To the Editor:
On behalf of Merck & Co., Inc., Kenilworth, NJ, USA (“MSD”), this letter is in response to the article by Benard et al. [1].
We noticed that the abstract section of the referenced manuscript contains the following statement:“Although montelukast is generally well tolerated, postmarketing studies have reported serious neuropsychiatric adverse drug reactions (ADRs) leading to a United States Food and Drug Administration black box warning.”
MSD, which manufacturers Singulair® (montelukast sodium), would like the Editor to take note that this statement is incorrect. The US Product Information for Singulair does not contain a Black Box warning and, thus, it is inaccurate to state that the US Food and Drug Administration (FDA) required the inclusion of a Black Box warning related to serious neuropsychiatric drug adverse reactions. A link to the US Product Information for Singulair is provided for reference [2].
Please note that MSD updated the US Product Information for Singulair to contain safety information related to neuropsychiatric events in the Warnings and Precautions section (5.4 Neuropsychiatric Events) and Adverse Reactions section (6.2 Post-Marketing Experience).
Disclosures
Supplementary Material
E. Urdaneta ERJ-01984-2017_Urdaneta
Footnotes
Conflict of interest: Disclosures can be found alongside this article at erj.ersjournals.com
- Received September 28, 2017.
- Accepted September 30, 2017.
- Copyright ©ERS 2017