RSS Feed Print
New FDA Black Box Warning: Montelukast (Singulair)
Jo C.
Posted: Saturday, March 7, 2020 11:38 AM
Joined: 12/9/2011
Posts: 13330

 No judgment here, but because some are looking at Montelukast as a treatment for dementia, this is a timely bit of information:

 Edited:   This Post is information only . . . . please do NOT stop prescribed medications without FIRST consulting with your physician.   This link does not imply that all will develop mentioned side effects.  Repeat:  Consult with your physician first.



Posted: Sunday, March 8, 2020 2:35 PM
Joined: 2/17/2019
Posts: 380

While potential side effects can be scary, and they are in every way valid.  Potential side effects are just that, potential.

I think we need to look at the seriousness of the condition being treated vs the side effects.

In cases where the thing being fought is Allergies, those with allergies can choose whether they want to take that risk, or try another medication.

When it comes to fighting Alzheimer's, there isn't a lot of choice out there. If Montelukast is improving cognition and staving off dementia, that seems a lot more serious to me that allergies.

There are a lot of options in the pipeline, but we have this now.  Until they find a drug that can address the cornocopia of alzheimer symptoms at the source, this disease will need to be attacked from several angles. 

Lets not ignore a drug that works, out of fear, lets use what we have, CAREFULLY.


Posted: Sunday, March 8, 2020 3:44 PM
Joined: 2/26/2016
Posts: 273

I read about the black box warning a few days ago. I am a little surprised that the FDA has gone that far. I have read several articles about children taking this drug for asthma and allergies and parents reporting severe neurological side affects. I think children have rapidly developing brains and are more likely to show serious side affects than adults.


Black box warnings should be taken seriously. However we should consider what is the proper response to the warning. If it were a black box warning for increased risk for heart attack, stroke, cancer, liver or kidney failure, or other life threatening disease, we would see that it would be difficult to evaluate the risk. It would require lots of lab tests and much uncertainty. Maybe it would not be worth the risk and uncertainty of taking that drug.


However in the case of montelukast, it is warnings about possible agitation, depression, sleeping problems and suicidal thoughts, and lab tests would not likely be required and risks could evaluated by patient and doctor while taking the drug, and a decision could be made about whether or not to continue.


We should be getting some results from the Emory University trial by the end of the year, including its effectiveness and side affects. I myself believe montelukast will prove effective because I have been taking it for four years with no bad side effects and I am completely back to normal. 


If the results are positive, we can weight the benefits of an effective treatment with whatever side affects may come up. I still think montelukast has proved to be a very safe drug for adults for long term use.