ConexiantFDA: Montelukast May Impact Brain Functioning

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Recent FDA research reveals montelukast (Singulair) demonstrates significant binding to multiple brain receptors involved in psychiatric functioning. This finding adds scientific context to thousands of reported neuropsychiatric adverse events and supports the FDA’s 2020 decision to add a black box warning for mental health risks.

Key Points:

• Laboratory tests confirm montelukast’s significant binding to brain receptors critical for mood, impulse control, cognition, and sleep regulation
• FDA researchers discovered the drug accumulates in brain regions associated with psychiatric effects, contradicting earlier claims of “minimal” brain distribution
• The drug’s behavior patterns mirror those of known neuropsychiatric medications like risperidone
• By 2019, the FDA’s adverse event database recorded 82 suicides linked to Singulair and its generics since 1998, including 31 cases in patients aged 19 or younger
• The FDA added a black box warning in 2020 highlighting serious mental health risks, including suicidal thinking and actions
• Current findings are preliminary and ongoing; the FDA does not plan label updates based on this data

“He was on that medication for just days, literally just days. It completely changed the trajectory of our lives.”
– Robert England, whose 22-year-old son Nick killed himself in 2017 less than 2 weeks after starting montelukast

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