Question to the Department of Health and Social Care:

To ask His Majesty's Government, further to the Written Answer by Baroness Merron on 6 July (HL1488), how the Medicines and Healthcare products Regulatory Agency will communicate the conclusions of its review of mental health risks for migraine prophylaxis medications; whether that Agency will consider a drug safety update or other national safety communication; and whether any resulting changes to product information would be reflected in national electronic prescribing and medicines decision-support systems.

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 plans to gather the currently available evidence on mental health and other related risks for licensed migraine prophylaxis medications, as referenced in the separate responses to questions HL1488 and HL1543. A formal timeline for this review has not yet been agreed, and consequently we are unable to provide an expected completion date at this stage.

The MHRA is committed to communicating any findings that may have implications for patient safety or the safe use of medicines. The MHRA will sometimes issue communications, such as drug safety updates, after the conclusion of a review. However, the review is at an early stage, and it would be premature to comment on any potential communication plans. In addition, any product information changes that may arise as a result of this review would be reflected in the published product information available at locations such as the MHRA website or the Electronic Medicines Compendium website.