The Montelukast Controversy has grown due to serious neuropsychiatric side effects linked to the asthma and allergy drug. While Montelukast is effective as anti-histaminic, legal action and medical scrutiny have intensified. Let's explore the scientific and legal aspects. 🧵👇
Mechanism of Action
Montelukast is a leukotriene receptor antagonist (LTRA). It blocks cysteinyl leukotriene receptor 1 (CysLT1) in the lungs, effective for Mx of Asthma. However, it does cross the blood-brain barrier (BBB) leading to potential neuropsychiatric symptoms.
Montelukast is a leukotriene receptor antagonist (LTRA). It blocks cysteinyl leukotriene receptor 1 (CysLT1) in the lungs, effective for Mx of Asthma. However, it does cross the blood-brain barrier (BBB) leading to potential neuropsychiatric symptoms.
Neuropsychiatric Side Effects
In 2019, the FDA issued a Black Box Warning for Montelukast due to reports of severe depression, anxiety, aggression, and suicidal ideation. The warning discouraged its use in patients with mild allergic rhinitis where risks outweigh benefits.
In 2019, the FDA issued a Black Box Warning for Montelukast due to reports of severe depression, anxiety, aggression, and suicidal ideation. The warning discouraged its use in patients with mild allergic rhinitis where risks outweigh benefits.
Proposed Mechanisms of CNS Effects
Preclinical studies suggest leukotrienes play a role in neuroinflammation, with CysLT1 receptors in the hippocampus and amygdala, regions involved in emotional regulation. Its interaction with them explain the psychiatric side effects.
Preclinical studies suggest leukotrienes play a role in neuroinflammation, with CysLT1 receptors in the hippocampus and amygdala, regions involved in emotional regulation. Its interaction with them explain the psychiatric side effects.
Epidemiological Data
A 2020 Swedish cohort study of over 20,000 patients found a significant association between Montelukast and neuropsychiatric events in children. The study highlighted a 7X increase in suicidal ideation in pediatric patients with no prior psychiatric history
A 2020 Swedish cohort study of over 20,000 patients found a significant association between Montelukast and neuropsychiatric events in children. The study highlighted a 7X increase in suicidal ideation in pediatric patients with no prior psychiatric history
Pharmacogenetics & Susceptibility
CYP2C8 gene metabolizes Montelukast. It increases its susceptibility to adverse CNS effects. It aligns with variability in neuropsychiatric reactions among patients, raising the need for personalized approach in prescribing Montelukast.
CYP2C8 gene metabolizes Montelukast. It increases its susceptibility to adverse CNS effects. It aligns with variability in neuropsychiatric reactions among patients, raising the need for personalized approach in prescribing Montelukast.
Severe Asthma & AERD
Montelukast is vital treatment for patients with AERD or corticosteroid-resistant asthma. The challenge for clinicians is balancing its benefits with the risks of neuropsychiatric side effects, especially in pediatric populations
Montelukast is vital treatment for patients with AERD or corticosteroid-resistant asthma. The challenge for clinicians is balancing its benefits with the risks of neuropsychiatric side effects, especially in pediatric populations
Legal Action: Failure to Warn
Merck, the manufacturer of Montelukast, is facing multiple lawsuits alleging its failure to adequately warn patients and doctors about the neuropsychiatric risks. It had internal data but did not take action until the FDA’s Black Box Warning.
Merck, the manufacturer of Montelukast, is facing multiple lawsuits alleging its failure to adequately warn patients and doctors about the neuropsychiatric risks. It had internal data but did not take action until the FDA’s Black Box Warning.
The Shearer Case:
The family of 15-year-old Nicholas Shearer sued Merck after Nicholas died by suicide after starting Montelukast. The lawsuit claims that Merck failed to provide warnings about the risk of suicidal ideation, even though it had the evidence of such risks.
The family of 15-year-old Nicholas Shearer sued Merck after Nicholas died by suicide after starting Montelukast. The lawsuit claims that Merck failed to provide warnings about the risk of suicidal ideation, even though it had the evidence of such risks.
Hassenkamp Case:
Joseph Hassenkamp, a 17-year-old developed severe depression and anxiety after starting Montelukast. On discontinuing the drug, Joseph’s symptoms improved. The family’s lawsuit argues that clearer warnings could have prevented this psychiatric harm.
Joseph Hassenkamp, a 17-year-old developed severe depression and anxiety after starting Montelukast. On discontinuing the drug, Joseph’s symptoms improved. The family’s lawsuit argues that clearer warnings could have prevented this psychiatric harm.
Montelukast lawsuits are consolidating into multi-district litigation (MDL), streamlining cases for faster resolution. The outcomes of these legal battles may lead to changes in prescribing guidelines and stronger warnings for Montelukast, particularly in children & adolescents.
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