Neuropsychiatric adverse events are reported in some patients taking leukotriene inhibitors (e.g. montelukast and zileuton)
In 2009, the USA Food and Drug Administration (FDA) reported on an investigation of neuropsychiatric adverse events associated with the leukotriene pathway inhibitors, both the leukotriene receptor antagonists (e.g. montelukast) and the 5-lipoxygenase inhibitor (zileuton) (1). It was concluded that “reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor”. The FDA, therefore, issued the following advice to patients and healthcare professionals:
“Advice to patients and healthcare professionals
- Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.
- Patients should talk with their healthcare providers if these events occur.
- Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.”
July 18, 2017 at 6:19 am
Additional information on adverse reactions to Montelukast (Singulair) include the following, I am unable to add the links but copying and pasting the titles into your browser should come up with the papers etc.:
Psychiatric Disorders and Montelukast in Children: A Disproportionality Analysis of the VigiBase® – 30 Nov 2015
Suicidality Treatment Occurring in Pediatrics – STOP Project – Report of drugs associated with suicidality (Montelukast) – 2013
MOOD AND BEHAVIORAL CHANGES ASSOCIATED WITH MONTELUKAST USAGE IN PEDIATRIC CASES – February 2015
MONTELUKAST-INDUCED ADVERSE DRUG REACTIONS: A REVIEW OF CASE REPORTS IN THE LITERATURE.
September 2014
Montelukast’s Underrecognized Adverse Drug Events – 2 March 2015
Asthma-Suicide Link Confirmed but Indirect – 8 May 2014
Nightmares induced by montelukast in children and adults, 2012
Side effects of the leukotriene receptor antagonists in asthmatic children – Sept 2014
Hepatotoxicity caused by montelukast in a paediatric patient – 2014
Hepatotoxicity caused by montelukast in a paediatric patient. 5 May 2014
Important Elements for the Diagnosis of Drug-Induced Liver Injury