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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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!
My son started Singulair for extreme allergies which always triggered winter asthma. The Singulair worked like a charm and he was on it for quite a while. Last year he started having severe full-on panic attacks at 8 yrs. old. Most were associated with school but this was place where he had never been anxious before. It was so severe, we placed him in therapy and had to remove him from school and home tutor for part of the year. Eventually, we placed him on Zoloft and worked to integrate him back into all his social activities. We had taken him off all of his medications when it started at the recommendation of our pediatrician. After a year of normalcy, we put him back on the Singulair for allergies. We immediately saw the panic and emotional reactions begin again. Only on the drug for 2-3 weeks, we took him off thinking there might be a link. He was his normal self again within a week or so of going off the medication. We still deal with the anxiety now which I feel is now a lingering effect of the medication. I feel like once your brain has experienced a panic attack, it is hard to retrain it not to react that way. I am so upset at the thought that the medication may have caused this in my son and that we can do nothing now to reverse it.
I too have been experiencing many of the same symptoms with my 10 year old son using singulair. I can’t express enough the emotions going through me as I’m reading all the posts on-line by parents with similar experiences. My son has been on singulair for years. I’ll be checking with his allergist and pediatrician to determine exactly how long it’s been. Anger, depression, crying, trouble sleeping, outbursts, major behavioral issues. I’ve spoken with his two doctors and a therapist. I did stop giving him the medication several month’s ago, his symptoms got even worse so I put him back on. It seemed to me he was going through a withdrawal. I spoke to his doctor who dismissed it with a “huh.” Nice. She just said I could try taking him off of it again. My fear now is: are the withdrawals real and what can I do about that? Also, how much damage has been done? I’m just so sick about this. It’s been so traumatic.
My son was 3 yrs old when he first started useing singulair. He is now 6 and has anger issues, nightmares, sleep walks, mood swings, lies alot, gets very mad when he gets into trouble,fights with his siblings alot, disobeys, wakes up with tingeling in his arm, and depression. He was such a sweet little boy who loved to make people laugh. Now he can be sweet one minute and blink my eye and he’s a totally different child. He will litteraly disobey me and get into trouble then run crying he’s sorry. We had him tested for ADHD and the doctors said he was a normal 5 yr old at the time. He had his tonssils removed at age 3 and thats when he developed asthma. I never put two and two together thinking it was the singulair until he started having nightmares and told me,” Mom i feel like someone is going to stab me when i’m asleep” that’s when i started looking this up. That is some thing I would never expect my 6 yr old to say to me. He is now off the singulair and we are going to try some other means of meds to help him but not first without me researching them. I do not suggest anyone putting there children on singulair. I hate talking about how bad my son is when its the meds doing this to him i just wish i knew this all before, that way i could of prevented it from even happening. I thank everyone for there comments that I have read it helped with my decision on taking him off this terrible medication.
My 7 yr. old daughter was on Singulair for seasonal allergies/ chronic ear infections several years ago as a 3/4 year old and it worked wonderfully with no noticeable side effects to us. She’s been off of it for 3 or more years. This spring we have not been able to get her allergies under control. She was miserable and nothing over the counter seemed to work. I took her to our pediatrician who has prescribed Singulair again. We had a good experience before so I started her on it. She has been taking it only 5 days and we notice extreme differences in her mood, personality and attitude. She’s fatigued, cranky, weepy and apparently lacks focus in school. FIVE days!?? If your child is taking this STOP now!! I remember reading about the side effects this 1st time she was on it, but since we had no issues with it I thought it would be fine again. WRONG! This is a scary drug for anyone and especially children. I regret giving to her.
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