Behavioral changes 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 had two sons on Singular. My three-year old had drastic behavioral changes about a month after starting to take Singulair. He suddenly had severe separation anxiety, was crying and whining all the time, did not want to be alone at all. Normally he is very happy go lucky and we did not see his bright cheerful smile for weeks. I took him to his pediatric doctor and described the behavior and she immediately said to take him off the Singulair. After two weeks, he was back to his normal, happy self. My older son is 5 and has been on Singulair for over a year. I consulted with his allergist right away after my 3-year-old was having trouble. I wanted to take him off the Singulair and he advised against it, because my 5 year old has more serious asthma and allergies. When he first started he had nightmares, and when I mentioned it to a friend whose son is also on Singulair, she said, oh, give it to him in the morning instead of night and that will help with the nightmares. That did help. Yesterday, I decided to take him off of it. It seems like he's always coughing and congested, he complains often of growing pains in his legs that will make him scream and cry and beg for medicine to make the pain go away. He becomes emotionally uncontrollable - i.e. he will have crying jags and when I try to console him or ask him to stop crying he'll say he can't help it and he'll say, "You don't understand, I can't control it." He has also complained of headaches and I wondered how would a 5-year-old even know what a headache is? I feel very naive and am thankful for sites like this because you will not always get this information from your health care providers and also the drug companies. If you are like me, and you've ended up in the emergency room and also calling 911 because your child is having and asthma attack, you be be so afraid you'll give your kids whatever the doctor prescribes and you'll look at it as the lesser of two evils - do you want to be in the emergency room or can you live with the side effects. It has taken me a while to get smart about this. There has to be a better solution out there.

I am so happy to have found this website! I have been taking Yasmin for almost 2 weeks and I am currently waiting for my MD to call to schedule me for an appointment, TODAY!

The first week on Yasmin I experienced slight piercing pain in my chest, but it went away after a day. I did not have any other problems. When week 2 started, I have been experiencing emotional and behavioral changes. I am experiencing depression, lack of motivation, loss of appetite, and fatigue, but I have been having problems sleeping. I am not taking any other medications and my diet and lifestyle have not changed.

These drastic changes in such a short time has me too worried. It seems that I can not function at all.

My son started taking Singulair in Sept 08 when he was 22 months old. I never really gave it to him consistently, since it was just to help with his reoccurring ear infections. I noticed a little change in his behavior, but I thought it was the "terrible two's". I started giving it to him religiously at the beginning of Nov 08. He had his first meltdown on Nov 15. He was totally uncontrollable. I call it the "Exorcist" tantrum. I took him to the ER, but they told me nothing was wrong. (I did tell the ER all of the medications he was taking.) He started waking up in the middle of the night screaming. Each day, he got a little worse. Defiant, hateful, destructive, etc. He still isn't talking much, so he can't tell me what is going on. Christmas and New Year were horrible. We had NO idea that it could cause mood changes (that is putting it mildly). The pediatrician had no idea what could be causing the behavioral changes. He also started biting his fingernails and obsessing over little things, like the strings hanging off of his blanket.

We decided to take him off Singulair after double checking the side effects. We stopped a week ago, and the change is amazing. He is back to my great little boy. I am sooooo glad that we discovered this after only a few months. I cannot imagine living like that for years.

Two days after stopping the Singluair, I found this website: ******

As I read the different cases, I thought that it was exactly like my son. I was convinced it was the medicine. Each day that he gets better and better-like his normal self- I keep getting madder and madder that no one informed me about the possible side effect. The Dr. did not know nor the pharmacist.

Yesterday, I went to the FDA site to complain about the side effects. It just so happens that the FDA released a statement yesterday that they are still investigating the link between suicidality and Singulair.

We need to let everyone know, that if you are using Singulair, please pay attention to their child's behavior. Some people may be just fine, but others (like my son) are not fine.

My 7 year old son has been on Singulair since this spring for a dry hacking cough and allergies. The Singulair worked great clearing up his symptoms. We have not seen any behavioral changes. Our doctor said he only needs to take it during fall and spring when his allergy induced asthma is the worst. Both times that I have taken him off of it for a seasonal reprieve he has developed a VERY PAINFUL STOMACH ACHE. He doesn't vomit, but he rolls around complaining that his tummy hurts. I have seen other posts concerning stomach aches when on the medication, but I am wondering if anyone else has had this experience when they went off of it. Even if he forgot his medication a couple of days, the stomach ache will present.

My three year old daughter was on in as a baby and it was great for her asthma. I stopped it for a year and now she is 3 and has started it again about two weeks. She sleeps at least 12hrs a night and has a nap. This is someone who slept maybe 8hrs a night and never a nap. Actual the sleep is so much its kinda worrying me. I have a hard time even waking her up. What should I do?

My son was on a cocktail of Singulair, Zyrtec, Astellin and Nasonex. Like a miracle, his severe allergies cleared up almost immediately. Months later, behavioral changes started to surface. Extreme irritability, major meltdowns over nothing, problems in school and pulling out his facial hair including eyelashes and eyebrows. We stopped the medication in April and he improved. By mid summer, the hair pulling stopped. When his allergies started up again about 10 days ago, I put him back on the Zyrtec, because I was certain the Singulair was causing most of the problems. Within 3-4 days, the emotional outbursts started, panic attacks that never happened before - he said he couldn't breathe. Now the hair pulling is back. Everyone thinks I want to blame medication for his problems, but I am certain that Zyrtec has something to do with these problems in addition to Singulair. We have taken him off Zyrtec 2 days ago. We have a dr. appointment in 2 days and we will discuss all of this with him. In the meantime, his allergies are back and he is miserable. I would rather him be physically sick than mentally at this point.

My 5 1/2 year old son began taking 4mg Singulair in the p.m. and an inhaler (asmanex) in the a.m. We were still having trouble controlling the asthma and his Sing dose was raised to 5mg. & within 1 week of the increase he began having terrible facial tics and aggravated behavior (defiant, poor listening, easily frustrated and angered) The tics were in the form of opening and closing his mouth, as if you were trying to clear your clogged ears after a plane flight. This caused him much pain in his jaws and facial muscles, so he would tic and then cry as he was in pain. This ramped up his anxiety and it made the ticking worse. He has been off of all asthma medication (cold turkey) for 5 full days. He has episodes where the tics happen for 10 min -1/2 hr, other times during the day it is one here and one there. He does not want to leave the house to do anything, even his favorite activities. Thank god I found this site (and others like it), as I got some answers and some hope. We went to see my cousin this week who is a neurologist and he never heard of the correlation of Singulair and neurologic side effects like these. He said that (hopefully) the medication side effects will cycle through and resolve the ticking and behavioral changes. If not we are probably looking at a Tic Disorder which is in the Tourettes Family.He put my son on a very low dose of Klonopin to mellow out his anxiety and help reduce the tics, but has only been on it for 1 1/2 days and it usually takes a wk or 2 for full absorption and results.I have since sent him and my pediatrician and allergist links to this site and others. I think that I see some improvement in my son, yesterday I thought he did better and my husband thought it was a worse day, I think we have totally lost our perspective and objectivity on this. If anyone out there has a time frame on when they saw significant recovery and positive changes I would love to hear from you. This is a total nightmare and if it is this drug, someone is going to pay. My prayers go out to all who are going thru this.

I am a loving mother of a 5 1/2 year old boy. He has been on Singulair for over 3 years. In this past 3 years my son has suffered in an unspeakable amount. He came down with Rota Virus and was hospitalized at 2. He then came in contact with Pneumonia in the hospital while he was there. They automatically put him on Singulair, Zyrtec, Prednisone, and antibiotics to treat the pneumonia. Since that day, my son has gone though more tests than I have in my entire life. He has had asthma, sinusitis, leg cramping ( to the point he cannot walk for 2 years), IBS, Acid reflux,(they gave him laxatives for a year that made things worse and addicted to them also), stomach pain, constipation and diarrhea back and forth. He also got Erythema Mulitforme TWICE, while on this drug. All of which the doctors said could NOT be caused by Singulair. He has had several Upper GI's and CT scans. Along with Barium enemas, several hundreds of blood tests, and many many pokes and prodded that were not necessary. All since he has been on Singulair. He now has frequent bathroom trips, depression, confusion, and anger outbursts. He also has to go to the restroom every 5 minutes. He has had genital swelling, and many other aches and pains. None of which his "doctor" ever said could be a result of Singulair. I am 100% sure it was!!!! He currently has anxiety and emotional sporadic issues causing problems in school The teachers and counselors say that it is so strange because there is no TRIGGER and the outbursts are completely inconsistent. His preschool teacher and director are sure he has ADHD. Well, we had him tested and he does not have any part of it. He has no learning disability what-so-ever. So that brought me back to square one. He is in a positive loving enviroment. How could he be depressed and want to hurt everyone around him? He cannot sit still. He cries and says he is 'stupid" and "can't think" like the other boys. He has nightmares and cannot sleep alone. He is scared of everyone and everything. So, as I sit here crying, I realized that this has all been a reaction of his "medicine" Singulair. He never should have gone through all of those painful tests, only to prove they couldn't find anything. So many treatments and sound full advice speeches from his doctors. How could they be so naive and selfish in the life of my son?

When I called my pediatrician of 5 years, she told me that " parents that have children with behavioral problems will LOOK for something to blame their problems on." She also said "drug companies only put side effects on their labels to PROTECT the drug companies. (as she laughed at me) They are not always valid". Then she said "if you take you child off of Singulair you will be playing Russian Roulette in his life." Then she said that all children around 5 or 6 go though this emotional time in their lives." She told me that if I take my child off of Singulair that she would no longer be a part of his health regimen for his asthma. She told me to see a Pulmonologist for further treatment.
Who is paying who? This is my son's life???????? I decided to go with my mother-gut instinct and get him off of this medicine. No matter what. He has been a different person since. He is currently going though a lot of side effects and withdrawals (leg pain, insomnia, hic-ups, emotional distress) but every day is getting better. How can the drug companies say that this is a "wonder drug?" There are more reported side effected patients then clinical studied patients! How can a "medication" that stimulates the brain not be connected to other problems? This "medication" interferes with the bio synthesis and action of LTs and has been marketed as NOVEL medication against asthma and allergic rhinitis. Who the hell is playing God here??? The pocket books of Merck or our over PAID "doctors?" Who pays the price? Our children? Or us. Thank god I found this before it was too late. I would not be able to withstand the pain of losing my son due to their lack of scientific evidence. They are lucky I am one of the smart ones. I will not settle for less than Justice for the drug companies and their paid "doctors?" You all end up in the same place. HELL

There are 18 million people on this drug. Most of them are children. Please save a life if not your own child's life. Thank You

After reading all the horror stories on here, me and my husband soon began to realize that we were having a lot of the side effects listed here and not listed on my son's actual Singulair prescription. The side effects my son had were behavioral changes, irrational behavior, inattentiveness, not able to stay on task or stay still -- in fact he broke his arm twice being so hyper, yelling, screaming and just plain mean.

We took our son off of Singulair as a trial for a few days. Immediately we began to notice differences in his behavior. He wasn't as agitated and quick to yell or get angry. (He's only 5 years old). He actually would be listening when we would speak to him. He would sit calmy and read books and the one huge thing he would do was look at us and smile. He even said to my husband once, "I love you Daddy," which just brought tears to our eyes. I never realized what a Singulair fog he was in and what it did to him. Here we were pretty close to getting him evaluated for ADHD or even Aspergers. So now we're in the same boat as others that are searching for other asthma meds to give my son. Right now we have gone back to Pulmicort, Xopenex, Nasonex and Allegra. I'm so glad I read this forum because I was desperately searching for answers for my sons behavioral issues. Oh, by the way he was on Singulair for 1-1/2 years.

I am finally writing after reading these posts since the end of April. That is when I took my 11 year old son off singulair, in an act of desperation. He has been on singulair on and off for about five years for seasonal allergies. He started again in mid-March so it could get into his system, before the allergies started. Immediately thereafter his behavior changed. He was arguing on a daily basis. He would hit, kick or trip me when he was angry. He was starting to destroy things in anger. He seemed to be fueled by anger. It was affecting the whole family. He was starting fights with his younger brother, my husband's heart was palpitating and I was crying every day. I heard about Singulair side effects and looked it up. I saw that it caused behavioral changes and out of desperation, took him off, not knowing what to expect. We had three days of total peace, then on the fourth day another outburst. Then my son told me he had taken a singulair the night before. That was it. I threw every pill in the garbage. He no longers acts like that. It's been almost two months so I am convinced it was the Singulair. By the way, he always complained of headaches, stomach aches and would scream in his sleep. Who knew - it was the singulair all along.

I took my son off Singular a month ago, some slight improvements with the sleep and behavior problems. I voiced my concerns with my doctor twice now he looks at me like Im crazy and then he goes on the PC and says he cant find any of these side affects im talking about. My son was an appointment to see an allergist specialist.

I already posted about my son's behavioral changes while on the drug from the time he was 4-7. He is now 9 years old and has been back to "normal now for 18 months. BUT- we recently had his immune system checked though a blood test and he does not have sufficient immunity for ANY viruses. My 6 year old could fight 8 out of the 14, but my son who was on Singulair for almost 4 years has a severely depleted immune system. And from what I have read, could clearly be attributed to the drug. BUYER BEWARE~!

I have taken adderall xr 30mg once a day for 4 years and have noticed many different emotional levels and behavioral changes. At only 20 i am starting to become concerned with my mental state as of now and in the future. I have experimented with the drug and found that i can take 8 30mg pills at once and survive it, not recommended at all.

A couple of years ago I tried Singulair due to problems with oral yeast infections from my inhaler. I'm a athletic, health conscious 46 year old woman with a high-burn hypoglycemic metabolism, and often have unusual and extreme reactions to food and medications. I hallucinate on Diet Coke, for example. I waited until the weekend to try Singulair just in case I reacted, and it was a good thing I did. I slept about 10 hours in three days, and when I could sleep I had bizarre dreams. I felt like an ADHD woman having a manic episode! My boyfriend noticed behavioral changes right away, and fortunately he did all the driving that weekend! I stopped the drug on Sunday, and was barely able to sit up at work by Monday afternoon. The next weekend I broke the pills into quarters, but had the same problems even with only a fourth of the dose. Once all the drug was out of my system, which didn't take long, I was fine. I went back to my Claritin and Pulmacort Turbuhaler, and I've been fine ever since. I'm both surprised and not to find Singulair causes similar reactions in others. I thought it was just my strange metabolism, but apparently not. This is a sad, cold comfort way to find out I'm not as freakish as I thought. My condolences and best wishes to everyone dealing with children and family members on this drug and/or going through withdrawal.
P.S. I never drink soft drinks anymore, or eat or drink anything with artificial sweeteners, either.

Behavioral changes started when my son was 3 years old and on Singulair, 4mg chewables. He became more angry, irritable, and even stated a few times that he wished he were dead. He has had trouble concentrating and has frequent nightmares.

Our son is nearly six and has been on Singulair since he was 2 y/o. We put is bad behavior down to the "Terrible Two's". He has always displayed signs of poor concentration, impulsive behavior, hyper and the list goes on. Last December his PED proscribed Bactrim for a resp problem and it was just last weekend where we hit breaking point. His behavior has become aggressive along with all of the other bad behavior to the point we have been called for meetings with his new school to have a Physical assessment done.
I researched Bactrim last weekend and it was described as poison which we took him off right away and, it was pure luck i stumbled across this website to find that Singulair may be the EVIL after all.

We took him off both medications 4 days ago and we are praying we see behavioral changes soon....Already i have noticed he is more settled and relaxed while watching TV etc.

Can anyone tell me how long it takes for the medication to leave their system?

My daughter is 5 years old and has been on singulair for 1 week. i have already noticed a dramatic change in her behavior. she has become irritable, mean, nasty, and emotional. she has had me in tears on a daily basis. she has turned into a monster. we will be calling the doctor in the morning!

Our normally mild-mannered 7-year-old son has only been on Singulair for a few days, and we noticed immediate behavioral changes including acting out, aggressive behavior, and he even went so far as to hit another child with a baseball bat at baseball practice last night! Because we had also experienced behavioral side effects with Zyrtec (aggressiveness, etc.), we were particularly in tune with the possiblity that sudden changes of this type might be attributable to the medications. We had thought that switching him to the Singulair would help with the allergies and NOT have the behavioral side effects that we had experienced with the Zyrtec, but found instead that it was even worse! I think we're going to stay off all drugs and just buy extra kleenex for allergies!

This is the worst medication for children. My 7 year old son was on it for one month and his personality slowly changed to the point that I wondered who the @#@! he was! He got angry very easily over everything, he growled at people, he developed anxiety about going to school (he had to be literally pulled off of me), he was never happy, he had nightmares and the list goes on! I stayed awake at night wondering what happened to my sweet, loving, easy-going little guy. Fortunately I put 2 and 2 together in a relatively short time. He got none of the second bottle I got refilled. Within 2 days he was better. Within a week I have my son back. This medicine is horrible and should not be prescribed to children. I don't know what ingredient causes the behavioral changes but pediatricians should at least tell parents to look out for them.

My son has been taking advair 250/50 for 19 months now. He was said to have exercise induced asthma and allergies. But since he has been on it we have noticed behavioral changes, moodiness, extremely emotional, headaches and leg pains.

Could this be advair? Doctors say no but I don't know what else to think. Afraid to stop the medication. Don't know what to do.

I've only been taking synthroid for a little over 2 months and not only has my husband noticed behavioral changes with me but I feel them as well. If I didn't know what depression felt like, I would say that would be the problem, however; it's a lot more than that. I've felt "sad", as though my heart were breaking and then I get angry and have the "I don't care" attitude. Mood swings galore which is very unlike me. I'm naturally a very outgoing and friendly person who has turned to the irate, don't bother me person who likes to be alone. Though these changes have taken place, I feel they may just be temporary which is why I will remain on the med. It's truly a pain in the neck to experience such changes and not be able to so to speak "control" them on your own, but in the long run, if it means being healthier and losing the weight that needs to be lost (on me), then for me, it's worth it. Thank God my husband understands all this!!!

I cannot believe that it took me so long to figure out. My 3 yo daughter has been on singulair for the last 6 months and the behavior changes have been terrible. She never wants to goto sleep, wakes up in the middle of the night, fights me for everything, throwing temper tantrums, demanding, screaming, wide awake at the crack of dawn. I took her off singulair last week and now all of a sudden she goes right to bed and I find myself waking her up in the morning. I am amazed at the behavioral changes. Being a first time mom I never thought it was the meds, I thought it was just normal behavior. I only noticed it after I took her off of them. I thought wow, I have a completely different child, and thank God I took her off it. I will never put her back on it and I suggust that you reconsider giving your child Singulair.

Wow, this is very imformative...I am both shocked and alarmed that they would torture children with this horrible medication. My 12 month old has been on this medication for 1 week, he too has had red stools I figured it was probably a side effect but, I found it very strange that he has been very aggressive, clingy, and throwing temper tantrums, which he never does, he's usually very happy no matter what. I decided to do some research and see if I was the only one who had noticed behavioral changes with this medication. Nonetheless, I just threw the bottle in the garbage where it belongs, this crap should be banned our babies shouldn't have to suffer like this.