Question to the Department of Health and Social Care:

To ask His Majesty's Government whether the Medicines and Healthcare products Regulatory Agency plans to add warnings about sexual dysfunction to the antidepressant mirtazapine after reviewing Yellow Card reports as part of the recent expert working group on antidepressants.

The risk of sexual dysfunction associated with antidepressants, including mirtazapine and vortioxetine, remains under close monitoring by the Medicines and Healthcare products Regulatory Agency (MHRA). The currently approved product information for mirtazapine lists priapism, prolonged painful erection, as a possible side effect during treatment, however, no other forms of sexual dysfunction are currently included in the product information.

For vortioxetine, a serotonin modulator, the approved product information includes information about the dose-related effects of vortioxetine on the risk of sexual dysfunction. Following the recommendations of the expert working group (EWG), the MHRA is currently assessing a safety evaluation report submitted by a marketing authorisation holder refuting the potential association between vortioxetine and post SSRI sexual dysfunction “PSSD” and proposing monitoring only.

The EWG’s recommendation to include a warning on “PSSD” applies only to those antidepressants for which there is sufficient supporting evidence from available sources, including Yellow Card reports and published scientific literature.

I refer the Noble Lord to the Public Assessment Report issued by the MHRA on 15 October 2026, a copy of which is attached.