The possibility of neuropsychiatric reactions associated with montelukast is already known and documented in product information. However, a recent EU review identified cases in which such symptoms have caused significant hindrance and suffering to patients before being recognised as possible adverse reactions.
Following very rare reports of cases of dysphemia and obsessive-compulsive symptoms, the EU review endorsed the inclusion of these in the product information as very rare potential neuropsychiatric adverse events. For cases where information was provided, the events resolved on stopping treatment in most instances.
Between 2014 and 2018, the MHRA received 219 reports of suspected adverse neuropsychiatric reactions linked to montelukast via the Yellow Card Scheme, during which time there were approximately 14 million prescriptions for the drug. The most frequently reported reactions, in adults, adolescents and children, include nightmares, depression, insomnia, aggression, anxiety and abnormal behaviour or changes in behaviour.
Prescribers have also been advised to raise awareness among patients and caregivers by advising them to read the list of neuropsychiatric reactions included in the patient information leaflet and to seek medical advice should these occur.
Prescribers are reminded to report suspected adverse drug reactions to the Yellow Card Scheme.