A big thank you to Jenna of Parents United for Pharmaceutical Safety and Accountability for the FDA update on the negative side effects that children on Singulair experienced (read Asthma, Singulair and Depression for our story).
Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)
6/12/2009
Updated information
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.
This information reflects FDA’s current analysis of available data concerning this drug.
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.
Advice to patients and healthcare professionals
* Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.
* Patients should talk with their healthcare providers if these events occur.
* Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.Background
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.
My daughter’s depression resolved within a week of stopping the Singulair. However, her anxiety is still through the roof. She is afraid of the smoke detectors and will not walk underneath them. This means that she won’t walk anywhere in the house by herself. She cannot play in her room like a typical 5.5 year old child. Her anxiety is disheartening and I only hope that it gets better with time.
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Related posts:
- FDA Safety Alert Regarding Xolair, an Asthma Medication
- Update on the Singulair/Depression Issue
- Asthma, Singulair and Depression
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{ 2 comments… read them below or add one }
Thanks for getting the word about regarding the Parents for Safety website http://www.parentsforsafety.org/17601/10794.html
I think many of us are seeing many side effects subsided very quickly after going off of Singulair. A year later, my son is still experiencing aggression when overhwelmed socially. I have no idea if this is connected to Singulair and there is no way to prove it one way or the other. But many other parents are finding 1) they get their sweet kids back after years of aggressive, inflexible behavior very quickly after coming off of Singulair. 2) they often see some lingering side effects that aren’t nearly as bad as they once were but still cause problems at school, home, with friends, etc related to anxiety, aggression and the like 3) many or most of these symptoms are similar to many other pathologies, disorders like AD/HD, Aspergers, Anxiety, Depression, etc. There’s no way to know whether it’s one of those or long-term side effects from Singulair, and once the symptoms present and stay, what other choices are there. There’s no research, no proof. It’s maddening this is such a frequently prescribed med to our young children!
I just found out this weekend about all the dangerous side effects of Singulair and I am desperate!!!
My daughter was prescribed singulair by her doctor for being constantly sick allergy/sinus/asthma and took it for 3 months last year, she changed her behavior dramatically and I couldn’t put my finger on it, thought it was terrible 2s, I was having a baby, my sweet little girl went from being a happy camper to a maniac…crying, hyperactive, tantrums, not sleeping, etc…I took her to so many doctors and couldn’t accept that until the doctor prescribed again and as I gave to her 7 months later, she was much better ( she was of for 7 months ) I thought she was out growing…I gave it again and 3 days later boom, I have another child at home. I cannot believe there is a drug out there doing all this to children and families and the FDA allows it. I read 722 complaints of parents all with pretty much the same symptoms, all devastated like me. This has to stop!