Singulair and fda

My son who is 5 years old was on Singulair for 5months. He turned into a total different child. He developed extreme OCD, anxiety, excessive crying, scared at night, and irritability. After researching I found out it was the Singulair causing his symptoms, so I immediately took him off. After just a couple of days his mood lightened. It took a few weeks for the anxiety and OCD to go away, but it did thank God! Although, the main debilitating symptoms went away he still after 5 months is irritable and takes offense to anything and everything. It is like every time I talk to him I say something wrong and it annoys him or makes him mad. Our relationship is completely different now. It is like we are not as close. This was not my son before Singulair. I am heart broken. I read peoples post and most say after taking their children off Singulair all the symptoms went away and their children are back to normal. I feel there is 20% still missing after 5months of being off Singulair. My son is not 100%. I am beginning to feel like he may never be 100%. I feel like it causes some permanent damage. Does anyone else feel the same? Or have a similar situation? Or have still experienced recovery past 5months? I would love to hear your story. THANKS!!

My son is 12 and has been taking Singulair for the last ten months...he has been getting moody and upset for no good reason over the last 3 months and I put it down to "hormones" starting to kick in. He has now gone to feeling very sad and has even told me last night that he has thought about killing himself several times and feels he can't go on, or cope and feels lost and lonely or unwanted and in the way. He is confused and does not understand what is happening to him. I have just realized it may be the Singulair and will be taking him off it immediately. I'm hoping it is this as if it isn't I feel totally helpless as to how to help my child. Please say a prayer for him. He used to be happy go lucky.

I am totally upset by reading the posts here. my son is just now 8 months old. he was put on singulair when he was just 6 months old. at first it seemed to be working...for maybe 2 weeks...then everything went crazy. he was started out on it when his pediatrician stated that he had asthma and apparently was on a very high dosage of it. they started him on 10 mg of the oral granules. before taking it he was a very happy baby, even with him being so young i never had any problems with him crying excessively or being massively irritated. since he started on the medication he has had massive irritability spells, constant fussing and crying and cant seem to fall asleep at night let alone stay asleep very long. i had taken him to the emergency room on christmas eve because a new problem showed up. he now was having a massive hard time breathing, he had a persistant cough, congestion in his chest and was almost always gasping for air. the staff at the hospital were in disbelief when they were informed that his pediatrician had put him on singulair at such a young age and at such a high dosage. i am now in the process of obtaining a lawyer and filing a lawsuit against the pediatrician for medical malpractice. this drug is very dangerous for anyone especially children. i would suggest anyone else having these problems with their child and this drug do the same. it can apparently cause long term lung damage, pulmonary disorders and even death. my son has been off of the medication since christmas eve and has already done a massive turn around. he sleeps well and through the night again, his breathing has improved and his cough is almost gone. they did say in the E.R that he has congestion in his chest due to the singulair but it should clear up over time with the help of zyrtec. please help make a stand and protect our children from the dangers our own pediatricians present to them.

My sixteen year old son, five year old son and three year old son are all on singulair for allergies. My three year old actually has asthma. They have been on the med for about a month. The singulair has been working just great so far as symptoms are concerned.
My five year old has complained of hearing people call him by name...people that were not me, my husband or his brothers. He says he doesnt know who it is but it's not us. Several times a day he says, "Mommy did you call me?" "Someone called me." He has also told me and my husband about a few bad dreams that were very vivid. Needless to day, after the second time my son complained of hearing voices, we no longer have given any of the boys the medication.AGJ Chesterfield, VA

When I was using Singulair I had trouble sleeping, then I had trouble waking, even after 10 hours of sleep! I had racing heart rates, headaches often, my blood pressure was high, which it never was before, gained weight, felt like I was often on the verge of tears, mean aggressive and plain old nasty which in unlike me. Would have the craziest dreams or nightmares I ever had. I've been off for several months (10) I've been like the old me for quite awhile now. I had surgery in 2006 and had the usual testing done everything was normal. I am getting ready to have some surgery so my dr. ordered some test, an ekg which came back abnormal, it was explained to me that it was like my heartbeats didn't have a strong beat, maybe a heart attack or something. I never felt or knew anything about this. I am wondering if the singulair did something to my heart. I was on singulair for about 18 months. If it weren't for the ekg I would have never known this problem exsisted. I have no symptoms of any heart problems. I am a 52 year old woman who eats great and exercises daily (since I was in my 20's) . Anybody else have any similar reactions?

We have a 5 year old daughter who has been on singulair for about 2 - 3 years. She went on singulair due to coughing asthma. We were soo happy about how well the medication worked, it took about three months, but wow, she finally got over her coughing and was living a more active life. I actually was soo impressed with it, I remember mentioning it and promoting it to some of our daughters friends' parents with children in similar situations....wow do I ever feel awful. Anyway, our daughter came down with a terrible flu a few weeks ago and although she didn't seem feverish, had not one, but 2 night terrors, something that we have been worried about and comforting her with for a couple of years. These 2 threw the 2 of us over the edge this time....we thought we had to get her to a psychologist.....she was terrified, and although we were holding her and comforting her, she was still screaming for us, and there was NOTHING we could do this time....we were doubting ourselves and the environments she was exposed to......what could have happened in her life to make her have such awful dreams??? It was about a 1/2 hour later when my husband asked about the possible side effects of the singulair.....I ran and grabbed the pamphlet, of course this is the first time that I actually sat down and read it, which I should have done some time ago....anyway it was then that I discovered how many issues weren't normal that everyone just kept ensuring us was fine. We had been questioning ADHD for some time, and had actually had it on our list to discuss with her teacher as she was sooo hyper on a regular basis...at the age of 5 she still couldn't sit through a movie at a movie theater, as much as she loved going, she couldn't sit through it....anyway, the only thing that made it difficult to think she could have ADHD was she was such a great learner. She was very eager to learn and loved learning and teaching things. But when giving her instructions or asking her to listen, she'd be so jumpy. She complained of severe leg pains which we chalked up to growing pains...poor thing! Her temper tantrums were out of this world.....she is a child that is soo full of love, but when she was in tantrum mode, she was soo destructive and she would feel soooooo awful for her actions, it was like she couldn't control herself. We just feel awful that we couldn't help her and we didn't realize that what she was experiencing was not so much disobedience, but an imbalance due to the medication. We have since taken her off the singulair, we took her off of it immediately following reading the pamphlet. We found that she was VERY emotional for about 3 days, then she pretty well recovered. She has since become a normally active 5 year old, she is soo good, and has not experienced any night terrors, complained of leg pains, and absolutely no tantrums. Oooh how we love her so much.

My 4 year old son started taking singulair when he was two. I don't think I picked up on his behavior change right away b/c I thought that he was just entering the "terrible two's". But over time, his allergist added on Nasonex (I know the docs say that it doesn't cause side-effects b/c it's a nasal spray, but I don't buy that...it's a steroid, plain and simple) and more recently zyrtec was added on for his hives. Well, the zyrtec was the straw that broke the camel's back. I mean, he has been a real "handful" since the singulair, but after zyrtec was added 5 months ago - let's just say he was completely out of my control. His meltdowns were so bad that I couldn't go ANYWHERE with him. I either got a sitter or just didn't go anywhere. He became aggressive, defiant, emotional, unhappy. And to top it off he started to have serious "autistic-like" self-stimulatory behaviors (grinding teeth, squinting eyes shut, flapping his hands, punching himself...). At this point my life had become a complete nightmare, and my poor 10 month old son was getting NO attention b/c my 4 year old was so out of control and aggressive. I was afraid for the baby's safety...oh, I could go on all night. This medication has impacted my marriage, my finances, my sanity. Shortly after he started Singulair I had to go on an antidepressant b/c it too so much out of me just to be his mommy. Anyway, a week ago I had him scheduled for a psych evaluation (thought for sure we were going to walk away with either autism or bipolar diagnosis), but two days before I decided to look up the meds he is on and BINGO! All of these posts sound like what we have been going through. I stopped all of his meds that night, cold-turkey, and he has been the most pleasant little boy I have ever met!! My husband and I have fallen in love with him over the past week - we had no idea he was such a sweet child.

Now, while I'm ecstatic that we have found the answer to our nightmare, I also feel SO STINKIN' ANGRY! We lost out on 2 years with our sweet boy, there were times when we raised our voices at him when he just couldn't help himself - he was suffering inside!! When I went to talk to the allergist about my findings this past week, he said, "well, maybe he just had a good day. I'd like to see what happens if he goes off all his meds for a week". Well, there you have it, he has been off for one week and he's an absolute angel. He has an amazing heart and is so caring!!!

Singulair is awful (and so is zyrtec). Please don't give this drug to your children. Research other alternatives (I am giving my son Nordic Naturals Fish Oil, Culturelle probiotics, vitamin c, and am changing his diet - increased magnesium and decreased dairy. I came up with this after hours of research...).

There is a woman on this site whose daughter committed suicide after 3 years on Singulair. This is no joke and the FDA needs to get with it.

BTW, I used to date a Singulair rep (I knew there was something I didn't like about that guy:)

My 7-1/2-year-old son was on Singulair for 5 months for asthma and possible allergies. He had been on medication for ADHD for almost a year at that point and had been doing well with it. Singulair made him into a monster. He could not be reasoned with and was constantly overreacting to everything. Just asking him to put on his shoes caused explosive reactions, even to the point of threatening us (his parents) with bodily harm if he did not get his way. We unexpectedly stayed the night out of town and did not give him his Singulair for a few days and started noticing that he was much more rational, calm, and more like his old self. I had heard of the depression risk with Singulair and googled about it this morning and was floored by the amount of children with these type reactions. It is now listed as an allergy for my son and I will never give it to him again.

I was encourage when i read the post of the lady a few posts down,who picked up her prescription and it was covered in stickers telling her of post market side effects,a long time coming yes ,but it is happening none the less.Several articles on merck have noted flat Singulair sales,due to safety concerns,the word is getting out slowly but surely.I know we have been frustrated with how slow it is all happening,but it is happening.One of our hospitals here in cleveland now will list a doctors affiliation with a pharma company,important news for us that know what the implications of that could mean.We have had an education in the medical system,which quite frankly i found shocking,i don't think any of us will every fill a prescription again with out research,we have learned ,we are not the same,we must continue to change a system that is broken ,the dollar must be secondary to the health of all of us.I again urge all that still have issues to file a report with the fda,Keep on fighting

I posted serveral weeks ago about taking my 5 1/2 yr old off singulair. He has done great as far as the asthma, no problems what so ever. The main reason I took him off was due to his behavior. Very moody, hyper, aggitates easily and so on. Well, after the 2nd week, he was like a NEW child...very calm and behaving in school. Well, he has pretty much regressed back to the behavior before taking him off this med. He has now been off of it for 5 weeks. His teacher asked me last week, if I had to put him back on this med, because he was getting back to his old ways.
He is currently going the an evaluation for ADHD. I have stuggled with the fact that my son may suffer from this and have tried almost everything to avoid medicating him...I was really hoping this was the culprit to his behavior..He had been on singulair for over 4yrs...Is it just going to take longer to see the full effect of NO SINGULAIR???

I have an 8y.o. daughter that has been on Singulair for about 3 years now. Since she started taking singulair she has been absolutely miserable! She cries at everything, is very moody, has leg pains, wont leave my side and is tired ALL the time. She has circle under her eyes, she looks like she hasn't slept a wink in days! She has been off her Singulair for about 5 days now and she is a totally different person. She has been "happy-go-lucky" and full of herself, she has even woke up happy (which hasn't happened in I dont know how long). She was put on Singulair by our Doctor b/c she had Pnemonia two times in a row. She has Allergies and Asthma and for the past 3 years has been on: Singulair (4mg), albuterol, flovent, Zyrtec, and Flonase. That is just too much for a little girl to be on. She hardly eats at all, gets headaches. I just see such a difference when she is not on it but, what will she take in place of this? My husband also takes Singulair (he is miserable all the time), he doesnt sleep at night and is always tired. Anyone have alternative to this drug?

My 3 year old is on 5mg of singular daily for her constant allergy issues and has had NO trouble at all with it. Her personality has not changed.. she's happy, outgoing, friendly and MUCH better than she was before she started the medication. Prior to starting she was constantly dripping from her nose, she had both ears filled with fluid, had bags under her eyes and was tired and grumpy all the time, due to allergies we could not get under control with other over the counter or prescription meds. Since being on Singulair she's been 100% better than she was. I'm sad to hear that others are having so much trouble with it, but I can say that I am happy my little girl is feeling better.

I am shocked and outraged at the "NEW" list of side effects that were attached to my newly refilled Singulair prescription. I am an adult and have been taking this medication for 3 years. I also know that I have not been happy in three years and every day I feel more and more hopeless and withdrawn. I have little interest in leaving my house, being with other people or anything else. Everything in life seems like an overwhelming task for me. I am filled with ideas about how to 'get away-far away'. I am a decent person, a wife and a mother of 3, but lately I would have done anything to be able to get a divorce and run. I have hated myself for these thoughts, which makes it all worse. I'm always reminding myself that these are people that I'm supposed to love! I ran out of my Singulair right before Thanksgiving and kept putting off refilling it, quite frankly, because I just didn't have the 'energy' to go to the store and pick it up. I did pick it up 2 days ago and that's when I noticed the new labels all over the bottle and was shocked when I read the description of the side effects. It was if they had been written about me. I have not taken any more of it and have now been off for more than a week and I feel like a human being again.

I was surprised to hear that Merc, the maker of singulair update their side effects 4 times in one year to include depression, anxiety, suicide, and suicidal thoughts. It was prescribed to me cos of my allergies and asthma. I never really took singulair on a daily basis because it made me feel so tired and out of it. So i would only take it when my allergies were very very bad, like having a bad sneezing fit or nose would be runny non stop which would be at least 1 to 2 times a month. My asthma wasn't really that bad, i would get it when my allergies would act up like i mentioned before. When the fires in California were going on my asthma started acting up because of all the ash in the air. I was having asthma attacks every day. Since singulair works great for asthma i started to take it everyday and noticed my asthma went away. The first couple days were fine..and after two weeks i started noticing i was becoming anxious and irritable. Also depression sunk in...So i wondered what was causing it. I wasn't going trhough any major life changes. So i looked up singuliar side effects and noticed the four new side effects that i mentioned above...I stopped taking the pills to see what would happen and i felt emotionally better but the asthma came back..id rather suck on my inhaler then be anxious and depressed.

My ADOPTED son almost 6 and was already on Singulair when he came to live with us at age 20mos.
After finding this site just over 2 weeks ago, I took him off on this stuff. Well, after about a week, things were so good that it was scary. His behavior improved so much, that everyone said he doesn't act like Jacob. I said, yes he does, we just didn't know him before going on this med.
He is currently going thru ADHD evaluation and I advised the therapist that I took him off this drug and he was like a new child. Her comment was "did we cure him"? Well, after her one on one with him, she commented, I don't know whats wrong, but he is extremely HYPER and then all hell broke loose on the way home. But, he has been fine since.
I am praying that I don't have to medicate him for ADHD, I am just not ready for that and have been fighting it for a while and then after reading all the side effects on this site, it described my child to a tee. He is in Kindergarten and is doing great academically and the therapist was a bit surprised by that with how hyer he is.
Please tell me with how long my son has been on this drug, that it's going take more than a couple of weeks. He is not near as hyper to us as he was before. Maybe he just got excited about all the toys in her office. He can also be very defiant, that is whole other issue we are dealing with. He does way better for his Dad than Me, so now if he doesn't want to listen to me, he Dad intervenes. I am hoping he will get it, that he can't be disrespectful to his Mom or he will have his Dad to deal with.
Thanks for listening and please pray that his behavior will continue to improve over the next few weeks with the absence of Singulair.

My son is 3 and has been on Singulair since around springtime (I think... I've lost count). Anyway, during this summer we noticed his behavior had just gone straight to hell. At first I was attributing it to the wonderful world of the three year old, but it was just getting ridiculous. He was having countless meltdowns, screaming bloody murder (I mean SCREAMING to the point of going hoarse), hitting, punching, slamming, banging, crying hysterically for ridiculous reasons, yelling out during the night, and showing OCD behaviors. I was fearing that he might have ADHD/OCD until my husband stumbled upon this website. I remember hearing stories about teenagers having horrible side effects from singulair, but didn't think it was affecting my son at 3. As I read the entries on this website I felt like they were talking about my son.

I am taking him off of it to see what happens, but now I'm nervous that his asthma will flare. He's had quite a few asthma episodes since the fall allergy season has started. I suppose he'll need to go for awhile to get everything out of his system to see if the behavior changes, and then I hope to find a new preventative. We have Pulmicort and Xopenex and an inhaler ready!

*UPDATE* Well, it hasn't quite been two weeks since I've taken James off of Singulair and - I am not kidding you - his behavior improved the FIRST day. I want anyone who reads this to know that I am not an "alarmist", I DON'T freak out over everything I read, I do a lot of research (kind of obsessive myself :), so please understand that I am not one to usually write things like this...I mean, I pushed my allergist to give it to him in the first place! There are plenty of kids out there that are fine on Singulair, but some are not. I didn't make the connection to the Singulair since the average three year old is irrational and unpredictable anyway, but I KNEW something wasn't right. It wasn't just tantrums and whatever, his overall personality had done a 180. In the last two weeks my son has returned. He still, of course, has three year old moments, but he is back to the caring, loving, curious, excited, social, happy kid I had last year. One of the worst things we were seeing two weeks ago was bedtime behavior. BAD OCD behaviors - everything in his room had to be PERFECT. The curtains couldn't have a peek of light shining through, there could be nothing on the floor, everything had to be in order. He would obsess about things (creatures) coming into his room, when we would say goodnight and close the door he would scream and cry like someone was stabbing him and was petrified. The FIRST night that we stopped the Singulair he laid his head on his pillow, said goodnight and went to sleep. Please keep an eye out for personality changes in your kids.
*November update* it's been almost two months since we took James off Singulair and we haven't seen ONE BIT of the horrible behavior that we had w/ the Singulair! Normal "three-year-old moments", but no return of the "devil child", no OCD, nighttime freak-outs, violence, or any of it.

Oh my gosh. I am on this website because I googled "behavior issues with Singulair" Both of my children are on Singulair. One from as young as 5 months old. Both Pulmonologist, allergist and Internal med Ped. insisted that it was a safe drug. They aren't living with it. My 7 year old has taken it consistently for 5 years and recently upped is having behavior, aggression, insomnia and constant reports back from the teacher on his behavior. We had him psychologically evaluated and they found nothing uncommon to his age. All his issues are described in almost everyone of these side effect threads. I am just afraid to take him off and feel the blame if something serious happens. I am calling tomorrow for possible alternatives.

So happy to find this site. I never noticed My son never had an eye tick until last month, ironically we started giving him Singular on a daily basis about the same time. My son just turned two and is has also been waking up screaming 3 times every night. Have others reported this same problem...also he is on Pulmicort too, have you read that it is linked to Glaucoma and Cataracts? Do you think that this could be causing the tick? Please HELP! I want a parent's opinion before bringing this up to the doctor...they are so quick to jump to more drugs it makes me sick! Thank you! Any other children with eye "ticks" like really quick consecutive blinks?

my 6yr old daughter was put on singulair at the age of 4 she had a reaction to nuts and had the allergy testing she was put on singulair and claritin and nasacort .(so she has been on the medication now for 14 months) about 3and 1/2 weeks ago she quit eating we had her to the dr several times they said it was all in her head that she could eat if she wanted to.she was then put in the hospital for 4 days they did the scope down the stomach found nothing i took her off all her meds because i didn't want her taking them with no food in her. she came home from the hospital and i put her back on the meds as the doctor requested and within 2 days she was crying non stop hitting me and telling me that she wanted to kill herself and everyone around her.she was putting her fists in everyines face and was very angry.she would cry and tell us that she didn't know why she was so angry.we took her back off of the meds because we were treating her for the stomach acid from not eating and within 4 days she was like a new kid.she is now eating ..happy ..and doing good in school..this is the 3rd time this yr on this med that she has quit eating we were told that it was all in her head .after reading everyones comments on here i called her doctor today and he said it could be the medication but they would have to put her back on it to check and i refused.no more singulair or clairitin for my children

October 22, 1998 I had resp. failure (with intubation). My new pulmonary doctor put me on Singulair 10 mg once a day, a few weeks after. Within time, I started to have numbing and tingling in my face, arms, and legs. March of 1999 the symptoms worsened and started causing pressure in my face, arms, and legs, and anxiety started to kick in. I was told I had neuropathy and to take mobic. Symptoms getting worse, and went to a rheumatologist in June 1999, and he was suspect of singulair. The doctor thought that what I was experiencing was due to the singulair. He (the rheumatologist) discussed this with the pulmonary doctor and the pulmonary doctor did not believe this to be the case. Not forgetting, in March of 1999, I had a ct of the sinus area, and low and behold 1/3 of the cavity was and probably still is full of polyps.

As time went on, symptoms getting worse, and not one bloody doctor could figure out why I was feeling this way. In addition, at times, I was put on steroids for my asthma (not including my inhalers).

Two years ago, my body went into shock, leaving my left side very different than my right side. Affecting: my head, my face, my eye, my ear, my esophogus, my lungs, my arm, my leg.

I have been depressed and anxious not knowing what the heck was going on with me.

Recently ruled out thyroid, and lupus, and possibly ms.

Last weekend, I reviewed the letter from the rheumatologist (dated 1999) and the ct report from March 1999 (regarding the sinus/ polyps) and made copies to present to a pulmonary doctor that I have recently been seeing.

This past Monday the 10th, I had my appt with him. He knew of my situation from the last few visits (in addition, I had met him this past March for a pulmonary rehab program, and thought he seemed to be knowledgeable and compassionate). While waiting for him to enter the exam room, he had read those reports before entering.

The doctor looked at my hands (red as a beet and swollen) and said "You have Churg-Strauss Syndrome, and get off the singulair."

I had done my homework from a few weeks ago, where I looked up untreated polyps.
Untreated polyps, can turn into vasculitis. There are many types of vasculitis, to include Churg-Strauss Syndrome.

I then cross ref CSS and singulair, and low and behold, BINGO!

I have been suffering for ten years, physically and emotionally because of this drug!

There is also recent updates from the fda (fda.gov) regarding singulair, of which most recently includes anxiety and depression.

I suggest before taking singulair, be aware of the side effects. As soon as a side effect comes up, contact your doctor. Also, be aware of existing conditions (like me, sinus problems and asthma) for this could lead to churg-strauss syndrome.

This info is indicated on the actual disclosure (the paper insert that indicates studies, side effects, etc...) not the handout that is given with the drug.

By the way, I am now working with a new rheumatologist in Los Angeles (Cedar-Sinai affiliated) and a new neurologist.

mdklezmer

Hi, All

I normally do not post on websites, however, the issues that I read about in other toddler has me concerned for my grandson as well..

He started to live with us in Georgia three months ago. He was 20 months old. Over Labor Day weekend he developed a severe sinus infection and virus with a fever. Against our better judgment then, we allowed his doctor to prescribe an antibiotic which seem to help him for about two weeks, but her began having excessive mucus and coughing constantly. He had no fever. When we returned to the doctor, they suggested that he use Claritin because he had no infections, but a lot of mucus and drainage. Claritin worked, however, the side effects were he was a little sluggish. The doctor recommended trying Singular. We tried it for three weeks. Over that three weeks, we noticed that his appetite decreased and his aggression level increased where he started a fight with another toddler. He is normally an easy going little boy. He has been very aggressive lately, plus he has had dry coughing and gagging worse than when he was on Claritin. When I read the literature that says this medication causes sinusitis, I immediately decided to discontinue it. He will not be using this medicine again. It may be great for some children, but they really ought to make parents aware of the side effects. They are awful.

I was first given Singulair at the age of 21. At which time, I quit a job in which I have yet (at 28) to match its income. My doctor continued to give me samples as I could not afford the medication. During this time, I was very depressed, contemplated suicide often and was given a serious of antidepressants-non of which helped. For one reason or another, I stopped taking everything. At which time, it seemed I had a new lease on life. I went back to college, finished my degree, and got a job in decorating. My asthma began acting up again, and again I took singulair and again had to be given antidepressants. I wound up quiting that job too and worked a serious of low paying jobs. Again, I quit, and again found the urge to "live" again. I never connected the two, until this past week. I was given singulair again by another doctor on Wednesday. Thursday I had nightmares, Friday I spent the day crying, Saturday night I began to think of leaving my husband (I also did that ALL the other times I took the drug and we've been together 14 years-I love him). Today is Sunday, I normally go to bed around 12 or 1 a.m., but I am making myself stay awake and have all day. This drug has ruined a large part of my life, please, if anyone notices even a little depression with this drug, Stop!!!! It is not in your head, it is this drug!!!!

My son is almost 4 but has been on Singulair since he turned 3. We saw an immediate improvement in his allergies and asthma and thought it was a miracle drug. That is until we started to see our sweet, outgoing little boy change into something we barely recognized. We thought maybe it was just a stage he was going through or something and didn't connect it to the Singulair until his doctor accidentally wrote his refill prescription for 5 mg. instead of 4 mg. After about 2 weeks on the 5 mg. his mood swings increased substantially. He cried for hours everyday at school. He had previous trouble with his emotions at school on the 4 mg. as well. He continued to cry and throw fits at his preschool so often that he was ending up in the principals office. At home, he became clingy and so emotional that he would cry about everything. After doing some research on Singulair, I immediately took him off the drug. Within 1 1/2 weeks off of the drug, my little boy was a different child. I thought maybe I was the only one who had noticed until his teacher came to the car and ask what happened. She said that he didn't even resemble the same child that started school. He is sweet, and calm. He can take discipline without crying and gets praise every day instead of going to the principals office. His trouble sitting still and listening to the teacher are gone and her push for us to have him tested for ADHD has ended. He is now a star student. The only difference is the removal of Singulair from his little body.

Everyone should go to 2004 postings for a reality check. It blows my mind that people were reporting disturbing behaviors/moods in their children in 2004 and we're still talking about it in 2008. Where's the oversight?

My 18 yr old daughter has been on singulair for several years and has complained this week of numbness in her feet and toes. I have told her to stop the drug. Is this a reversible side effect? Does anyone know if there is anything else to do?

I have been making inquires as to how and if the fda will conduct investigations in to permanent damage left from this drug.Although on taking my son off this drug i saw a 90% improvement,i am still missing the final piece,is it that he lost 3 years to this drug or did it do damage that cannot be fixed,we as parents need to know.The FDA responded to my letter,they said if they see a trend in reports from medwatch,it may prompt an investigation .I am asking all who still have missing pieces to file a report.What has happened is a tragedy,we need to explore ever option for continued success for our childrens future.Good Luck to all,Keep Fighting

I notice vivid dreams/night mares the first night. The second day I notice thoughts of running of to very far places. The third night severe chest pains, extreme anxiety, irritability, and thoughts of suicide. Now I have been treated for depression in the past but never attempted suicide. After the third day of singulair i wanted to take a gun to my jugular vain in my neck and pull the trigger. Oh the joy of a panic attack.

I was prescribed singulair for asthma 7 years ago in my late 30's. I experieinced mild side-effects first including vivid dreams/nightmares, insomnia mixd wiht bouts of over-sleeping for work, runny nose, etc.

Then I developed a series of kidney infections, increased irritability, lack of concentration and heart palpitations.

Depression set in, along with the obsession of shotting myself in the head, running away to far away places, and risk-taking behavior.

I became difficult to work with and left a good paying job/career and suffered increasing irrational teenage rebellious behavior that i chalked up to a mid life crisis, until the suicidal idealization and late night insomnia and cutting hateful things into my skin with razor blades set in.

Then I left another job and had no health care. In months my outlook improved and problem-solving reason returned. A year later, with new medical insurance, I renewed my prescription, only to find the bad thoughts and gloom returning.

Within weeks my doctor and pharmacist warned me about the suicidal side-effects of the drug.

Now that my life is a train wreck, who do I sue?

I cant imagine subjecting a child to this medication.

Please seek alternatives and protect your children.

Why does Singulair cause these symptoms? I am going to give my explanation which is only a HYPOTHESIS. This should not be categorized as any thing but an educated guess. This is not backed by scientific research because nobody will do any research that would appear to anger
Merck even if people are suffering in the thousands.

1. The original research that preceded the development of Singulair (montelukast) seemed to focus on the theory that asthma was caused by an unusual immune response to certain pathological stimulus. There are many references to the observation that a high percentage of asthma sufferers are people whose asthma is caused by fungus. Many people suffer from asthma and are told that they are allergic to dust mites. Dust mites can live only because the fungus aspergillus pre-digests the
food source that dust mites can then absorb. Other sources of fungus occur in the home due to dampness or problems with wood rot.

2. The body's immune system fights certain categories of pathogens such as bacteria and fungus by creating nitric oxide which kills them at the site where they try to enter the body. The mast cell is the immune cell that is responsible for the production of nitric oxide. Mast cells are found in the skin, airways, intestines etc. The mast cell is capable of many different types of biochemical functions that are designed to signal other cells or other chemical responses. When the mast cell knows that pathogens
are present and nitric oxide is NOT produced, then it signals other immune cells to be sent to the site of the infection. Thus in the case of asthma, it is known that excessive numbers of eosinophils appear in the airways and these cells create inflammation.

3. Singulair was developed for asthma and later allowed to be prescribed for other reasons. I believe that montelukast probably creates a source of nitric oxide that prevents the mast cell from signalling for other immune cells to arrive at the source of infection. I arrived at that conclusion from studying the chemical structure of montelukast, the chemical structure of the gene cysLT1 receptor, and the chemical structure of the cell wall of fungus which would be what the mast cell uses to determine "what to do in order to kill the fungus."

The researchers who invented montelukast first had to clone the gene-cysLT1 receptor meaning that they had to be able to identify the gene and replicate it. Then by trial and error they had a find a "chemical"
that would bind (connect chemically) to the cysLT1 receptor. The theory would be that montelukast would take the place of the fungus or other pathogen and thus prevent the gene from reacting to produce the
responses that the sick patient with asthma produced. Merck says in the literature that montelukast binds with the cysLT1 receptor in order to prevent the mast cell from signalling the eosinophils to arrive in excessive
numbers that cause inflammation. I believe that montelukast is also causing the production of an amount of nitric oxide that is actually killing the pathogens that are present. For one thing, I would think that it
would be dangerous to incapacitate the immune system in that way without providing a way to kill the pathogens. I don't believe that the asthma response is just allergies to something like dust. Pollen from trees and flowers is loaded with fungus spores.

4. IF, IF, IF, montelukast does actually produce nitric oxide, then it does so by binding with the gene. Any place in the body where a molecule of montelukast encounters the cysLT1 receptor (a gene) then the corresponding molecules of nitric oxide are produced before the liver enzymes break the montelukast molecules up. Nitric oxide is TOXIC and
INFLAMMATORY. So let's look at the symptoms in regard to the location of the cysLT1 receptors. The location of these symptoms would not be places in the body where the mast cells normally encounter fungus or bacteria. The cysLT1 also has other functions in that it communicates with the cysLT2 receptors. Obviously, nitric oxide
should not be produced in these locations because of the signalling effect of nitric oxide on other physiological functions.

a. intestinal pain - the cysLT1 receptors are located in the small intestines
b. leg pain actually caused by vasculitis - cysLT1 receptors are found inside blood vessels- consistent with the fact that montelukast causes
Churg-Strauss
c. some people who didn't have asthma develop asthma - the cysLT1 receptors are in the airways
d. nightmares, depression, neurological damage - when montelukast penetrates the blood brain barrier probably due to unusual conditions of blood pH or electrolyte imbalance then nitric oxide in the brain causes neuron damage and excitoxicity

5. Why do some patients not experience side effects? Probably because genetically they are completely compatible with the model that researchers created when they cloned the cysLT1 receptor gene. I didn't not find any information about whether researchers knew that there are many different variations of this gene.

6. IF, my theory is even close to being correct, then why doesn't Merck do anything about researching these side effects. Maybe because nobody in the company knows how this drug works but the researchers who created it. All of the Merck literature is very vague about any biochemical information.

Again, this is just speculation and hypothesis. I have made an attempt to put this in simplistic language and therefore sacrifice scientific accuracy. But, I think that you will get the point.

SINGULAIR IS VERY DANGEROUS TO PATIENTS WHO EXPERIENCE NEGATIVE SIDE EFFECTS. DOCTORS SHOULD JUST REALIZE THAT
THOSE PATIENTS ARE NOT COMPATIBLE WITH THE MODEL FOR THE DRUG.

I am so thankful I found this site! My 4 year old son who suffers from asthma & allergies was just prescribed Singulair on Tuesday 10/21 along with Pulmcort inhaler & Xyzal.The doctor said to give him these daily for a month due to it being Fall. I do not like the idea of him being on any drug let alone 3 at one time. So today I started to do research on them. I will NOT be giving him the Singulair ever again!! He only had it the past two nights. He only had one pill on Tuesday night and by Wednesday night at his basketball practice he was saying he was tired and laying on the floor...this is so not like him. I believe it probably was from this medicine already having an effect on him. I am glad I found this site before he started to have these horrible symptoms that so many innocent children have had. I am going to call his Doctor and ask for something else to give him. What have doctors prescribed for your children in place of Singulair????

On the fda;s cder web site is a calender of meetings,there is also a calender for tentative meetings,tentively scheduled on dec 10 and 11 is a meeting of asthma allergy,risk management and drug safety,we know they hired public relations so we wonder if maybe they will be there,as this investigation comes to an end,i wonder is there more we could have done,i don't think so,i am perturbed that we were not contacted after we filed our reports,as i wonder how they will get the rest of the story.It is my understanding that these meetings are open to the public,unless otherwise specified,there is no specification on this one yet,i hope if any one is in the Dc area and they have a chance to go they will tell us what is said.I hope they look into the chances of some having maybe perm issues and give us guidance,they have been silent for so long as we have battled this in the dark.If by scheduling this meeting the investigation is over and they have a conclusion and our not going public yet ,well shame on them,if there is one thing we are disparate for is information as to what to do next,heres hoping every one,keep fighting

I am re-posting this from June. I believe that we have many reasons to suspect that Singulair does indeed penetrate the blood brain barrier. I personally believe that under certain unusual conditions that Singulair can cause neurological damage. I tried before to put together a scenario of brain biochemistry that could explain how this can happen. Of course, I am just hypothesizing and all of my ideas will not prove to be totally correct. From the number of postings here regarding neurological symptoms, I believe that there is an answer out there somewhere. Why the FDA is not searching for this answer is a complete mystery to me.

I believe that it is possible that Singulair causes the same biochemical response in the brain that is cited in this study -- thus causing neurological damage.

"Thus, elevated NO production leading to mitochondrial dysfunction, glutamate release, and excitotoxicity may contribute to neuronal death in neurological diseases."

IS SINGULAIR CAUSING THE DEATH OF NERVE CELLS IN SOME PATIENTS? DOES THIS HAPPEN - ALTHOUGH INFREQUENTLY- BECAUSE OF GENETIC OR BIOCHEMICAL FACTORS OR BOTH?

June 12th
2008
2:56 AM
I have stated many times that I am not an expert. I just post what I find. This has been a mind boggling journey for me. This is way over my head but I struggle to read and understand. Finding answers to why children are suffering from neuro-psychiatric side effects is worth the effort.

I have made the following observations.

1. Some quinolines are known to be able to cross the blood brain barrier.
2. Molecules that ionize are known to be more likely to be able to cross cell membranes. So if montelukast ionizes as a result of change in blood pH to sufficient acid conditions, then it could be possible that it does in fact cross the blood brain barrier.
3. We know that there are cysLT1 receptors in the brain.
4. We know that researchers believe that montelukast may bind at the arginine of the cysLT1 receptor.
5. We know that arginine contains four nitrogens. And montelukast contains one.
6. We don't know what happens to those nitrogens. Are those nitrogens converted to nitric oxide?
7. We do know what macrophages create nitric oxide as I posted.
8. We do know that if something cause excessive nitric oxide to build in the brain that there would be damage to the neurons.

Some people may remember when I got stuck at the astrocytes, the cysLT1 receptors and glutamate. I keep looking for research reports that may shed more light on this.

Titre du document / Document title
Nitric oxide causes glutamate release from brain synaptosomes
Auteur(s) / Author(s)
MCNAUGHT K. S. P. (1) ; BROWN G. C. (1) ;
Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)
(1) Department of Biochemistry, University of Cambridge, Cambridge, ROYAUME-UNI
Résumé / Abstract
We determined the ability of pathological levels of nitric oxide (NO) to cause glutamate release from isolated rat brain nerve terminals using a fluorometric assay. It was found that NO (0.7 and 2 μM) produced (4 and 10 nmol/mg of synaptosomal protein) Ca2+-independent glutamate release from synaptosomes (after 1 min of exposure). Spermine/NO complex (spermine NONOate; a slow NO donor) and potassium cyanide (an inhibitor of cytochrome oxidase) also caused Ca2+-independent glutamate release. Preincubation of synaptosomes with 5 μM 1H- oxadiazole quinoxalin-1-one (an inhibitor of soluble guanylyl cyclase) had no effect on NO-induced Ca2+-independent glutamate release. Ca2+-independent glutamate release produced by NO was greater in a low-oxygen medium. NO, spermine NONOate, and potassium cyanide inhibited synaptosomal respiration with a similar order of potency with respect to their ability to cause glutamate release. Because NO has been shown previously to inhibit reversibly cytochrome oxidase in competition with oxygen, our findings in this study suggest that NO (and cyanide) causes glutamate release following inhibition of mitochondrial respiration at the level of cytochrome oxidase. Thus, elevated NO production leading to mitochondrial dysfunction, glutamate release, and excitotoxicty may contribute to neuronal death in neurological diseases.
Revue / Journal Title
Journal of neurochemistry ISSN 0022-3042 CODEN JONRA9
Source / Source
1998, vol. 70, no4, pp. 1541-1546 (29 ref.)

INIST-CNRS, Cote INIST : 4037, 35400007527188.0230

A series of articles published by the Boston Globe in 2001 revealed

that the number of children enrolled in clinical trials in 1997 was

16,000: by 2001, the number reached 45,000. The Globe found that children

enrolled in clinical trials had suffered and died, and that ethical

standards had been violated.

Financial incentives for parents, physicians, and researchers had undermined

children's welfare. Children are currently being recruited with Toys

'R Us gift certificates. Parents in need of money are offered as much

as $1,000 to "volunteer" their children for drug experiments that involve

risks of harm. The physicians

who are engaged in such coercion receive as much as $5,000 in kickbacks

(euphemistically called, "referral fees") for the recruitment of children.

None of these disturbing facts were brought to the attention of the

U.S. Congress when it passed the Best Pharmaceuticals for Children Act

in 2002. The evidence, however, shows that children are being deprived

of existing, more protective federal regulations under 45 CFR 46, Subpart

D, and are being subjected to foreseeable risks of harm and discomfort,

often on the basis of a presumed potential risk for which there is no

empirical evidence. The FDA

acknowledged that before FDAMA the use of children as subjects in phase

I safety drug studies "had been primarily limited to life threatening

diseases and children who had the disease" in question.

The policy prior to FDAMA protected children from harmful experiments

in accord with the 1983 federal regulations (45 CFR 46.404-409). Following

passage of FDAMA, however, federal policy broadened the criteria for

inclusion of children in research generally and for participation of

children entered in high-risk experiments. In 1999 the FDA acknowledged

that the post-FDAMA policy change "led to an increasing number of proposals

for studies of safety and pharmacokinetics, including those in children

who do not have the condition for which the drug is intended."[64

Any time your or your child's physician wants to prescribe a new medication, ask that they check the DailyMed website for the most recent FDA approved drug labels to get information on ingredients and side effects. This website is maintained by the US National Library of Medicine and the National Institutes of Health and has information on 4039 approved prescription drugs. Accurate information may also be found on the websites of medication manufacturers.

Other websites, as well as medication reference books physicians have in their offices, MAY NOT have the correct information.

Many medications, including some inhaled asthma medications, contain lactose, which may be contraindicated in individuals allergic to milk protein.

Don't take chances with your or your child's health. Ask doctors lots of questions and don't be afraid of offending anyone!!!

Read replies to this message.

I also have a child who has been on this drug for about a month and as I sit here and read these blogs the more I am remembering complaints made by my son. He has been getting into trouble at school lately, irritable, angry, sad, leg pains, stomach aches and also having trouble getting to sleep at night. I am an RN and it took me to glance at the pill bottle today to realize that I needed to do a little more research about this drug when I saw that it said "mood changes and depression". I feel horrible because after a great 2nd grade year I was disappointed that he was not behaving as well this year. I know know that the $60.00 wasted and tiring reprimanding was all a waste of my time! I owe my poor son an apology as I will be taking him off of this drug today! More information and advocacy needs to be available especially when core users are children who have little to no voice!!!

I have a daughter who is almost 3 yrs. old. Her pediatrician prescribed her Singulair when she was 18 months so she's been on it for a little over a year. She has suffered from allergies since she was an infant although we've lived in Atlanta and Cincinnati since her birth - two of the worst cities in the US for allergies and air quality!! I cannot tell you how disturbing yet reassuring it is to read all of your posted side effects..I can relate to so many of your experiences! Its so ironic though b/c the initial reason our last pediatrician put her on Singulair was b/c she was feeling so badly from her allergies...but since she began taking it, she has had SO many more issues with not only her health but mental state. She has had serious aggression issues - taking it out physically on other children, her peers and our poor dogs and cat. She has tons of trouble falling asleep at night, is a very picky eater and has unexplained bouts of anger. When it started, we thought it was b/c like so many toddlers, she couldn't express herself. But she began talking at 18 months and could also sign and always seemed to communicate to us in her own way prior to that so that didn't add up. We've had a lot of external changes in our lives in the past year so everyone I've talked to about her issues has assured me that it was due to these and to keep on trying everything we could; that it was only a "phase". But the one thing I keep thinking about is how different she was prior to taking Singulair and how her mental well being changed so drastically from that point on. She was such a sweet, lovable child who was sleeping throughout the night (since she was 8 months old). She had a great appetite and loved trying new foods. She never had any aggression issues AT ALL before that. I even asked her previous caregiver abt. any aggression issues she had while watching her (which was up until 2 months before she started taking Singulair) and she said she never had ANY issues. In all, like so many of you posted abt. your children, she was a completely different child!! After going to her doctor this morning to have her checked for what I suspected was a sinus infection, he told me to absolutely continue giving her Singulair year-round in addition to 10 mg of Claritin (which is twice as much as children ages 4 to 6 are supposed to take!) and Nosenex spray for the next few weeks. It seemed like an awful lot to give a 2 yr. old so I started researching and came across this site. I am going to stop giving her Singulair today and look into some non-prescription alternatives. I take Oil of Oregano for my allergies since I can't handle the side effects of over-the-counter drugs so maybe my daughter can take this as well? I am so scared of how this drug has affected my child and hope that there hasn't been any permanent damage. I feel terrible that I trusted both of her doctors before researching this drug. I am SO thankful for finding this site and for reading your stories and will report back in a few weeks to update you on my little one's condition.

My daughter was prescribed Singulair in the spring and it worked wonders.Since her allergies and asthma don't bother her in the summer I took her off for those few months.Since she has been back on the last few months I notice once and awhile an aggression/depression behavior.I thought immediately that it was Singulair causing this but it wasn't everyday it happened.I believe that activity,schedule,and even food in combination with this medicine that was cause this rare effect.It's no news to parents that all of these things can change a persons attitude and behavior.I also believe that Singulair may just make people more sensitive to their true self as my daughter has always been paranoid and has lacked self esteem.I think that it is trial and error as with any medicine.Try it and it may or may not work for you.Taking it off the market would be a disgrace as it has saved many lives.

I first read notes on this site in February 08 when our Doctor prescribed Singulair. My 7 year old daughter is a silent asthmatic which prompted me to push past the side effect warnings written here and give it a go. Rach had strong side effects for the first two weeks & then seemed to settle, so I persevered with it. The drug didn't seem to have no effect on her asthma flare ups but the doctors didn't believe me and encouraged me to keep going. After 6mths I called it quits and took her off it. She's now back to her normal self. No longer emotional, her school work picked up immensely, no more nightmares or unexplained body aches. She does still have tummy aches but they are subsiding. She's been off singulair for 3 months now. Every doctor and pharmacy I spoke to denied the side effects and promoted the product. To anyone researching this drug, do your little one a favour and don't use Singulair unless it is a last resort. There are so many other alternatives out there.

I have a 4 year old that was on Singulair for 17 days. He has always been a strong will child, yet he was always manageable. Those days that he was on it, and a couple of weeks after were the hardest weeks I have ever had with him. Within days of taking it I began to notice an extreme change in his behavior. He was moody, angry, he was beginning to be aggressive. He wasn't sleeping through the night anymore, and even began wetting the bed, something he hasn't done since he was two.

It was prescribed for his asthma, he couldn't walk five steps without coughing and wheezing. It did work, but I didn't think it was worth it. I went in to see his doctor, she said the aggression wasn't a side effect of Singulair in children, but had been recorded in adults. So she said it was fine to take him off of it. And to control his coughing he could just use 2 puffs of Flovent twice a day.

Well, he's been off of it for almost 2 weeks. His first days off were the same if not worse. He was even moodier than usual. I started thinking it wasn't the Singulair. He became exhausted, sleeping in the day. Was still angry and not sleeping at night.

But as he heads into his 2nd week off Singulair, he seems to be acting normal again. :) Normal for a 4 year old anyway. He's been sleeping through the night for the past few days and has been happier. He's playing again with his toys in a non-aggressive way. He just seems like he's becoming himself again.

I read some things were people said they didn't notice a change in their child, but it's taking some time for my boy to get back to "normal."

My 8 yr old has been on singulair since May. I never put two and two together until reading these posts. He has been having anxiety at night..crying and looking terrified saying he can't stop the scary thoughts in his head. Tonight I felt so bad for him...because I can't make it go away. I am hoping with tonight being the last night on singulair he will not have such a hard time at night. He also says it's very hard to get to sleep at night. Poor kid. I also know he's a sensitive kid but it seems a bit overboard in the last few months....like getting upset and just not knowing how to handle his emotions so he just shuts down. Please message me if you've had similar experiences. I'm calling his dr. on Monday to figure out some other options if there is any. My son started with a cough in March and finally took him to see the dr. in May and she heard wheezing and started him on singulair and then added zyrtec. I know they control his coughing (wheezing...slight asthma) because if we miss a dose he coughs all day the next day. I'm a bit scared to go off it...but hope it stops the anxiety and moodiness. He had his first asthma attack last week too...and I wasn't prepared as we never have had to use the inhaler...so I didn't have it with us. Anyway, hoping he doesn't get too bad taking him off...and I hope he is able to control the scary thoughts by going off of it too.

i'm glad that i found this site...thank you.
I have a seven year old boy and a four year old girl that have both been on singulair for a couple of years. The first year their allergies weren't that bad, so i didn't really make sure that they took it daily...the past year, allergies have been worse, so i was making sure that they took it daily and that they didn't miss a dose. My son was in 1st grade last year and by the end of fall, he was going to the nurses office daily for headaches and stomachs. Where his drawings used to be of flowers and all of us as a family, they started being of monsters. We also noticed that his pupils were dilated more than normal (you could barely see any of the colored part of his eyes) and took him to an eye doctor just to find out that his eyes were fine and there was no medical reason for the dilation. I also asked the doctor and the school to test for ADD/ADHD, with them saying that he didn't have it..At night, both my son and daughter started waking up for no apparent reason (they had both slept through the night since they were about 1) and being very scared for no reason. The mood changes have been more noticeable in my son, but like most, i chalked it up to "a phase" and just part of being a boy....my daughter got clingier and moodier, but i know how it is to be a girl, so i just took it with a grain of salt. My kids have not been on Singulair for approx. a week now, and my son is back to the boy i knew....skipping through the house and yard, catching bugs to just look at them and not pull them apart and kill them, sleeping through the night, no trips to the nurses, and eyes that seem to be normal again...my daughter is actually a pleasant little girl that can't wait til she see's her brother instead of pinching, hitting, and trying to hurt her brother........Long story short, since they've been off of singulair, i have my kids back. my son had circles under his eyes at times and a runny nose at times and we have to find something to help my daughters allergies (she gets eczema and is borderline asthmatic) but we will deal with that and find something that works without harming them.....
Thanks again.

We believe the following are among the most important shortfalls in the conduct of research involving infants, children and adolescents:

Failure to examine alternative methods of obtaining needed information so that research involving risk for children is minimized. The goal should be to limit the exposure of children to trials that seek vital information that is "unprocurable by other means" - as mandated under the Nuremberg Code and as stipulated in current federal regulations - 45 CFR 46 Subpart D - which restrict the exposure of children to greater than minimal risk. Indeed, until the FDA adopted the "Pediatric Rule" in 1998, high risk, phase I trials in children "had been primarily limited to life threatening diseases and children who had the disease for which the new drug was being proposed." It is difficult to justify a shift in policy that will increase children's exposure to pain and risks of harm.
Inadequate review: failure to evaluate risks relative to existing empirical evidence of harm.
Failure to minimize risks, including psychological risks, or to justify them from the perspective of the child.
Absence of evidence-based guidelines for classifying research protocols "minimal risk," "minor increase over minimal risk," or "greater than minor increase over minimal risk."
There is a pressing need to examine cases that resulted in harm to children - and to draw policy recommendations on the basis of that evidence - so that we can avoid causing harm in the future. Such an analysis was carried out by the Advisory Commission of Human Radiation Experiments (ACHRE), and for that reason ACHRE stands apart from all subsequent ethics advisory committees whose recommendations were unsupported by evidence.
Absence of boundaries to limit the level of risk and pain to which a child may legitimately be exposed.
Pervasive conflict of interests of all involved - including, and especially, institutional review boards that have been shown to rubber stamp approval of harm producing trials.
Absence of an independent child subject's advocate to monitor his/her well-being.
Lack of accountability or enforcement of federal safeguards.
Lack of penalties for those who violate ethical standards.
................................................................................................................................................................................................................................i found this on the best for childrens pharma act websight,it was a letter of worry from several doctors

My 7 yr old daughter has been off of Singulair for 12 days now. The change in her personality is amazing. She experienced two nights of strange dreams and waking in the middle of the night. We put her back on Flovent once a day as a substitute. Her aggression and frustration went away within days. She is so happy and content with herself. I can see that she is no longer frustrated by emotions that she could not explain. She's silly, funny, happy. She no longer hates us, pulls her hair, or tries to slap herself because she's thinks she deserves it. She has been on the drug since she was 3-1/2. We were doing family therapy to try to help her. This is no longer needed. She's back to her old self. What a shame no one warned us of this potential side effect. I also wondered how I missed the news story since I just found this site in September 2008. The news story about Singulair came out in March - just around Spring Break. Since we were out of the country, I missed the news. Isn't that a convenient time of the year to break a story? I'm sure many other families missed the news.

Today is 4years exactly that Matt had his one and only asthma episode,that sent us done the road of singulair disaster,7 months of the drug now thanks to Kate who went public with her story.Each new day brings more hope for a full recovery,although the road is long and strewn with guilt and anger.First i was angry with my doctor,then Merck now the FDA,but the guilt always stayed with me.Ive spent hours on wouldas couldas and shouldas but none the less it is what it is.I have had an education in things i really didn't want to know,the medical system,the justice system,and our government.I have written hundreds of letters reported 3 times to the FDA,never a response other than your email was received,called and reported to Merck twice,they were always ready and willing to take my info,so today i wrote to the FBI asking if they could investigate corruption at the FDA,proberly they will laugh and trow it out,or maybe even put me on a list of some kind,but i will leave no stone unturned until some one explains to me how this happened in America

I have a 26-month old grandson who has been on Singulair for "27 DAYS". His pediatrician knows that his immune system is already compromised due to some developmental delays. However, before he started taking his Singulair he was a very happy, funny and loving child. Within 2 weeks on this medicine we started to notice a few changes in him. He started waking up at night "screaming" and he has been sleeping through the night for at least a year now. And when his mother would go in to get him out of his crib, he would be so frightened and afraid to leave her side. It would take her a very long time to settle him down and put him back down for the night. At the same time, he started not wanting to drink his normal daily glasses of milk or eat his regular meals. He was simply a mess most of the day and would fuss, cry, bang his head and we were having a very hard time trying to figure out what was wrong with him. He is not yet talking due to his delayed speech, so he could not tell us what was going on. Yesterday, I told my daughter let's look at the side effects of Singulair since it was the only thing that had changed within the last few months. When I found this site, I could not believe what the parents/grandparents were saying about their children on this drug. We immediately took him off Singulair. This will be his second day without being on the drug. According to my pharmacist, it will take approximately 50 hours for it to get out of his little system. The pharmacist had not heard the latest that aired on the TV station, so she asked me to call her back in a few days to tell her how my grandson is doing. Parents should be able to trust the medications that are prescribed by their Pediatricians, especially at such young ages. My daughter is REALLY UPSET and has a call into my grandson's doctor. Thank God I found this website. I simply searched on "side effects of Singulair in children" and this site came up. I do believe the Lord is watching over my grandson. Thanks.

I have a 4yr old boy who has been on singulair for 5 months. Before he began singulair he was the most happy, kind, gentle, loving boy. We had an awesome close relationship. I enjoyed just sitting there watching him play. I could not wait for him to learn something new, but EVERYTHING has changed now. I took him off of singulair on Sept 19, 2008 after accidentally running into this site while looking up children and OCD. Thank God I did. It has been 12 days since I found this and took him off. I couldn't type then because I was to upset. My son who never had ANY mental problems or anxiety is now completely riddled with it. Instead of playing all day care free like 4yr old are supposed to do, my son spends his days now clinging to me in fear that I may leave or go into a room without him and he will not be there to open the door. He obsessively has to open every door now. He spends his days getting upset at the smallest things. He now gets mad at everything I say, or I don't say it right. Our relationship is not the same now, and I am devastated. Before Singulair he slept through the night every night. Now he wakes up every couple of hours to go to the bathroom and say "are you still there mom?" ok "I love you" "Don't let the bed bugs bite" I have to answer "I love you to" and "you either" If anything different is said he will go nuts, and he will obsessively say this over and over and over again. This is not my son. He is a totally different person. I am so very scared that this poison has permanently ruined him. I mean he is so young and his brain is developing. It has been developing with this poison in it, that has ruined him. It has been 12 days and he is still doing the same ocd stuff. He still seems really agitated. His muscles hurt, his tummy hurts, his eyes hurt, his ankles hurt, and he has diarrhea. My beautiful boy is now mentally and physically SICK because of singulair. I feel really bad to, because I did not know at first that the singulair was causing this and I was always getting on to him for his behavior and putting him in his room. At pre-school a couple of days after first giving singulair to him he started crying ALL DAY at school, and I made him stay there because I thought it was just because he had gotten a new teacher and he needed to get used to her. I feel terrible!! Does anyone know if the ocd will go away or has he now learned the behavior?

Hi,
I'm a 38 year old woman who went on Singulair in September of 2006. By December of that year I started experiencing heart palpitations,dizziness,and nightmares that stayed with me in my waking hours. By January of 2007 I was having full blown anxiety attacks. My doctor ran every test under the sun and I went to several therapists. By the end of January my doctor had me on Effexor, and several other short term aids such as atavan. The summer of 2007 I started experiencing stomach pains and sever diarrhea. As much as I loved my 20 pound weight loss, it was not a lot of fun. Again every test under the sun showed nothing. This spring I heard of the concerns of Singulair and immediately went off of it. Within a few weeks I felt like my old self. I am still weaning off of the Effexor and my asthma is not as good as it was on the Singular, but it is worth having my health and my life back. I feel that Singular almost ruined 2 years of my life. It should be taken off of the market.

I aged ten years in a month. My legs lost any muscular power and I needed help to get up our 3 steps to the front door. My eyes are sore and my balance is also affected. What I do not know is how long am I going to be affected like this. I began to think that I was starting with either motor
neurone disease or Parkinson's disease.
Muscle weakness, loss of balance, bad dreams,anxiety, irritability.joint pain.sore itchy eyes and difficulty focusing on printed pages.
A., Yorkshire, England.I am 69 years old and prior to Singulaire I was pretty fit for my age.

Wow- this floors me. My daughter is 20 now- we had her on Singulair for years for her asthma. She suffered from horrible leg pain, but she was a 4-sport varsity athlete and we attributed the pain to over training.

Her first year at college she started suffering from severe depression and lost a lot- I mean a LOT of weight. She went about a year and a half with no period due to low body weight. We wanted to check her into an inpatient treatment center for eating disorders but couldn't because she was over 18 and didn't want to go.

In June we sent her to a new allergy doc who retested her and switched her from Singulair to Symbicort as the Singulair was not managing the asthma well. It was like we flipped a switch- she stopped having vision problems, stomach pain, and insomnia almost overnight. She has gained back at least 10 pounds and is looking like her old self again.

I'm so glad we stopped the Singulair, even though it was accidental. A year ago, we thought we might lose our bright and beautiful daughter. We had no idea it could be as simple as the asthma med. I'm telling everyone I know about possible side effects of Singulair.

If you google the words fda singulair side effects......the third result down is a link to the FDA's consumer information page on Singulair.......the information has NOT been updated since 2001. Why have they not updated this since 2001?