Accolate symptoms and conditions

From the FDA's "Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)"

6/12/2009

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.

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.

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I have been reading all of these posts and have another question. I hope that someone can help. My daughter, 8 years old, has been on Singulair since she was 4. She is normally a very happy girl with a wonderful disposition. For the last year or so, she has been having trouble getting herself to sleep at night. She says that she hears things in her head such as ringing or "noises". A few hours before she knows it's bedtime, she cries and when we ask her why she's crying, she can't give us a reason. We initially thought that she was crying for no reason because she didn't want to go to sleep. I remember reading about the side effects of Singulair causing mood swings, etc., but her's are not violent mood swings. Just very emotional and has a hard time coming down from the "episode". I'm at a loss...I have not talked to her doctor yet about it, but have told her that we will make an appointment this week to discuss it with him. My husband suggested that maybe it sounded like she was having a panic attack or anxiety attack. I hate to label her as that at such a young age. My mind now goes back to the side effects of Singulair and maybe this is to blame. Any help or suggestions would be greatly appreciated. Thank you! Concerned Mom

I'm a 30 year old male, and I've been on Singulair for eight years now to treat chronic asthma. Shortly after I started, there was a noticeable change in my mood and behavior. What I noticed included sadness, thoughts of death, anxiety, and fatigue. I knew that there was something wrong, but just chalked it up to changing life experiences. I was always heavily involved in organized sports (little league through college), but abruptly stopped after college. I thought that the moodiness (or depression) came on because I wasn't as active anymore. Correlation maybe? I don't know. But I do suspect that Singulair is the culprit. I would like to get off for a while, but I literally cannot breathe without it. Does anyone know of any comparable alternatives to Singulair that won't bring on these type of side effects? Thanks all for sharing. Blessings!

From Canada:

Leukotriene receptor antagonists: suspected adverse reactions

The cysteinyl leukotrienes are inflammatory mediators that bind to cysteinyl leukotriene receptors found in the human airway and cause a number of airway actions including bronchoconstriction, mucous secretion, vascular permeability and eosinophil recruitment.1 Zafirlukast (Accolate®) and montelukast sodium (Singulair®), marketed in Canada since November 1997 and August 1998 respectively, are competitive cysteinyl leukotriene receptor antagonists. Zafirlukast is indicated for the prophylaxis and chronic treatment of asthma in patients 12 years of age and older.2 Montelukast is indicated for the prophylaxis and chronic treatment of asthma, the treatment of asthma in ASA-sensitive patients and the prevention of exercise-induced bronchoconstriction in pediatric patients 6-14 years of age and adults 15 years of age and older.1

As of June 1, 1999, the CADRMP has received 41 reports of suspected adverse drug reactions associated with the use of zafirlukast and 22 associated with the use of montelukast. This article will discuss a serious and rare adverse reaction associated with the use of these agents, drug-drug interactions and unexpected adverse reactions that have been reported to the CADRMP.

http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v9n4_e.html

Conditions are discussed in the article.

Given the latest news on drugs Singulair eii of the same family Accolate and Zyflo Cr, I wanted to ask if there is someone who takes Zyflo Cr and had disturbances similar to those of Singulair?

I have headaches at night, difficulty getting to sleep (I think Singulair raises blood pressure for a few hours after taking it), and general tiredness during the day with Singulair. I would suggest Accolate. A similar drug, and I find few problems. No trouble sleeping, no headaches. Not quite as good for allergic asthma as Singulair, but I prefer it due to fewer side effects.

Okay- A friend just emailed this site to me, my son is 4 and has been taking Singulair for about 2 years. He has seasonal allergies which seem to be year round, asthma and food allergies. He is on Singulair and Allegra daily, this in it self freaks me out. What I have noticed for at least the past year is that when he is running around or moving a lot he hold his right side and says he has a pain in it, we now call it a "stitch". it happens not from strenuous activity, our doctor just says its growing pains, that doesn't make sense. something is bothering him it happens with somewhat frequency. I am really thinking about his behavior, it seems to me he can change on a dime. from happy to very angry, outbursts and then right back to sweet, yes this could describe any 4 year old, but not any 4 year old is on Singulair. I remember saying to him where is my sweet boy? I feel like that might have been when we started the meds, i am so used to his behavior now that it seems almost normal but there was a time he acted differently. and i do remember saying that.... was it when he went on Singulair???

I've been taking Singulair for about a year and a half. Last summer I mentioned horrible leg and foot cramps to my pulmonary doctor who I see twice a year for asthma. They claimed that they had never heard of cramps from this drug. I tried everything from going off from my estrogen to drinking extra o.j. and eating more bananas. Nothing changed; but without the singulair I have severe burning in my upper back all the time. In November I returned for my doctor visit and was told that they had done some research on the leg and foot cramps and that it is considered a side effect. I was changed to Accolate which is not a drug my insurance company accepts. The leg cramps went away but the burning in my back was so severe from the asthma that I returned to using Singulair. I now have such awful leg and foot cramps that I spend several times a night walking my house. I've also been told that the pain and burning in my back should not be associated with the asthma and the doctor cannot explain why the singulair helps with this but it does and I'm afraid to stop. I'm very torn between the cramps and back burning.

Theresa
Michigan

I just switched to Singulair from Accolate, simply because my insurance company prefers Singular and the co-pays are significantly different.

Has anyone who has taken both drugs noticed any difference between the two?

Also, and I realize I might be asking in the wrong place, but are the moodiness symptoms described here for Singulair common for Accolate as well?

Thanks,
LDK