Update Prescribing Information for Montelukast (Singulair) to Include Impact on the Brain

In 2016 you signed my petition requesting increased warnings for asthma and allergy medication Montelukast (Singulair) due to the severe and potentially life threatening neuropsychiatric side effects. We need your help again!

Laura Marotta has just released a new petition asking the US FDA to update the Prescribing Information to include the acknowledged impacts that Montelukast has on the brain. 

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).

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

- Montelukast’s distribution across the blood-brain barrier is substantial, not minimal as indicated in the Prescribing Information.

- Montelukast does have structural and functional effects on the central nervous system, not only the airways as indicated in the Prescribing Information.

- 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.  

No matter where you live in the world, please sign and share this petition to let the US FDA know that this information requires updating. We hope that action in the US will flow into other countries.

Thank you so much for your support, it means a lot to affected families and the courageous advocates that are working hard for positive change and increased safety around the use of this medication.

PLEASE SIGN and SHARE. 

https://www.change.org/p/fda-we-demand-accurate-drug-labeling-for-singulair-montelukast