A big thank you to Jenna of Parents United for Pharmaceutical Safety and Accountability for the FDA update on the negative side effects that children on Singulair experienced (read Asthma, Singulair and Depression for our story).
Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)
Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling).
Montelukast is used to treat asthma, and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose), and to prevent exercise-induced asthma. Zafirlukast and zileuton are used to treat asthma.
The 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.
This information reflects FDA’s current analysis of available data concerning this drug.
To report any serious adverse events associated with the use of this drug, please contact the FDA MedWatch program using the contact information at the bottom of this web page.
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.
In April 2009, FDA completed its review of neuropsychiatric events, (mood and behavioral changes) possibly related to drugs that act through the leukotriene pathway (montelukast, zafirlukast, zileuton). As part of its review, FDA reviewed post-marketing reports and also requested that manufacturers submit all available clinical trial data for these products.
The post-market reports of patients on these medications included cases of neuropsychiatric events. Some reports included clinical details consistent with a drug-induced effect. In the clinical trial data submitted by manufacturers, neuropsychiatric events were not commonly observed. However, the available data were limited because the trials were not designed to look for neuropsychiatric events. Sleep disorders (primarily insomnia) were reported more frequently with all three products compared to placebo.
My daughter’s depression resolved within a week of stopping the Singulair. However, her anxiety is still through the roof. She is afraid of the smoke detectors and will not walk underneath them. This means that she won’t walk anywhere in the house by herself. She cannot play in her room like a typical 5.5 year old child. Her anxiety is disheartening and I only hope that it gets better with time.