Aggressive behavior symptoms and conditions

SINGULAIR'S LABEL HAS BEEN UPDATED:

The following has been added to the "Precautions" section of Singulair's label:

"Neuropsychiatric Events
Neuropsychiatric events have been reported in adult, adolescent, and pediatric patients taking SINGULAIR. Post-marketing reports with SINGULAIR use include agitation, aggressive behavior or hostility, anxiousness, depression, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. The clinical details of some post-marketing reports involving SINGULAIR appear consistent with a drug-induced effect.

Patients and prescribes should be alert for neuropsychiatric events. Patients should be instructed to notify their prescribe if these changes occur. Prescribes should carefully evaluate the risks and benefits of continuing treatment with SINGULAIR if such events occur (see ADVERSE REACTIONS, Post- Marketing Experience)."

lupron makes me a bad person. i easily get irritated even on very little things. mood swings is very out of this world. i'm on my day 4 of lupron and i can't control my emotion anymore. i do deep breaths to try to control it but it doesn't work for me. i really have to shout my emotion or else i feel i will burst or die of heart attack. i don't know what to do anymore. i have to be relaxed to have a successful ivf. need your advice.

Last Tuesday, my son was prescribed Singulair by our pediatrician. He was also prescribed Pulmicort by nebulizer at the same time. Within a couple of days, I was noticing a dramatic change in his personality. He's only 21 months old and normally a very happy, lovable, easygoing little boy. He did a complete 360. By Friday, I had to take a day off from work, as I was too scared to send him to daycare. He took his last Singulair chewable tablet on Friday night. Saturday was his worst day by far. I was in shock by his behavior. He was extremely aggressive, punching and slapping anyone who came near him, he was throwing things, throwing himself into walls, etc, just completely out of control. I contemplated even taking him to the hospital, but then started doing some research online. I had my mother contact a pharmacist whom we trust, who advised for us to stop the Singulair, as if he was having any side effect, it would more than likely be from that. On Sunday, I started to see some changes in him. Yesterday he was getting back to normal. Today, he's that much better. We actually went back to the pediatrician this morning and I'm actually thinking of filing a formal complaint against the dr. as he basically swore up and down that his side effects weren't from the Singulair. Well as a parent, does anyone really think I'd want to put my child thru this?? It may be different if he had behavioral issues prior to this, but this came completely from left field. I am beyond upset right now, pissed off that this drug can be on the market. How many children have to be affected??? This is very scary to me. My son was only on Singulair 4 days, and I feel guilty and angry that he had to go through even that short period of time on the drug. And then to have a pediatrician basically discount me and say that it has nothing to do with singulair is a complete slap in the face! I won't stop speaking out against this drug and hopefully it will inform other parents of these harmful consequences!!!!

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.

My Dad has had colon surgery. Levaquin was prescribed. My Dad is 84. He was doing very well for several days, then went off the deep-end. He had hallucinations and aggressive behavior to name a few of many,many side effects. He thought they were trying to kill him. Unhooked all the intravenous and oxygen tubes and left. They caught him at the stairs. Had to sedate him and tie him down. My Dad did not know me nor my brother.

He has been off the intravenous drug for several days. While better, he is still working off the effects.

He has had many of the listed side effects, however, with the colon surgery how much is part surgery and part drug as far as nausea, stomach pains, bowel issues, vomiting, is a guess. However, he went from doing very well to a mess.

THE FOLLOWING IS COPIED DIRECTLY FROM THE SINGULAIR WEBSITE.....

The side effects of SINGULAIR are usually mild, and generally did not cause patients to stop taking their medicine. The side effects in patients treated with SINGULAIR were similar in type and frequency to side effects in patients who were given a placebo (a pill containing no medicine).

The most common side effects with SINGULAIR include:

stomach pain
stomach or intestinal upset
heartburn
tiredness
fever
stuffy nose
cough
flu
upper respiratory infection
dizziness
headache
rash
Less common side effects that have happened with SINGULAIR include (listed alphabetically):

agitation including aggressive behavior, allergic reactions (including swelling of the face, lips, tongue, and/or throat, which may cause trouble breathing or swallowing), hives, and itching, bad/vivid dreams, increased bleeding tendency, bruising, diarrhea, drowsiness, hallucinations (seeing things that are not there), hepatitis, indigestion, inflammation of the pancreas, irritability, joint pain, muscle aches and muscle cramps, nausea, palpitations, pins and needles/numbness, restlessness, seizures (convulsions or fits), swelling, trouble sleeping, and vomiting.

Rarely, asthmatic patients taking SINGULAIR have experienced a condition that includes certain symptoms that do not go away or that get worse. These occur usually, but not always, in patients who were taking steroid pills by mouth for asthma and those steroids were being slowly lowered or stopped. Although SINGULAIR has not been shown to cause this condition, you must tell your doctor right away if you get one or more of these symptoms:

a feeling of pins and needles or numbness of arms or legs
a flu-like illness
rash
severe inflammation (pain and swelling) of the sinuses (sinusitis)
These are not all the possible side effects of SINGULAIR. For more information ask your doctor or pharmacist.
Talk to your doctor if you think you have side effects from taking SINGULAIR.

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 3 year old son was having trouble with aggressive behavior in his daycare. The head teacher asked if he was on singulair. When he said he was, she said that that might be the cause of his aggressive behavior.

My wife went with my son to Chile for a month. The singulair prescription ran out while they were there, but because it had not been a month before the last refill before they left, they could not refill the prescription before leaving for Chile. The singulair ran out after their third day in Chile. So my son went a month without taking singulair.

And interestingly, his behavior did not change. He aggression was about the same as before. It is only recently, now that he has been developing more language skills and has also been potty training, that his aggressive behavior is for the most part under control. So in our case, it does not seem that there has been a cause-effect relationship between taking singulair and our child's aggressive behavior. He still takes singulair every day and is doing fine. Also, he never experienced any of the problems sleeping that others reported.

This past winter we found out that my son had developed asthma. His allergist /asthma doctor put him on Singulair as his preventative. Not two days later a report came across the news that Singulair has depression as a side effect. I immediately called my son's allergist / asthma doctors and was told that these symptoms have been found ONLY in children in their teens. That they are linking something in the med with hormones and it spawns depression.
Even though this is terrible for the parents of teenagers, my son is 6 years old... the chance of this happening to us was slim. Or so I thought.
One morning, to my horror, two weeks later my 6 year old son whom never really watched anything on television without his parents (with the exception of Noggin programs) is talking about how he wished he was never born. That no one would care if he was to die or disappear. That maybe he should just go to sleep one night an just die..... he was getting so angry for no apparent reason, throwing things and yelling all the time... telling me, his mother (we have always been so close) that he wished I were dead and that he hated me...
Needless to say I immediately called his doctors and they told me to stop the Singulair right away. The doctors were shocked that this has happened to a 6 year old and had filled out reports for the FDA that I had to give detailed descriptions of what happened to my son so they could start warning other parents.
Now, four months later and we have our happy go luck son back. No preventative, but the inhaler is doing the job.
Good luck out there if you agree to put your child on this medication. I understand it does not happen to everyone, I just cannot tell or describe to you how horrifying and traumatizing it was to go through seeing my happy go lucky son become this extremely depressed angry aggressive child within two weeks. We are still battling the aggressive behavior, but hey, he is 6 and that could be normal... right?

I am happy I found this website to express my concerns about singulair. My husband and I are still shellshocked about how singulair turned our lives upside down. My son was on singulair for 5 years. During that time he had extreme anxiety, nightmares, stomach aches, suicidal thoughts and tendencies, difficulty in school, aggressive behavior. We were at our wits end when we sought therapy at an anxiety clinic a year ago. He never went on any antidepressants or anti anxiety pills, just behavioral therapy. He went to therapy for approximately 5 months once a week. At the time he started therapy, I happened to switch doctors for his asthma due to an asthma flare up. He went to a pulmonology specialist at CHOP. He was taken off of singulair and put on other inhaler medications. Slowly, we began to see improvement in his behavior. I was holding my breath, thinking I was imagining his improvements and hoping his symptoms would not return. My son is now 9 years old and has been off singulair for one year. His horrific symptoms are gone and he no longer needs therapy. He is a happy, active nine year old. He had a successful year in second grade last year. I never realized it could have been singulair that caused his symptoms until I heard it on the news. His symptoms were always related to "behavioral problems". It was such a heart wrenching, frustrating experience because we could not figure out why he was behaving this way. My heart goes out to all the families who have experienced devastating symptoms. I contacted merck and the FDA. I want to contact my state representative. I am looking forward to seeing the results of the FDA study. I am curious how they are obtaining their data because I was never questioned about the details of my experience.

My son, who just turned 14 this month, was on Singulair for over 2 years.
He was diagnosed with reactive airway disease and possibly Asthma--and prescribed this awful drug-even back in 2004. The doctor said how wonderful this med was and prevents any further attacks.. So, for 2 years-every night, he took this mood altering, destructive drug. He lost all interest in school, his athletics-soccer, skateboarding, biking..in fact became almost a vacant , very unhappy, child-had stomach aches, joint pains and reflux--why--I brought him to the doctor and Pediatric center so frequently--all they kept saying his --his asthma is better, much be other issues...Even after the March 2008 suicide--his doctor said-that is just an isolated incident-just monitor him--It is a good drug. Right, month by month his behavior escalated to wanting to die, no reason to go to school-he said he was stupid and a failure and why don't I understand there is no reason to his life. A usually happy fun-loving boy -my son- didn't want to live. Nothing made him happy-I started to believe what the doctors said--maybe something or someone at school (bully, pedophile??) caused this change. Terrible nightmares and vivid dreams...Until this past July, I asked him want to go to the library for some books or dvd's...he went ballistic-threw everything off his computer desk and tried to break his chair. He is not an aggressive boy but this behavior was becoming a daily issue. Along with everything flying off his table, was his bottle of Singulair pills. It then dawned on me..I have been poisoning my only son. The child I know and love and gave birth to returned within a few days--although I am worried sick about further asthma attacks --all the doctors can prescribe is a steroid drug-asthmex or Pulmicort.. I cannot understand nor comprehend why this drug is being prescribed for children and young adults. The guilt I live with is terrible as my son has lost 2 years of his life--
and thought there was something really wrong with him-At least we woke up---in time--how about some other parents..thinking it's just normal adolescent behavior for their child or their fault???

My daughter who just turn 7 has been on and off Zyrtec for the past 6 months. This last time it finally clicked... She was on it for about 3-4 weeks and I notice her mood changed and she was now very angry at anything and started hitting her sibblings and throwing things at me out of anger. She also was waking up at night either with bad dreams, or couldn't sleep. My husband and I realized that this all started about the time we put her back on Zyrtec. Two days ago, I took her off it and the next day she was an "Angel" compared to before. WOW what a difference. I did notice today (day two) she was sneezing more and didn't feel as well physically. So we are not out woods yet.

She also has been taking Singular for several years and I have been reading more about that medicine as well. I am not sure if needs to be taken off that yet, and will do an experiment. The timing isn't the best since school starts in just two weeks, but it might be worth it to have a happy child again.

On a side note, last year in school, they diagnosed her as having social anxiety. She is "extremely" shy and closed off in school. It would take her hours to do her homework which should have taken about 30 min. I am curious if stopping singular would help clear her head and make her less anxious. (She was on Zyrtec as well during that time).

This would be such an answer to prayer if it works. My two sons are so much happier than my daughter and I always wondered why. This may be the answer!

My husband is being treated for a malignant brain tumor and uses dexamethasone to keep swelling in his brain down. Every time they prescribe more than 2mg/day he experiences irrational, aggressive behavior, violent mood swings and frightening bouts of rage. It is awful to live with.

My 7 year old son has been on and off singulair for a couple of years. He has been on it again for a month and we have noticed very aggressive behavior. He gets angry easily, nasty and into these rages where he actually is hitting me and slamming doors (even breaking the jam on his bedroom door!), just because he is not allowed to do something! After finding this site, I called the doctor(who of course did not call back yet) and took him off of the singulair. I am hoping the behavior gets better!

My daughter, just turned 3, was put on Singulair this past January for allergies. She had chronic runny nose, sinusitis, coughing, often leading to infections. The allergist put her on Singulair combined with Hydroxyzine every night. Now that I have read these postings, I recall that we had one really disturbing episode with her, although I can't now recall exactly how long after starting the drugs. Like some others have described, she woke in the night, seemingly terrified and at the same time in extreme pain. We could not find any way to soothe her or relieve her pain - she simply fought and flipped around, alternately reaching for us and kicking us away while screaming and crying and writhing on the bed. After a time, maybe half an hour, it seemed to just pass and she finally went back to sleep. But then we endured a couple of months of repeated wakings at night, sometimes when she was restless for an hour or more, sometimes upset. She might wake 3, 4, or 5 times in one night.

Lately I have become concerned about her increasingly aggressive behavior towards us, but recently towards others. And I am also very concerned about her physical growth. She is 41" and over 40 pounds and turned 3 a week ago. I am now buying her size 5T clothes. I have finally gotten proactive (why did I wait??!) and consulted with her ped., who has agreed that we should screen her for anything we can. My daughter has been diagnosed with developmental delays (pre-Singulair) and is in a preschool with similar kids. We have been dealing with behavior issues for the last year, and I am astounded that an allergist would put her on Singulair with the current controversy about it's side effects. I took her off it immediately as soon as I found out there were negative reports - thankfully our experience has not been as extreme as many others. But I feel ill at what could have happened! I am now praying that she has not suffered any irreversible damage...

Bless all of you in your struggles.

I would like to urge everyone to report adverse drug reactions to the FDA. Without a supporting data base, things move way too slowly and other people get hurt. I was doing some further work on quinolines/quinolones and ran across a medical researcher who starting writing about quinolones in 2001. The warnings that finally appeared on the quinolone drugs were placed in 2005. Let's do everything to keeping that from happening to parents.

Here is the researcher who wrote about quinolones so that you will have the reference.

******

My 13 yr old daughter was put on Singulair along with Asmanex and Clarinex for her asthma about 6 weeks ago. Everything seemed to be going very well at first and her symptoms were starting to get controlled. I started noticing after about 3 to 4 weeks that her temper and attitude were getting much worse. Anyone with children this age knows what I mean but this was like a 180 degree turn for her. Her actions were becoming totally out of character. Before I knew it she would cry and get highly upset over the least little thing. Week 5 came around and things totally bottomed out. She came home from school and WAS NOT HERSELF. Made comments about how she hated her life and it was not worth living. Later that evening we had a big argument because I was telling her nothing was worth saying that. She went totally out of control and I had to physically restrain her to calm her down. It appeared everything was better so she went to her room. I went down to check on her and she calmly told me that she had taken advil and tylenol pm and things would be better for her forever now. We went to the ER where they made us wait for at least an hour, then finally took her back. She had to drink two cups of charcoal and was poked and prodded repeatedly. They did a catheter to get a urine sample. She was very cooperative but also was in a complete daze so who knows. The poor child couldn't even lift her head up when she started the vomiting to get rid of the drugs. It was very upsetting and sad. Her heart rate and blood pressure went very low and I really thought in the back of my mind that this was it. Finally, after several hours she started coming out of it and they sent us home. The next evening when she was starting to really come around she proceeded to tell me how she had been seeing a man walking around in her bedroom at night and she was afraid to go down there. Breaking down and crying telling me about all of the horrible nightmares she had been having recently and didn't know why. I thought what am I dealing with here? This just isn't her. Three days ago I heard about singulair in the news and looked it up on the internet. OH MY GOD THIS SOUNDED LIKE US!!!!! I immediately had her stop taking it and the next day phoned her asthma specialist who agreed she should stop now. We are going to watch her for two weeks and see if any symptoms return and then decide if she needs something else or will be fine on just the Asmanex. As a side note, she also mentioned being unable to concentrate in school (unable to do even the simplest math problems) and that her brain felt confused or like something was missing. She said this had been bothering her for several weeks. I know it was this drug. They really need to take this off the market NOW and stop flirting with disaster. The only reason I posted this was to let others know they are not alone.

Unfortunately my lawyer told me that they do not want to take our case because of the lack of evidence that Singulair has caused our daughters problems. :(

Does anyone out there have a pending class action lawsuit that We may be able to get in on? I have tons of proof that Singulair has caused our daughters problems and loss of almost 5 years of her elementary school career!

My phone number is *** and my email is ****** if You email me please put "Singulair" in Your subject line so I know it pertains to this posting.

Thank You in advance,
Chuck & Brenda
Jamestown New York

Effective after two weeks for some people - not effective for others. Side effects for some people - others do not report side effects. So why does Merck have to grow their market before they have any idea what's going on?

This isn't a big group of people in the study but it makes sense from what we are reading here. These researchers did examine the mast cells. We need to know about mast cells (while suppressed by montelukast) on a longer term basis.

J Asthma. 2008 Apr;45(3):243-50. Links
The efficacy of montelukast and airway mast cell profiles in patients with cough variant asthma.Kawai S, Baba K, Matsubara A, Shiono H, Okada T, Yamaguchi E.
Division of Respiratory Medicine and Allergology, Department of Internal Medicine, Aichi Medical University School of Medicine, Aichi, Japan.

Background. Cough variant asthma (CVA) is characterized by chronic cough without apparent wheezing; its pathophysiology is considered to be similar to that of classic asthma. Objective. The clinical effects of montelukast, a cysteinyl-leukotriene receptor antagonist, on cough variant asthma were assessed, and the activation profile of airway mast cells was examined. Methods. Montelukast (10 mg/day) was given orally to 36 CVA patients (25 women and 11 men; median age, 37.5 years). Before treatment, the patients' bronchial mucosa underwent a biopsy with a fiberoptic bronchoscope. The biopsy specimens were double stained with anti-CD63 antibody and anti-human tryptase antibody. Results. After 2 weeks of montelukast treatment, cough symptoms improved in 22 patients (the effective group) but did not improve in 14 patients (the ineffective group); in the ineffective group, the symptoms disappeared 2 weeks after they were switched to fluticasone propionate (400 mug/day) inhalation therapy. In the effective group, the time interval from the onset of symptoms to the initiation of treatment was significantly shorter than in the ineffective group. The bronchial mucosa biopsy specimens showed that the proportion of CD63-positive cells in tryptase-positive mast cells was significantly higher in the effective group than in the ineffective group; although the total numbers of mast cells were not different between the two groups. Conclusion. There is a subgroup of CVA patients in whom leukotrienes are closely involved in the pathogenesis of their chronic cough; activation of airway mast cells may be an essential feature in these patients.

PMID: 18415834

I don't work for another pharmaceutical company. I don't have any competing interests. People keep asking me that. Why? Is everything about competition and money? I am getting sick of being asked that.

Frankly, I don't see how anybody could go up against all of the high powered lawyers that Merck can hire. If anybody wanted to speak about how this could happen, Merck would have people going through their doctoral dissertations looking for plagerism. Plaintiffs would have Merck detectives outside their houses hiding in the bushes. Merck private detectives would interview their friends and teachers.

All I wanted to do was to show parents and patients that they are not the only complaints. These complaints have been reported before. Whether they resulted in any serious warnings to Merck doesn't really make a difference because people know how they feel or how their child feels on Singulair.

There is nothing that we can do, in my opinion, but to believe in ourselves. We might trying writing to Queen Beatrix of the Netherlands that the American sufferers must have Dutch brains--which allow montelukast to penetrate the blood brain barrier and can she do anything for us? This is ridiculous that we should be getting these responses from doctors.

From the Netherlands 2006.
In three of the cases a positive dechallenge was seen.The fact that the patients (except for one) did not suffer from depressive symptoms before they started montelukast, the short latency, and recovery after withdrawal of the drug all strengthen our hypothesis that depressive symptoms are an ADR related to the use of montelukast. According to the Marketing Authorisation Holder of montelukast, depression will be added to the product information.

Mechanism: The mechanism of montelukast-induced depressive symptoms is unknown. However, montelukast has earlier been associated with adverse drug reactions such as abnormal dreaming, nightmares, hallucinations, agitation with aggressive behavior, irritability and restlessness, which suggests that montelukast can penetrate the blood brain barrier and exert an effect in the brain .

http://www.lareb.nl/documents/kwb_2006_4_montel.pdf.

I was just asked by Dr. ???, if these European reports lead to change in product information in these countries. I did post that I thought that we should try to find that out. I don't have access to that information. But I do see that the Netherlands did require that depression be added to the product information. It doesn't say the date but Merck agreed.

Artie wanted to tell us about the blood brain barrier. Where are you Artie?

The report says:

In three of the cases a positive dechallenge was seen.The fact that the patients (except for one) did not suffer from depressive symptoms before they started montelukast, the short latency, and recovery after withdrawal of the drug all strengthen our hypothesis that depressive symptoms are an ADR related to the use of montelukast. According to the Marketing Authorisation Holder of montelukast, depression will be added to the product information.

Mechanism: The mechanism of montelukast-induced depressive symptoms is unknown. However, montelukast has earlier been associated with adverse drug reactions such as abnormal dreaming, nightmares, hallucinations, agitation with aggressive behavior, irritability and restlessness, which suggests that montelukast can penetrate the blood brain barrier and exert an effect in the brain .

From the Netherlands 2006.

This is the html version of the file http://www.lareb.nl/documents/kwb_2006_4_montel.pdf.

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Nederlands Bijwerkingen Centrum LarebMei 2007Montelukast and depressive symptomsIntroductionMontelukast (Singulair®)is a leukotriene receptor antagonist available on the Dutchmarket since 1998. It is indicated for the treatment ofasthma as combination therapy forpatients with light to moderate forms of chronic asthma which cannot be adequately controlledby inhalation corticosteroids and short-acting ß-agonists. For asthma patients for whommontelukast is indicated as asthma treatment it can also relieve symptoms of seasonal allergicrhinitis. Montelukast is also indicated in asthma prevention, if exercise-inducedbronchoconstriction is the main factor

Reports On September 20, 2006 the database of the Netherlands Pharmacovigilance Centre Lareb contained four reports of depressive reactions associated with theuse of montelukast.Patient A is a female aged 55 who used montelukast 10 mg once daily for asthma associated with COPD. Concomitant medication included ipratropiumbromideinhalation, salmeterol inhalation, fluticasone inhalation, acetylcysteine, budesonide nose spray and desloratadine. Two weeks after montelukast therapy was initiated the patient experienced nightmares, a depressive symptoms, fatigue and increased dyspnoea. When montelukast was withdrawn, the first three symptoms resolved. It is not known if the dyspnoea resolved. The reporting pneumonologist stated that the increased dyspnoea also could be a sign of progressing COPD. Patient B, reported by a pneumonologist, is a female aged 39 who used montelukast 10 mg once daily for asthma. Concomitant medication included salmeterol/fluticasone inhalation, mebeverine and psyllium seed. One week afterstarting montelukast treatment the patient experienced chest discomfort, malaise,depressive symptoms and dizziness. Montelukast was withdrawn, patient outcomeis unknown. Patient C, reported by a pharmacist, is a male aged 46 who used montelukast 10mg once daily for asthma. Concomitant medication included omeprazole,salbutamol inhalation and budesonide/formoterol inhalation. Six days after starting montelukast treatment the patient got in a depressed state. The patient continued to use montelukast for four weeks but the depression did not resolve. When montelukast was withdrawn, the patient recovered. Patient D, reported by a pharmacist, is a female aged 59 who used montelukast 10mg once daily for mild to moderate asthma. Concomitant medication included mometasone nose spray, salmeterol/fluticason inhalation, oxazepam and paroxetine. Three days after starting treatment with montelukast the patient experienced insomnia and aggravation of her depression. When montelukast was withdrawn the symptoms resolved.

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Nederlands Bijwerkingen Centrum LarebMei 2007 Other sources of information drugs are known to cause depressive symptoms. However montelukasthas not been associated with depressive symptoms earlier . A Medline searchbased on the MeSH terms montelukast, leukotriens, depressive disorder and mood disorders did not yield any relevant publication. DatabasesOn September 20, 2006 the database of the Netherlands Pharmacovigilance Centre Lareb contained four reports of depression associated with the use ofmontelukast (ROR 2.1 95% CI 0.8 - 5.7). The same day the database of the WHO contained 3466 reports on montelukast, 43 of these concerned depression (ROR1.2 95% CI 0.9 – 1.6)MechanismThe mechanism of montelukast-induced depressive symptoms is unknown.However montelukast has earlier been associated with adverse drug reactions such as abnormal dreaming, nightmares, hallucinations, agitation with aggressive behavior, irritability and restlessness, which suggests that montelukast can penetrate the blood brain barrier and exert an effect in the brain .Discussion and conclusionLareb received four reports of depressive symptoms in patients using montelukast.Possible confounding includes that asthma itself has been associated with the development of depression . Inhalated corticosteroids can also exert effects onthe central nervous system. Fluticason in combination with salmeterol which isused by patients A, B and D, is associated with hyperactivity and irritability where as budesonide, which is used by patient C also has been associated with depression . The latency of montelukast-induced depressive symptoms variesfrom 3-14 days. In three of the cases a positive dechallenge was seen.The fact that the patients (except for one) did not suffer from depressive symptomsbefore they started montelukast, the short latency, and recovery after withdrawal ofthe drug all strengthen our hypothesis that depressive symptoms are an ADRrelated to the use of montelukast. According to the Marketing Authorisation Holderof montelukast, depression will be added to the product information.

Wow. I can't even express how blown away I am by all of this.My son is 7 and has been on singulair since he was 2. He was moved to the 5 mg last year in March. The only difference between my son and all of your stories is that when he was in kindergarten we discovered a rather large arachnoid cyst in his brain that had to be drained. It was easy to blame some if not all of his behavioral problems on the location of the cyst. It is in the left temperol lobe. Having something in that region of the brain can cause behavior problems. His cyst was also big enough to push on his pituitary gland making him think he needed to use the bathroom all the time. He had a slight case of diabetes insipidus. During all of this he was complaining of headaches, fatigue, leg pain, the boy could not walk from one end of the mall to the other, he would melt down at the slightest provocation and turn into an angry little monster at around diner time. We attributed it to low sodium levels messing with his head, but his blood work never reflected someone who was THAT bad. After his surgery he had some normal depression, but in March, four months after, he became a different person. He was full of rage and anger and almost got kicked out of school. He broke things at home and lashed out at people, he said awful things. He was put on Tegretol, (that made him very sick) and Wellbutrin. Since he couldn't tolerate the tegretol they switched him to abilify. He still takes this. The one time we tried to take him off he went completely nuts again. Same kind of aggressive behavior, lashing out, no self control, crying all the time, very moody, saying things like "nobody loves me." My son is the sweetest person you will ever know. Before all of this, he would melt your heart with his kind words. Now he has been diagnosed with ADD, Aspergers, and has all of one friend at school. I go every day to eat lunch with him so he doesn't have to sit alone. I completely understand that my son will continue to have problems once this medicine is out of his system, because he does have other issues, but this morning the first thing he said to me was, "Mom it's weird, I don't know why but I feel so happy."
He has been off the Singulair for 6 days now. I called his allergist and he was VERY interested in all of this and wants to meet with me. He has always been so heartbroken by how my son has struggled. Don't think all doctors are bad. This one isn't. He is going to help me report all of this. He is really upset too. Of course he is older, been around for ever. I don't know. He cares about his patients. His receptionist said she thought they would be getting a ton of calls about this and I was the only one. Hang in there everyone. Alone we are quite together we are LOUD.

I kind of think CNN and the FDA are intellegent enough to figure out that they should NOT get information off this website. What makes everyone think all these posts are real? First you have to weed out the pranksters who post here for fun, then you have to weed out the competitors to Merck who post here to bust chops, and then you have to weed out the ones who really have a psychiatric condition and get their jollies by posting made up stories.....shall I go on? This is the INTERNET people!!! Anyone with one, two or ten verifyable emails can sign up (I have 11 email addresses myself). I have been intrigued to see the same people posting under multiple user names. Then you go to the other boards and see them there. If you really study these messages you can figure them out. So my point is, NOT ALL THESES STORIES ARE REAL. I think I would be generous in saying 25% of these posts are legit. I would hope that no government agency or news agency is going to risk their reputation on a public forum message board.

Posting my experience again.

You are not alone and your children are NOT hypochondriacs (something tells me small children don't even know what that means).

My 5 year old son was diagnosed with mild asthma and put on Singulair. Within a few months he began having uncontrollable fits of rage, displayed self-loathing behavior, had night terrors, and was inconsolable during these episodes. He became very destructive and was a danger to himself and our family. He even talked about killing himself and would say things like "I don't want to be in this life anymore" and "I want to kill myself". He would threaten my wife and his siblings and told them he wanted to kill them. It was a truly terrifying experience. Our pediatrician was clueless to these side affects and recommended we have our child go through a psychological evaluation. I knew this was not my child's normal behavior so I searched the internet for Singulair side effects and found some message boards where parents just like me were telling their stories of their children's aggressive behavior. I immediately took my son off the drug and within a couple weeks he was back to his normal self. He told us that he no longer has "that feeling inside of him". Five year old children don't even know what suicide is and to see my son talk like this was extremely frightening. He is a sweet, intelligent, loving boy who had never exhibited behavior like this until he went on Singulair. We have not seen this behavior after taking him off the drug. Please use your best judgment and connect the dots for yourselves.

My 3 year old son had severe asthma and had been hospitalized several times. In May of 2007 he was given Singulair for his asthma. It seemed to work well and after his release he was taken off the meds. In October he became ill again and I told the doctor about how well the Singulair had worked. He started Singulair the first week he seemed to be doing great. But by the second week I started having aggressive behavior and became very restless. He was constantly acting out. This was a child who always was so sweet and kind. I started to question his behaviors, but because the medication seem to be working so well with the asthma- I dismissed it. Well by the end of the second week my son got very aggressive with my mom and collapsed and starting having a very violent seizure. He stopped breathing and ER was called. At first we thought the seizure was due to him being sick. He was sent home. The following week my son again had two seizures within 6 hours. This happened again the following week. No one could figure out the problem. I started thinking what had changed in his life over the past few weeks. The only new thing in his life was the Singulair. I started asking about the Singulair and the doctors agreed because the seizure's seems to come within a few hours of him receiving the Singulair medication. Singulair was stopped and the doctors and my family all agreed he was allergic to Singulair. Although the medication has stopped my son is still having the seizures and is now on two seizure medication. I know my son's situation maybe a little more severe than others on this site. I just think that this medication may not be good for children. It seems that it is doing something to the chemical balance in these children's brain. I am no doctor-but I do believe that this medication really needs to be further reviewed. Especially in the use of small children. I am just happy that my son is still alive. Everyone please do your research and be careful and ask questions before placing your child on any medication. Because each person reacts differently to drugs. It's just unfortunate for my son that he went from a child suffering from asthma. And now he is a child suffering with asthma and seizure disorder. And I firmly believe that this medication caused my son's problems.