Asthma Drug Linked to Neuropsychiatric Adverse Events

A retrospective study of montelukast, an asthma and allergy treatment for children and adults, has found a positive association between the drug and neuropsychiatric adverse events including depression, aggression and nightmares.

Using the Netherlands Pharmacovigilance Center Lareb and the WHO Global database, VigiBase, researchers retrospectively assessed all adverse drug reactions with montelukast. Montelukast is a selective leukotriene receptor antagonist indicated for the prophylaxis and chronic treatment of asthma; for the acute prevention of exercise-induced bronchoconstriction, and for the relief of symptoms of allergic rhinitis.

The results showed that overall depression was the most commonly reported adverse event in the VigiBase group (Odds Ratio [OR] 6.93; 95% CI: 27.5–32.2) while headaches were the most frequent adverse event reported for the Dutch database (OR, 2.26; 95% CI: 1.61–3.19). 

When the VigiBase data was adjusted to include only children, aggression was found to be the most reported adverse event (OR, 29.77; 95% CI: 27.5–32.2). Allergic granulomatous angiitis was reported in 8 patients in the Dutch database and 563 patients in VigiBase. Nightmares were often reported in all age groups but were especially frequent among children.  

“Because of the high incidence of neuropsychiatric symptoms – especially nightmares – after using montelukast in both children and adults, the clinician should discuss the possibility of these adverse events with the patient and parents,” said Meindina Haarman, lead author of the study.

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