Question to the Department of Health and Social Care:

To ask His Majesty's Government whether they are satisfied that the Medicines and Healthcare products Regulatory Agency undertook a sufficiently rigorous approach to the licensing of montelukast, in view of the US Food and Drug Administration’s black box warning about its use.

The Medicines and Healthcare products Regulatory Agency (MHRA) actively reviews the safety and efficacy of medicines throughout their life cycle. As well as through the licensing process itself, this is done via the Yellow Card safety reporting system, the actions of other international regulators, and patient feedback.

The MHRA updated the United Kingdom’s product information on using montelukast in 2019, to provide clearer warnings about the risk of neuropsychiatric side effects. The MHRA is currently conducting a further review of the safety data, and will communicate any changes when that review is concluded.