Testimony Before the FDA’s Pediatric Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Montelukast

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In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Pediatric Advisory Committee and Drug Safety and Risk Management Committee, Public Citizen urged the committees to recommend that the FDA strengthen warnings and alert healthcare providers about the use of montelukast for the treatment of asthma and the risk of neuropsychiatric events because this risk is inadequately communicated by healthcare providers/prescribers and patients remain unaware of the risk of these adverse events.

See Public Citizen’s other work on montelukast.