Neuropsychiatric events with Singulair

[shay]

Hi everybody,
I am mom to a 15 year old daughter with CF. She has not had an easy path with her CF so far although I'm certain some have had a lot worse. But at 15 she has a port (usually on IV antibiotics 2-6 weeks/year) and has CFRD. She also had a gtube from age 5-14. Even with all those challenges however, she has remained a positive, optimistic person and has always been super compliant with her CF meds and treatments.
But it has been a tough year. She started high school in September.Right before that her CF doc had put her on prednisone then medrol. Shestarted feeling really depressed, moody, not sleeping, etc. Every side effect in the book. She even beganhaving some weird dream like"terrors" at night. Like someone or something was after her. Not unusual when on steroids from what I understand.
But recently, she has had these night "terrors" again. Or more accurately, she has REALIZED she's been having them for a long time. Frighting stuff. Spiders or scary people coming after her. No wonder she was always exhausted in the mornings and found it impossible to get to school. Then I came across the information below about Singulair. Has anyone else experienced anything like this? We have taken her off the Singulair and she seemed at first to be better. But lately she is still bothered by these terror type of events at night. I'm thinking that she was on prednisone and then singulair for so long and suffering with these terrors for so long that they are not just going to go away overnight when we stop the meds. Does anyone else have any experience with this sort of event?

<strong>6/12/2009</strong>
<strong>Updated information</strong>
Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling).
Montelukast is used to treat asthma, and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose), and to prevent exercise-induced asthma. Zafirlukast and zileuton are used to treat asthma.
The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.
<em>This information reflects FDA’s current analysis of available data concerning this drug.</em>
<em>To report any serious adverse events associated with the use of this drug, please contact the FDA MedWatch program using the contact information at the bottom of this web page.</em>
<div align="center"><hr align="center" size="2" width="100%" />
<strong>Advice to patients and healthcare professionals</strong>
<ul>
<li>Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.</li>
<li>Patients should talk with their healthcare providers if these events occur.</li>
<li>Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.</li>
</ul>
<strong>Background</strong>
In April 2009, FDA completed its review of neuropsychiatric events, (mood and behavioral changes) possibly related to drugs that act through the leukotriene pathway (montelukast, zafirlukast, zileuton). As part of its review, FDA reviewed post-marketing reports and also requested that manufacturers submit all available clinical trial data for these products.
The post-market reports of patients on these medications included cases of neuropsychiatric events. Some reports included clinical details consistent with a drug-induced effect. In the clinical trial data submitted by manufacturers, neuropsychiatric events were not commonly observed. However, the available data were limited because the trials were not designed to look for neuropsychiatric events. Sleep disorders (primarily insomnia) were reported more frequently with all three products compared to placebo.

 

[jbrandyn]

Well now I am glad my insurance denied singulair and I stayed on advair.
Have you tried other long acting bronchio-dilators like Flovent or Advair? I don't know what all is in Singulair, but when I am on prednisone i get night terrors so there could be other meds having an effect coupled with the singulair.

If the night terrors are interfering with her ability to thrive then it might be a good idea to see a licensed clinical psychologist, if for no reason other than help dealing with CF and adolescence, but I would chance a bet that it would help with the terrors and overall quality of life regardless of their cause.

Best wishes.

 

[shay]

Thanks for the reply jbrandyn. She absolutely is seeing a shrink. I was just shocked when I got online and saw all the horror stories from patients and parents about this drug. I wanted to see if any other CFers had a similar experience.

 

[concernedmom]

All of my children and DH have been on singulair at various times ranging from a few months to several years each. We didn't notice any neuropsychiatric events at the time. One DS is ADHD with mild adjustment disorder and the other DS has generalized anxiety disorder (GAD), ADHD, and depression secondary to the ADHD/GAD. Singulair didn't cause an increase in anxiety or depression in either of them. Our main issue with the drug was that we didn't really see that it helped (not to say it didn't, but we didn't notice an improvement in symptoms.)

In retrospect, it is possible that DD's nightmares/night terrors may have been exacerbated by the med. She was on it from age 2-6 and has used it off an on since. DD had frequent nightmares, night terrors, and sleepwalking from the age of 2-6. She still has them on the odd occasion; however, the frequency and intensity has gradually decreased over the years. Given that she was at the typical age for nightmares/terrors, we never considered that the singulair could be a contributing factor.

 

[Mistyjo]

I tried taking singulair with Advair this past spring and it made me feel odd so I stopped taking it. I didn't feel right on it and it didn't help anyways.

 

[Melissa75]

I had issues with lucid dreaming from my early teens untill about 22 yrs, toward the latter half of that time, terrifying dreams and sleep paralysis-- where you wake up but cant move and in my case feel terror/negativity. I was on no meds then.
and yet, I've been on singulair now for yrs w no problems.

My point is singulair may do this to your daughter. Or the issues may be unrelated. Youll have to decide that empirically. But many people are fine on it, and though many people seem to write on those drug reactions sites, they are the minority and some may be making anecdotal connections. (Not all by all means.)

Fwiw when i am on an extended quinolone abs regimen, i have some pretty scart sleep disturbance.

 

[shay]

I absolutely believe that these adverse reactions are not typical. I do believe though, that in my daughter's case, the singulair is exacerbating a problem that was set into motion with the prednisone and helped along with the usual teenage angst. A perfect storm. It DID seem that from my research the age groups that were most affected by the singulair were the pre adolescent and teenage groups. What do you all think?

 

[LittleLab4CF]

Thanks to shay and the great posts. Added to the usual CF meds, I have lived long enough to need medications for typically for the aged. I know, if you all should be so lucky. I too take singulair, and have for years. In the last year, I have been becomming hypomanic. This is a subtle difference from my typical ADHD I have had all my life, but something has pushed me well beyond hyperactivity. I have an upcoming doctors appointment, and Singulair just went to the top of my list. In the meantime I caught the message and tomorrow I am naking an appointment with a counselor.

 

[shay]

I am thinking that there must have been substantial evidence for the FDA to have reviewed this type of side effect and to have listed them in the warnings for Singulair. I don't think it's a common side effect, but i think it must be happening. And probably more than it is being reported. It took us quite a while to tease out the this drug might be a player in these "night terror" events.

 

[Melissa75]

I think you're right to look into it, and when you note that often meds affect developing brains differently (accutane is the one that immediately comes to mind).

 

[MargaritaChic]

I am surprised that your doctor did not inform you of this side effect before putting your child on the drug. Especially knowing her history.
Our daughter is 4 and the doctor told us of this potential effect before putting her on the drug. She also let us know that the percene of people that experience this side effect is very small, but that it is something to watch out for.

 

[shay]

I would LOVE to blame the doctor but it was kind of tricky. She had been on Singulair on and off for years. Never really seemed to have a problem. It was just this last couple of years that we have noticed that she is very sensitive to these chemicals. Things she was able to tolerate before she no longer can. The last run of prednisone was a nightmare. Could have something to do with her body changing with adolescence. So she actually STARTED Singulair BEFORE 2009 when the FDA came out with these new warnings. Throw in an illness, a bout of prednisone and some typical teenage angst and it was really hard to see that the Singulair was playing into this too. A very murky puddle...