From the authors:
We thank Eduardo Urdaneta, from Merck & Co., Inc., for his correspondence regarding our paper [1] and appreciate the opportunity to reply to his concern.
In 2008, the US Food and Drug Administration (FDA) was investigating a possible association between the use of Singulair and behaviour/mood changes, suicidality (suicidal thinking and behaviour) and suicide. It issued a warning about an increased risk of psychiatric events associated with montelukast. This warning was not a black box warning, however; and we respectfully request that these words be removed from the abstract [2].
In 2012, the label warning was maintained and worded as follows:“Neuropsychiatric events have been reported with SINGULAIR. Instruct patients to be alert for neuropsychiatric events. Evaluate the risks and benefits of continuing treatment with SINGULAIR if such events occur.”
In 2014, the FDA analysed post-marketing cases in the paediatric population and maintained the warnings and precautions in the labelled safety issues for prescribers.“Patients and prescribers should be alert for neuropsychiatric events. Patients should be instructed to notify their prescriber if these changes occur. Prescribers should carefully evaluate the risks and benefits of continuing treatment with montelukast sodium if such events occur.”
The latest 2016 label maintains this warning [3]:“Neuropsychiatric events have been reported with SINGULAIR. Instruct patients to be alert for neuropsychiatric events. Evaluate the risks and benefits of continuing treatment with SINGULAIR if such events occur.”
Given the high rate of neuropsychiatric events we observed in our paediatric cohort study, we strongly encourage all physicians to pay attention to the current FDA warning for prescribers and patients to be alert for the possibility of neuropsychiatric events. In addition, it is our opinion that, before contemplating montelukast, physicians should consider, and discuss with patients and parents, the risk of neuropsychiatric events with montelukast.
Disclosures
Footnotes
Conflict of interest: Disclosures can be found alongside this article at erj.ersjournals.com
- Received October 16, 2017.
- Accepted October 17, 2017.
- Copyright ©ERS 2017