Further measures are to be introduced to ensure patients being prescribed montelukast for the treatment of asthma are informed of the risk of neuropsychiatric reactions.

New boxed warnings are being added to patient information leaflets (PIL) to make these risks more prominent, the MHRA has advised in a Drug Safety Update.

The warnings advise patients and healthcare professionals that they should be alert to serious behaviour and mood-related changes associated with the treatment, and patients should immediately speak to their prescriber or seek urgent medical attention if neuropsychiatric reactions occur.

The move follows the outcome of an MHRA review which found that these reactions are typically uncommon, and more serious reactions such as hallucinations, disorientation and suicidal thoughts and actions are very rare.

While the benefits of montelukast continue to outweigh the risks for most patients for the management of asthma, the MHRA says it has continued to receive Yellow Card reports from patients and caregivers since its last Drug Safety Update in 2019.