Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of reports that doctors have been advised to warn asthma patients using the drug Montelukast of potential hallucinations and suicidal thoughts and other side-effects.

Montelukast is effective in the treatment of asthma in adults, adolescents and children aged six months and older who are not adequately controlled on their usual/routine asthma medication and who need additional therapy. Montelukast also helps to prevent the narrowing of airways triggered by exercise. The benefits of montelukast have been shown to outweigh the risks in adults and children.

The very rare risk (up to 1 in 10,000 people) of neuropsychiatric reactions in association with montelukast treatment has been known for some time and information about adverse reactions including hallucinations and suicidal thinking and behaviour (suicidality) are already included in the product information for montelukast.

In September the Medicines and Healthcare Products Regulatory Agency published an article in Drug Safety Update to remind prescribers of the very rare risk of neuropsychiatric reactions with use of montelukast. The article outlines the risks and advises healthcare professionals to evaluate carefully the risks and benefits of continuing treatment with montelukast if neuropsychiatric reactions occur. Healthcare professionals are reminded to report any suspected adverse drug reactions associated with montelukast to the Yellow Card Scheme.