific literature.

The MHRA encourages anyone to report if they suspect an adverse reaction to a medical product or products. Further information on Yellow Card reporting is available at the Yellow Card website.