Question to the Department of Health and Social Care:

To ask Her Majesty's Government what recommendations have been made by the Medicines and Healthcare products Regulatory Agency regarding the prominence of warnings concerning mental health risks associated with the use of Montelukast in children; and what is the timescale for implementation of any such recommendations.

Warnings on mental health risks associated with the use of montelukast in children are included in the product information and in prescribing and other resources available to health professionals and patients. The warnings were strengthened in 2019 and the Medicines and Healthcare products Regulatory Agency issued an alert in its Drug Safety Update bulletin for prescribers. However, in response to concerns raised and in line with independent expert advice, more prominent warnings will be included in product information and patient alert cards and safety leaflets will be provided to patients. These materials are currently being developed and are expected to be introduced later this year.