Montelukast: Risk Of Neuropsychiatric Reactions

Montelukast is the leukotriene receptor antagonist. It works by blocking the action of leukotriene D4 in the lungs resulting in decreased inflammation and relaxation of smooth muscle. It is used for a number of conditions including asthma, exercise induced bronchospasm, allergic rhinitis, and urticaria. It is mainly used as a complementary therapy in adults in addition to inhaled corticosteroids, if inhaled steroids alone do not bring the desired effect.

European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recently completed a periodic review of the available safety data in association with the orally active montelukast and neuropsychiatric reactions including nightmares, insomnia, somnambulism, anxiety, agitation aggressive behaviour or hostility, depression and psychomotor hyperactivity are known to occur and also considered cases of dysphemia (a speech disorder characterized especially by stammering or stuttering and usually having a psychological basis) which have been reported in association with montelukast. The majority of these cases involved the paediatric population, especially young children less than 5 years of age. Based on review of this data, an association between montelukast and dysphemia as well as other closely related speech disorders cannot be excluded.


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