Singulair Side Effects - Hype or Hazard?
The Food and Drug Administration issued an 'early communication' yesterday that they were "investigating a possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide."
It is important to note that this 'early communication' is not any kind of alert or warning and that no link has yet been found between Singulair and suicide. Instead, as with all medicines, the FDA tries to trace back reports of problems that people have while they take a medicine to see if they are actually caused by the medicine or are just a coincidence. The report on Singulair should be done in about 9 months.
While your kids don't need to stop taking Singulair for their allergies or asthma, it is a good reminder to monitor them for any new symptoms or problems that they develop once they start taking Singulair or any other medicine. And then report those problems or side effects to your pediatrician and the FDA through the Medwatch Reporting System.
Related:
FDA Early Communication About an Ongoing Safety Review of Montelukast (Singulair)
Medwatch - Reporting Medication Side Effects
Allergies
Asthma
Comments
What then exactly is the value of the FDA releasing this kind of news release. You’re saying this represents nothing solid and no alert is being issued. Why create angst and indecision about what to do. This is just another example of the incredible incompetence of government.
What then exactly is the value of the FDA releasing this kind of news release?
Despite the danger that the news media will make more of it then it is (which they did), there is value in that it may bring more people to report mood changes and even suicides that could be associated with Singulair that they may not have thought about before.
I had my child on singulair and took him off over three years ago because I noticed changes in him. It seemed to be the “wonder drug for his asthma” but I did notice severe mood changes. I recall mentioning this to his pediatrician. They pretty much discounted this. I also thought it upset his stomach as well. I still notice mood swings. This makes me very sad. I am sure more parents will speak up.
Our son began taking Singulair and Allegra 4 years ago for severe allergies. Within a month he began treatment for panic attacks and for 4 years now has tried to go off his anti-anxiety meds but keeps having panic; (racing heart, respiration). NOW we see the correlation between the timing off the allergy medicines and the panic attacks. I’m sorry to say it never occurred to us before. We have called him at college and said “Get off the Singulair!” It’s worth a try!
my grandchild has only one lung and has been on this med for 8 yrs and now he has bad mood swings and stomach pains he just goes crazy i need some help he is 11 yrs old
I was on Singulair for asthma and allergies as a college student. I noticed that I started getting migraines as well as severe pupil dilation. I then had to get an EGD for stomach pain and had insomnia as well anxiety and depression. I went off the Singulair, strongly suggested by my mother who correlated the timing of these new symptoms with the new use of Singulair. I tried going off of it and within three months had NONE of these symptoms. I think it is a terrible and dangerous drug that should be taken off of the market!
My 5 year old was on Singulair for 6 months. He immediately turned into an uncontrollable child. He hated himself, everyone around him, and he would scream that he just wanted to die. There are no words that can express the pain my family and I went through while he was on it. A month ago, my husband found this site http://www.medications.com/se/singulair and we took our son off immediately! It’s been a month now since we took him off and he is 100% back to normal again…our sweet loving, compassionate boy has returned to us. People have been complaining of these side effects since 2003! Why hasn’t anyone listened? My son was almost diagnosed with Autism for gosh sake! Children are being put on the “fast track” with Ritalin or other mood enhancing drugs because of the side effects of this poisonous drug.
Yes, it did keep his asthma at bay, but I’d hate to think of what he would have done if he was older and actually knew what killing himself meant!
Take note, my story happened before the “news” broke on the Singulair/Suicide link.
My daughter has been on Singulair for 5 years and has not had any difficulty with the side effects that others are describing. It has been a wonder drug for her and her asthma/allergy symptoms. She could be the poster child for Singulair and how it has worked. It is very sad and very scary that others have had a very different and such a different and horrible experience with it. I hope that the warning has helped some realize why their children have had such an adverse change in behavior and now can do something about it. I don’t think that the FDA overreacted; but I also hope they don’t react further and say that this medication is not safe for anyone and the risks outweigh any benefits-unless they can prove it. Everyone should always read the warning labels and decide if the benefits outweigh the risks and not put themselves in danger because a Dr. made the decision this is what will be best for you.
[i]People have been complaining of these side effects since 2003![/i]
Yes, the package insert has warned that some children might have some problems with “drowsiness, irritability, agitation including aggressive behavior, restlessness, insomnia,” etc. since 2005. That made it a good resource to look to if a child began to have any new symptoms after taking Singulair to see if could be related to the medication.
It is important to remember that almost any medicine can cause significant side effects for certain children, and if your doctor doesn’t connect the dots, you should ask if there could be a relationship between the new medicine and the new symptoms. There are even some children who get irritable and aggressive when taking Amoxil, which is considered a safe and well tolerated antibiotic.
I’ve had a few younger kids in my practice who developed a change in behavior after starting Singulair, and they quickly got back to their usual behavior after stopping it.
The problem is that since so many other kids don’t have problems with Singulair (and many kids have behavior problems who aren’t taking Singulair), it is easy to dismiss the medication as the cause of a child’s symptoms, which can lead them to continue to take it for months or years and continue to have the side effect unnecessarily.
Being in the news lately should raise awareness and prevent this from happening any longer.
Vincent, why is it that so many children and adults for that matter, suffered and their doctors didn’t put 2 and 2 together? Is it because Mercks updated inserts were not metioned to physicians or pharmacists? Why is it that thousands of children have been diagnosed as having mood disorders and been put on Ritalin or some other mood stablizer because of these side effects? It just blows me away. I’ve spoken with numerous child psychologists, physicians, pharmacists, and none of them knew these side effects, and told me that my child could not be experiencing these side effects from Singulair. It wasn’t until I updated them all after my son did a 360 that they started to think. These are some serious side effects that parents need to be warned of.
Can you tell me something? With you being a doctor, I would like to hear from you the importance of leukotrienes in our bodies. This is what singulair blocks, can you explain that to me? There has to be an importance of these, and when they’re blocked it does something chemically, creating this rage in singulair patients.
I am starting to put 2 and 2 together and the timing of my son’s emotional issues correlate very well with the onset of the use of Singulair. He has been taking singulair regurlarly for 7 years. He DID take 3 drug over doses resulting in hospitalization and then being placed in therapeutic boarding school 2 years ago. Of the many doctors, therapists etc. he has seen in the past 7 years, not 1 doctor EVER correlated singulair to his problems. He has been off the drug since March 29 and reports signifcant improvement in his mental status. I think the FDA needs to step up it’s warnings and make sure that EVERY patient is aware of this drug’s possible life altering side effects.
im shockd my son has been on singulair for about a year and we went to the dr today and she gve us this information and a new prescrp for a diffrnt drug but now im kind of scared to give my kid anything there have been major changes in my sweet little boy im sad to think it cld have been avoided
My son’s side effects are completely opposite of what most are saying. He has the mood swings and acts way out of character (in a bad way) when he DOESN’T take his Singulair. I’ve kept track of his school behavior chart (he’s in kindergarten) and his worse days have been when he’s missed a couple of doses in a row or something like that. When he’s taking it consistently, his behavior is good and he gets the good color
We’ve began keeping a calendar chart by his medicine to make sure we don’t miss any doses and if we do then we’ll be able to track it. We’ll see.
I have asthma for 20 years and couple years ago my pulmonologist prescribed sigulair to me.
It did not work for me, I started using albuterol way too often, may be because I was on inhaled steroids most of my adult life.
I barely have any asthma symptoms with advair use.
During a news broadcast I heard about the potential for singulair to cause suicidal ideation and other harmful side effects. This triggered me to investigate my daughter’s regimen more closely. I believe this medication was causing night terrors which subsequently have stopped since I discontinued this medication for her.
My daughter has been taking Singulair for about 6-months. She has suffered wild mood swings, but we assumed it was the steroids she was taking for her asthma, but after finding out about the issues with Singulair we have taken her off of it. It has only been a few days, so we don’t know what will happen with her moods. What most concerns me is that I only heard about the issues through a friend even though I had taken my daughter to the doctor just a few weeks ago for her mood swings and no one said a word about the drug.
My son has been on Sungulair for over 2 years and he is still the same sweet, kind, compliant child he always has been. People only report the negative and for the 10 bad comments there are thousands of kids who feel so much better now. Not suffering from chronic sinus infections, headaches, allergy onset of croup, and other upper respiratory infections. We use to have these monthly -no more. New child who is healthy and can play and enjoy life now!
I have been on singular for about 3-4 yrs. I have asthma and my Dr. put me on it as a preventative treatment. I have never felt better! I rarely need to take my allergy medicine now due to the use of the singular. I am scared that they will take it off the market! It has helped me feel better about my asthma . I haven’t had but 1-2 asthma attacks in 3-4 years. I am 47 yrs. old and I know this is a pediatrics site but, I think some medications should be studied more for the use of singular and children. Children are more sensitive to many medications. I learned alot when my daughter was diagnosed with ADD and panic disorder. We went through alot of different medicine changes till we got the one that was right for her. Then she was better, and her grades all went up and she said she even liked the way she felt. Not jumping out of her skin anymore. She was in first grade then. She is now 22yrs. old. She is doing great.
My son was on Singulair for 4 years. The years prior to him being on singulair we had countless emergency room visits and bouts with asthma attacks. My child could have been a poster child for singulair as well. But once the symptoms were released this past winter, I too put 2 and 2 together of his side affects. His side effects were headaches every other day, haluciations, mood swings, inattentive and stomach cramps. Although, he never had any suicide thoughts, he did have bouts of depression. I look at photos of my son from the past four years and he never appeared happy even during birthdays and christmas. He always looked depressed. As such, I’ve taken my son off of singulair 3 weeks ago. Thank God he has not had an attack, however, he has complained of not being able to play sports because it’s hard for him to catch his breath. He has not had a single headache and he is smiling more and is attenetive. So I’m looking for other Asthma maintenace such as Advair. Does anyone know of any holistic vitamins or solutions to Asthma care. Please reply Thanks
We have had four asthmatic kids on Singulair. It’s a wonderdrug for asthma – just amazing. The weird thing was, they all developed behavioral issues as their asthma got better. This went on for years. Then I started taking it this year, and within 8 weeks I was in a deep depression. I stopped taking it, then I took one kid off of it. The other kids came to me and said, “Why is HE so happy all the time”. Now they are all off it, and our house is so much more peaceful. The effect is very, very dramatic.
I’m trying to figure out how to use the FDA’s Adverse Event reporting system. It’s scary. It’s not clear – it almost sounds as thought if I send the Adverse Event report in, it grants the FDA, and possibly Merck, access to our medical records. There are TWELVE PAGES of instructions. If I were trying to design a system to DISCOURAGE FEEDBACK, this would be it.
So that’s how this drug can be on the market for so long, and the side effects not be reported. And it DOES Work great for asthma. But that’s not worth our sanity.
I’m trying to figure out how to use the FDA’s Adverse Event reporting system. It’s scary. It’s not clear – it almost sounds as thought if I send the Adverse Event report in, it grants the FDA, and possibly Merck, access to our medical records. There are TWELVE PAGES of instructions. If I were trying to design a system to DISCOURAGE FEEDBACK, this would be it.
The 12 page ‘Form FDA 3500 – Voluntary Reporting’ includes instructions and the pages your doctor would use to submit a report about adverse effects from a medication to the FDA.
The actual form is only 2 pages and most of it is pretty self explanatory, so you may not even need the instructions for everything. For example, the reports explains how to enter everything from your weight to the date that you filled out the report.
I am pretty sure that you are only granting the FDA and the manufacturer access to whatever records you are sending them. Unless I missed something, you aren’t granting them access to the medical records at your doctor’s office or anything extra. They may follow up with your doctor and ask for more records though.
And it says that everything is kept confidential.
I think the stuff about Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule is so that people understand that it is not against HIPAA rules for doctors to submit a report about a patient’s side effects to the FDA.
Hi All I am a Mom of 2 children on Singular -
One is 8 yrs and the other is 3 yrs.Both have asthma and allergies. Both are sweet kind children but they do have their momoments. My 8 year old is fond lately of saying he hates everyone and hates this family. Does he mean it yes at the time he does but 10 minutes later he wants a kiss from me. Very typical of children of this age especially when they have both older and younger siblings. I also have a 13 year old. People know your children. Know what is age appropriate and what is not. Also, my children are only on the singular during their individual trigger seasons. If your children are taking singular for allergy reasons they should only be on the medication
during those months that trigger thier allergies. They must be tested for what thier allergies are! Stop using pediatricians that prescribe allergy medications without proper testing! And Parents (no offence Dr.Vincent)You have to be your own DOCTOR. ASK QUESTIONS? AND ASK THEM AGAIN AND AGAIN AND OFTEN. LOOK UP INFORMATION THAT YOU ARE GIVEN MAKE SURE THAT IT APPLIES TO YOU OR YOUR CHILDREN. Know why you are being given the medication, how long should you use it, when should you use it and what should you do if you notice behavioral changes,no changes or very little change. Also, allergies and asthma in children can change from year to year? Be aware? Get them tested each year for their allergies and asthma. Just becasue they needed medication (singular) last year at this time means they need it this year even if they have the same symptoms. They could be triggered by somthing different. Also, There are many hoalisticed remedies for allergies, check those out first before get prescribed medications. Very disturbed by what I have read here today.
My son has been on Singulair for 6 years since he was 2 years old…he has been diagnosed with OCD and has radical moods swings and depression. I have never connected it to singulair until I went to this site today. He had a severe meltdown this morning that lasted about 1 hour and I just started investigating whatever I could to try and get to the bottom of this. He was a very calm, easy baby and toddler. He did get frustrated easily, but I think most toddlers go thru that. He has progressively gotten more aggressive and angry especially in the last couple of years. I have sought the help of therapists and my pediatrican, but no one has ever mentioned a problem with singulair. My son has often told me he wants to die and talks about death a lot. This morning after he calmed down from his rage, he had his head on my shoulder and he said, “I just can’t be happy, Momma, I don’t know why.” This is simply heartbreaking! He is NOT going to take singulair anymore. I can only pray that he recovers from these adverse effects like some of the other children I have read about on this site. It scares me that this may have changed who he is for the rest of his life.
My 5yr old son has been on singulair since he was 2. I recently changed allergists and have an appt with a new one in a few weeks. I was so upset b/c I want my son to stop taking medications! I feel like he’s been taking Zyrtec and Singulair forever. I google searched how long should my child take Singulair and found this site. I just have to say he will not be taking this medicine after tonight! The descriptions above of the mood changes, upset stomach..that is my son. So bad my husband made a comment that he might be bipolar b/c of his mood swings. Happy one second crying the next. He recently went through “hating” everything also. I tried to stop it once in the spring and he had a small asthma attack so I got scared and started him up again..it could have just been that time of year. All I can say is I’m done with it and we’ll just have to look for other options if he starts to have problems. 3 years of this medication is just too long…
Thanks
While some drugs may indeed has side effects, I get so sick and tired (no pun intended) of parents blaming medications for their childrens’ behavior. Perhaps they are behaving the way they are behaving because that’s the way children sometimes behave. Or questionable parenting is causing the children to act the way they’re acting. I am not dismissing the underlying possibility of Singular being at the root cause of a small minority of the complaints, but come on.
Oops. Typo. I meant “have” in the first sentence, not “has.”
Wow, Dave, your ignorance is mind-boggling. My son started having severe OCD symptoms two weeks after taking Singulair. Before that (for the first 9 years of his life), he had no behavioral or mental health problems whatsoever. Now he has had to go on Zoloft and have intense therapy (not covered by insurance). Singulair is EVIL, and I shout that from the hills whenever I get the chance. It should be BANNED. I hope there is a class action resulting from Merck’s CRIMINAL BEHAVIOR in regard to this drug, and I hope the lawsuit bankrupts Merck.
I have asthma since I was 14 years old, now I am 30, I did not have much asthma for all these years, and I used Albuterol inhaler when I had an attack, it was smooth going till this May when due to stress I could not control my attacks, so my physician prescribed singulair, and since the day #1, I have noticed bizzare changes, like obsessive compulusive behavior, forgetting often, no interest in life, stomach pain, mood changes, I am completely changed, I have been prescribed this for 3 months, I am really planning to stop this immediately.
My daughter is 4 and has been taking singulair for the last 2 months and I thought I had the devil incarnate living in our home. I am the one feeling suicidal by her behaviour, yes she has typical 4 year old tantrums but lately she is very hard to calm down once she gets upset. I am terrified of bringing her out to meet friends because the slightest thing sends her off into a meltdown and he can be violent and uncooperative. I am at the end of my rope thinking I am a bad parent, but I decided to check up if maybe some of her medication was making her so violent. I am taking her off singulair right now, and hopefully we can all return to normal.
My 8 year old son was put on Singulair about 5 months ago by our family doctor. He was having so many sore throats due to drainage, causing fluid behind his eardrum, etc. caused by allergies. These problems seemed to go away, and I thought this was a great drug for him. However, the new school year has begun, and we have had problems with him daydreaming constantly, unable to pay attention in class. He realizes it himself, and is very frustrated. A.D.D. has been thrown out there, however, he is a very bright kid and learns easily, but couldn’t focus. He was fighting with my other son more frequently, and crying over everything. His self esteem was so low, and it was really worrying me! I had a discussion with his teacher about my concerns, and she was also worried about him. She had asked if he was by chance on this drug, and I was shocked because he was! She had a student the year before that suffered in the same way. They spent a long time investigating, and linked it to Singulair! That is all it took! That night I made him stop taking it! It has not quite been 1 wk yet, but already, we all notice a huge difference, including him. He comes home smiling, goes to bed smiling, and is so happy with himself that he can focus on his work! He is even getting along great with his brother! Needless to say, I will no longer be giving him this drug. I was just thankful someone gave me heads up on this or who knows what the year would have been like. If your child complains of or seems to daydream more than usual, try not giving him/her this drug, and give it a shot. It is worth getting your child back.
Two years ago our family was going through the same kind of hell that so many of you are reporting – our previously bright and happy son developed terrible anxiety, lost interest in school, said he hated everything, including himself and wanted to die. We considered every cause in the book, questioning our parenting, wondering if he had suffered abuse or trauma unknowingly, or if he was developing OCD or bipolar. A chance comment from my sister about another medication made me wonder about Singulair. ALL OUR DOCTORS ASSURED US IT WAS PERFECTLY SAFE. Only when I found a website with more stories like the ones here did I dare consider taking him off it. Even then I felt unsure, because no medical authority would confirm this was the problem.
Well I’m here to tell you that our son is a whole new person. When I hear him break into giggles watching a funny movie I am so relieved because for awhile there he had completely lost all sense of humor, he was so out of it. Now he can make friends, complete homework assignments, deal with conflict – he can function in the world without freaking out over every little thing! Two years ago, I had lost hope that this would have been possible.
These side effects are a REAL problem – all your stories are the classic Singulair story – I have read hundreds of them now. Stop the drug, get help with behavior therapy, and prepare to be patient, but you will see results. I don’t know what exactly goes on in the brain of those affected, but there is some healing that needs to be done, depending on how old the child and how long they were on the drug. Our son’s mood lifted almost immediately, but he had to relearn a lot of social skills, and the anxiety slowly faded to a garden-variety type (e.g. he still worries about bad weather, but now he just talks about it, rather than act off the wall). I would say he was off the drug for about 9 months when we noticed a more permanent shift, and could truly say that we had our son back.
Also, these side effects don’t always show up immediately. Plus of course children do go through developmental stages, it can be very hard to work out what is a normal tantrum and what is a problem. But I know that those of you who have turned here in desperation KNOW that something is not quite right, and you should trust that. Pay no attention to the nay-sayers who have no business making comments.
I feel so thankful to the parents who came before me and were willing to report their stories online or in the news media. I am frustrated that this story has not really broken out past these blogs. The fact that there are stories here from just last week tells me that we have a lot more work to do to get the word out.
Good luck!
My 7 yr old daughter has been on Singulair for about 3 years. We have been frightened by her sadness and talk of hurting herself. I feel her frustration in trying to understand her moods. She can’t articulate how or why she feels this way. We have a very warm and loving family with no trauma or stress going on. We were starting family therapy this week to try to figure this out. I did a search yesterday on the internet to see if anyone had ever reported a connection between any of the allergy or asthma medications that she has taken, and I was sickened by the stories that sound so much like what we are experiencing. I took my daughter off Singulair last night, and she woke up at 4AM with a nightmare, and told me this morning that she had strange dreams all night long. She was a happy giggly girl this morning, despite what I expected to be a sleep deprived child. I know 24 hrs can’t make that much of a difference, but I didn’t tell her why we were taking her off the drug. So that did not influence her mood. Her allergist of course said that there is no evidence of a link with Singulair, but we agreed to switch her to her old prescription of Flovent and see what happens. I so wish our allergist had mentioned that mood swings and depression were something to look out for. It would have saved us all a lot of heartache. For those of you who don’t believe there is a connection, you are not the parents of a child who goes from a happy preschooler to a dark and brooding child. Thank goodness for all the parents who are posting these stories. I hope to report we have our happy child back a month from now.
I saw an allegy/asthma specialist this week for my 19 month old son with severe excema. Has had it since 6 wks of age but broke out in hives a week ago and asked our GP for an allergist referral. He prescribed Singulair chew tabs. Sort of concluded the excema and asthma are linked because I have mild asthma (80% chance he’ll develop it). Has anyone experienced the same situation re: singulair and excema? I haven’t given it to him yet after reading the side effects and warnings and the fact it isn’t recommended for those under 2. I wonder if a little itching is better than the risk of any of the side effects.
If you want to help with the awareness on this drug ,go to medications.com and join the advocacy group.There is a link and it is easy to follow,I for one ,want this drug relabeled and I for one, know how serious the side effects can be.My child was fine mentally and in two weeks he was gone .Suicide was not an end to a long mental illness,it was the lack of disclosure of mood and behavioral changes to look for, while taking this drug that led to his death!!!!!!!
wow, these comments are pretty disturbing. but i do want to add that i’ve been on singulair for over 4 years and have had no issues whatsoever. i’m 43, so that could be the reason. certainly there is a difference between adult and childrens’ bodies and nervous systems, so that could be a big factor. maybe there’s a chance a different or lower dose of singulair will be offered–maybe it’s the dosage itself or concentration of medicine that is off. but so far, no problems at all for me.
i understand that any parent would be concerned, but i also think it’s important to look at the benefits and risks and severity of those side effects. i would definitely be concerned if my young child said he wanted to kill himself, but i’d probably be less concerned if they were having bad dreams. so you have to consider: are edginess and bad dreams worth taking a kid off a drug that could save his life? coz let’s be real–asthma is life-threatening. i’ve known 2 people already that have died from an asthma attack.
some people have mentioned advair, and frankly, THAT is a drug that i would NEVER take. it even wound up on a list of ‘drugs doctors would not take themselves.’ advair has something called a black box warning. basically, the drug was linked to sudden death in a lot of study patients, because of one of the 2 drugs that it contains. that scared me, coz it’s right there in big letters on the box, and in their commercials.
i dunno. i don’t want to defend drug makers necessarily, because i know they’re in business to make money [like every corporation is]. but medicine has its place, and for me, singulair has made my life so much better. i wouldn’t want to take a steroid drug like advair because i read that inhaled steroids are linked to osteoporosis, which runs in my family. maybe i’m wrong.
just one last thing–someone mentioned their child was on singulair and allegra. an allergist put me on that combination, too, and when my regular doctor found out, he got mad and made me switch to zyrtec, because he said the doctor should have known that the combination of singulair and allegra is dangerous. something about a link to irregular heartbeat or some such thing.
i guess we’ll have to wait and see if they find any real link.
If you have questions about mental health side effects to singulair, go here: http://www.parentsforsafety.org/17601/index.html
We have stopped singulair for our 5 year old who took it for two years, coincidentally the 2 years we have been struggling with these side effects. We stopped 4 days ago and are seeing many fewer of the problematic behaviors and frustrations and tantrums pass much quicker. He’s becoming the reasonable boy we used to know! Keep your fingers crossed the improvement continues. I am worried about the asthma flare ups since singulair did seem to keep them under control but the mental health of my son tells me to find something different to take.
my daughter who just turned 3 has had asthma since she was 6 months old. she had be on abuterol and pulmicort for 3 years she was always always sick. she went to the er many times. finally her dr. put her on singular. i cannot say how much it has helped her. she is so much healthier and happier. she can play outside with other kids and no have an asthma attack. I LOVE SINGULAR.
Like Tracey, my four year old son has just been prescribed Singulair for Excema. Any parents out there that Singlair has helped for excema/hives alone?
We’ve tried everything. I will be giving my son the Singulair – because I feel there are no other options – his excema/hives/allergies have just got worse the past six months – he is up throughout the night and his behaviour is affected due to the excema/sleep disruption. I’d like to hear if any other parents have children on it, not for asthma but for skin/sinus allergies. Thank you. Jo.
My 11-year-old son has been taking Singulair since he was 9 years old. At that time he was diagnosed with bronchitis and his pediatrician put him on Singulair. I never questioned him or asked how long he should be on this drug. Looking back now, I can see that my son struggled with mood swings, stomachaches and headaches. It didn’t take much to set him off and he would just walk off and not be able to deal with the normal conflicts in life. About 1 year ago, my son was diagnosed with pneumonia in Dec. and then each month he got sick, sometimes a chest infection and other times sinusitis. I took him off of Advair thinking that may be the problem. He still suffered the mood swings and stomachaches this summer but no major illnesses until Aug. when his Singulair doseage was doubled. He had been taking the 5 mg table once daily and his asthma doctor prescribed the 10 mg tablet because my son could now swallow tablets. Within 5 days, my son got ill and I put him back on the 5 mg tablet. Nov. 1 I decided to put him back on the 10 mg tablet because I didn’t want him to get sick this winter and guess what? On Nov. 4, he was diagnosed with bronchitis. On his asthma doctor’s recommendations, I kept giving him the 10 mg tablet but he started making suicidal comments and finally on Nov.19, I realized that Singulair was causing the suicidal comments and it seems extremely coincidental that my son got so sick a 2nd time after going up to the 10 mg table of Singulair.
I can tell you that after 5 days of having my son off of Singulair, I have a new son. He is happy and he laughs alot and loves to play tricks on people. Before, he was melancholy and didn’t even want to get out of bed. There was even one day when he called me from home and said, “Kill me!” and he hung up. Talk about scary! My son has not made any suicidal comments whatsoever since being taken off of this medicine. I’m so glad that I finally realized what’s causing my son and our entire family so much grief. I just hope that he doesn’t have an asthma attack. Thanks for this website and to everyone who contributes. I hope that my story helps.
I have been on Singulair for about three to four years and it works very well for me. Before Singulair, I had tried Theophiline, Tilade, Advair, serovent, and Flovent for my chronic asthma. I like this medication best because it treats my allergy symptoms as well and lessens the effects of my many food allergies. I regret that so many have had such bad side effects with it; however, I hope that it will not be pulled from the market for those of us who do find it to be a blessing. I hope other options will be created for those who need a better one for themselves or their children.
I was just put on singular 2 weeks ago, for chronic athsma. Since then I have had the tiredness, muscle aches, and high fever twice. I’m keeping careful watch of my side effects and hope that they improve because my athsma (and use of rescue inhaler) has gotten better since this medication was started.
I have a Ph.D. in pharmacology. What makes me mad is that I specifically asked my MD what the side effects/dangers were . . . and he was like, “none, this medication is totally safe.” I also asked how this medication worked, I specifically asked, “Is this a classical antagonist?” He couldn’t answer my question. If my side effects don’t improve I will definitely let him know and stop the medication.
The bad thing is that there are so many people who don’t even know the right questions to ask. Even if they did I am sure that there are many doctors who prescribe medications every day without the slightest inkling of how they work. You must be proactive about any medicines you are taking and research anything you put into your body thoroughly.
LOL. I was just reading the doctor’s bio. I work at UT southwestern in Dallas too. I wish I could find an adult internist as knowledgeable as he is.
i have been on singular for at lest 4 years know i am seeingthe side effects that is me i was in acomma for aweek and a half have hullicinations, crazy dreams even hear things at night laying on my left side. I think i am going crazy sometimes know it is hot my othr meds zoloft seerquel i even went of tem but took singular
i have now just discovered that i believe this singular is giving my daughter anxiety attacks….there is no question about it.i will be taking her off of this drug asap.
Be very concerned about giving your children Singulair. My child took it for several months when he was 9 years old – he became obsessive compulsive – very distinct behavioral changes – he had to wipe down his bed and chair or seat in a car repeatedly before he would sit down or lay – he become obsessive compulsive. I lay in bed trying to find out what was different and it occured to me that it may be the Singulair. I flushed them all down the toilet and within a month or so he was back to normal. I read several posts of parents whose children exhibited agressive or compulsive behavior after taking Singulair. My child was agrumentive and not himself also. Several parents had subsequently put their children on additional drugs to combat these side affects, not realizing that Singulair was the problem. Be very concerned and aware of the possible side effects of this medication. My pediation turned a deaf ear to anything that I told him during and after these discoveries. You need to be looking out for child. The pharmaceutical industry and many physicians are looking only at their bottom line.
My grandson was put on singular and there were immediate changes in his behavior. He started having horrible temper tantrums and after taking his dose at night literally ran around like crazy. He became unreasonable and often displayed violent tendencies. Before this medication while he was a normal two year old displaying normal behavior this medication made him angry and very moody. My grandson’s pulmonologist took him off the medication when my daughter spoke to him of the behavior changes. I’m hoping to soon have my grandson back. Poor baby, no one informed my daughter his mother that there could be negative side effects. You live and you learn but why do our children have to suffer for it.
On Friday,June 12, 2009 FDA acknowledged Singulair’s neuropsychiatric side effects:agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. (These side effects have also been reported in connection with Accolate and Zyflo).
The FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling).
The FDA advised that, “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.”
This is the link to the FDA communication, “Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)”:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165489.htm
Comprehensive information about Singulair is available at http://www.parentsforsafety.org.
We’re off Singulair now for three weeks. My daughter is almost three, had been on for two years, and experienced so many side effects that it’s too hard for me to type them.
Tips that work for us in coming off the medicine: treat your child as if they are hypoglycemic. As soon as my two year old gets out of bed in the morning, we give her scrambled eggs or something with protein and very little to no sugar. We continue healthy snacks literally every hour or two throughout the day. As long as she gets enough rest and her blood sugar is not given the opportunity to drop, she is doing MUCH better. This whole issue makes me more upset and sadder than I’ve ever been in my life.
OK-Im not usually one to jump on the band wagon or jump to believe media hype. My son started taking Singulair about 4 months ago (in the spring) for general allergies and enlarged tonsils and adnoids. The pediatrician who prescibed the medication is an asthma and allergy specialist. At the time she prescibed the medicationm, she mentioned the suicidal hype that was associated with the singulair. She stated that she felt that the information was associated with adults more than with children. She never stated anything about mood swings, behavior problems, etc. I went on my merry way and started giving my son the Singulair. Immediately we noticed an improved difference! However, over the summer, he has become more aggressive and has had huge outburst when he gets angry. He has started hitting, biting, pinching, and scratching when he is angry. I’ve had to pull him of of his 8 year old sister several times (he is 6). His fuse is very short and gets angry over little things. This has not been typical of him in the past–he’s always been very easy going. I’ve always had a few attention concerns so that was not an issue but NEVER any behavior issues. His teachers always say what he’s a very nice boy. Over the summer, I’ve mentioned to my friends that he has become a different child and I am worried about the next school year. What if he has this same outburst at school. He’s on a fast track for a behavior disordered classroom. I know because Im a therapist who works for a school district with kids with special needs! Anyway, after waking up for the 3rd day in a row of him screaming “I hate you, your a dumb fat jerk” to my husband (because he is being disciplined for hitting his sister), a light bulb went off and I thought, “This behavior started at the beginning of the summer around the time we started the Singulair, I wonder if there’s any correlation”? I got on the computer and started researching I found this website (and others). So for the nay sayers, I wasn’t looking for confirmation to a rumor–I never once thought that there might be any connection. I am just at my whits end trying to figure out why my generally happy 6 year old is now acting out so much! Anyway, needless to say, we won’t be taking our nightly dose of medication! Its not worth it!
i probably cant begin to describe how my daughter was horribly affected by singulair, but i definitely agree with all of the negative effects above. she was put on it at the age of 4 (right around when my motherinlaw passed away)…so i began to think her anxiety, clinginess and strange behavior was that she just didnt want me to leave her. she is now 10…this past year i succumbed to having to drag her into school and became best friends with the nurse and guidance counselor who often saw her in full panic attack mode and heavy breathing…whether she thought she was going to throw up, stop breathing or whatever it was that day. she has had issues with school since preschool..but got worse as the years went on and then one day while we were seeing a therapist she asked if we ever really looked into the side effects of any medicine she takes. so after reading the singulair message boards then i immediately took her off. within a week – i had a new child…which i now cry about and think how often in the past 5 years we fought and i told her how stupid and riduculous she was acting…i wish i would have known…i blamed her for things that werent her fault. but i am now sooo grateful for my little 5th grader who loves her friends, loves school and is always smiling…she goes to her girlfriends houses and doesnt need me to stay with her! i could go on and on…i am so thankful i have her back!!!
My husband forgot to give our 3 year old his Singulair yesterday and by the end of the night we were discussing how his behavior was so much better that day. We remembered hearing about “mood swings” and behavior problems as side effects with Singulair and decided not to give it to him today. We can’t believe the change in him! He has been on the drug since he turned 2 and has always been so difficult, exhibiting OCD characteristics and I used to say he was the poster child for ADHD. As an elementary vice principal, I was always perplexed by my son’s behavior and even more so because he was the complete opposite of his twin brother, who does not suffer from asthma or allergies. I am convinced, after all of my research, and seeing the results of my child’s behavior for myself, that Singulair should be pulled from the market! I am so excited to have my son back… and so is his twin brother.
I am so glad I found this website. My 11 yr old son has been taking Singulair since January of this year. Like other parents on this site, I too kept him on this medicine even throughout the summer months when he was allergy symptom-free. I noticed a small change at first, his arguments with his brother were a little more intense than they had ever been but I attributed it to growing “older.” Well, a few wks ago our allergist recommended he go to a GI doctor to try and figure out why he continues to get croup during the winter months. After this visit, my son became obsessed that there was something wrong with him. School started three weeks ago and he became extremely nervous and it has been a daily struggle to reassure him that he can handle fifth grade. He has always been a straight A, can-handle-anything-that-comes-his-way, never in trouble student. Yesterday, he told me he wished he could be happy again and does not want to worry about everything under the sun. Last night I looked at the Singulair side effects and immediately called his allergist who told us to take him off Singulair today. I am praying that he will revert back to my old, beautiful, funny, happy, loving son very quickly. If it truly is the Singulair that has caused this change in his behavior, then I pray it is something that can be undone without long term harm. Parents that have seen positive changes after removing this drug, thank you for giving me hope.
my 3 year old boy was on singulaire for a month and boy oh boy the behaviour was over the roof. we could not control him. i was so upset and did not what to do . no discipline worked and i did everything. i read about the change behaviour while on singulaire and is true. i realize naw that all that uncontrolable behavoiur was because of the medication. the doctor put him in singulaire again but after three pills i took him off( when i read about). i dont want to have the same nightmare again. he is a sweet boy and singulaire brings the evil in him. please do not give your child this evil medication
If you are concerned about Singulair’s mental health side effects, especially in children, please go to this website:
http://www.parentsforsafety.org/17601/10794.html
Also know that many of us are finding that while the worst side effects go away quickly, the aggression side effects linger for potentially years if not forever.