MHRA investigates risks associated with montelukast after concerns over neuropsychiatric reactions
Review will cover new data on risks, lack of awareness of side effects among patients, carers, & clinicians, and whether further regulatory action is needed. It comes after families of children on the drug reported serious side effects, including aggression & suicidal behaviour.
Source:
British Medical Journal
SPS commentary:
In 2019, the MHRA had advised prescribers to be alert for neuropsychiatric reactions in patients taking montelukast and to carefully consider the benefits and risks of continuing treatment if they occur. In 2020 the US FDA added a black box warning about “serious mental health side effects” to montelukast.
The Pharmaceutical Journal reports that Yellow Card data published by the MHRA show 143 reports of psychiatric disorders associated with the drug in 2023, the highest ever number reported in a year.