FDA’s Responsibility
According to FDA Regulation 21 CFR 201.56(a)(2), prescription drug labeling must be updated when new information becomes available that causes the labeling to become inaccurate, false, or misleading. 
 
New Information Acknowledged by FDA
At a joint committee meeting on September 27, 2019 to discuss the safety signals for neuropsychiatric side effects associated with the widely prescribed asthma/allergy medication, Singulair (montelukast), the FDA acknowledged new scientific information that is not reflected in the current drug labeling (i.e. Prescription Information). https://www.fda.gov/advisory-committees/pediatric-advisory-committee/2019-meeting-materials-pediatric-advisory-committee 

Animal studies indicating the following were cited in the FDA Briefing Document Section 1.4.4 and meeting transcripts pages 111-114:

1. Montelukast’s distribution across the blood-brain barrier is substantial, not minimal as indicated in the Prescribing Information.
2. Montelukast does have structural and functional effects on the central nervous system, not only the airways as indicated in the Prescribing Information.
3. Montelukast’s effects to the central nervous system are mediated through the GPR17 receptor, not the cysteinyl leukotriene type 1 receptor as indicated in the Prescribing Information. Note, GPR17 is recognized as a regulator of cells of the central nervous system with evidence linking their disruption across most psychiatric conditions. The FDA acknowledged this is a possible mechanism for the neuropsychiatric events observed during montelukast treatment.  

This new information served as a foundation for the clinical trials currently being conducted in humans for use of montelukast in treating Alzheimer’s disease.  Read that line again: a drug that has been marketed and prescribed as a medication that acts only on the airways is now being tested for its action on the brain.  Keep in mind, this medication is approved for use in children as young as 6 months of age.

The Significance of the FDA’s Acknowledgment
It is crucial that the FDA takes urgent action to directly convey this evidence-based science, using the strongest methods available, to the medical community. This information will allow practitioners to understand that montelukast acts directly on cells in the brain, not just the respiratory system, which has been a long-standing perception for the past 20 years. Without this understanding, the medical community will fail to recognize:

1. the potential mechanism for the neuropsychiatric adverse events reported by thousands of montelukast consumers;
2. the possibility of a withdrawal syndrome similar to that associated with other drugs that act on the central nervous system;
3. the possibility that the effects on the brain may be potentially irreversible.

Call for Action
Your support of this petition calls upon the FDA to adhere to the aforementioned regulation and take the following actions to convey the new scientific information:  

• Modify the specific sections in montelukast’s current prescription drug labeling to reflect the new scientific information;
• Highlight the information at the top of the drug labeling in a boxed warning;
• Send correspondence directly to health organizations including mental health associations; 
• Implement a Risk Evaluation and Mitigation Strategy program that requires a prescriber certification requirement and patient acknowledgment forms. 

Help hold the FDA accountable to ensure the medical community and general public have access to current, accurate information about their prescription medications. Sign the petition today!
 
For families in need of support please join the “Montelukast (Singulair) Side Effects Support and Discussion Group” on Facebook.