🏥 Healthcare Professionals:
Be vigilant for neuropsychiatric symptoms in all patients (children, adolescents, adults) using montelukast.
Discontinue montelukast if neuropsychiatric symptoms worsen or new symptoms appear.
Strengthened warnings in patient materials, highlighted with a black box for emphasis.
Report all suspected adverse reactions via the Yellow Card scheme.
🧠 Reported Neuropsychiatric Symptoms:
Sleep disorders, hallucinations, anxiety, depression.
Behavioral and mood changes.
🌐 Advice for Patients and Caregivers:
Be aware of potential psychiatric side effects.
Immediately seek medical advice if neuropsychiatric symptoms occur.
Inform friends and family about your montelukast use; they can help notice changes.
📚 Updated Patient Information:
Patient Information Leaflet now includes detailed warnings about psychiatric side effects.
📉 Incidence of Reactions:
Sleep disturbances, depression, agitation: up to 1 in 100.
Attention/memory disturbances: up to 1 in 1,000.
Rare cases of hallucinations and suicidal thoughts: up to 1 in 10,000.
🛑 Important Updates:
Since 1998, over 44 million prescriptions in the UK, with significant reports of neuropsychiatric reactions.
Neuropsychiatric warning included in product literature since 2008, with updates in 2019.
Continued reporting to Yellow Card scheme is crucial to monitor these risks.
📅 Published by MHRA on 29 April 2024
References:
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