Singulair and fda

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

POLL: If you or your child have been adversely affected by Singulair could you please reply to this and let me know what ethnicity you are and skin tone. (fair, med., dark, etc.) I'm interested in the demographics of this drugs effects.
Thank you!

I have been on singulair for several months or more. In the last month or so I have had a handful of breakdowns emotionally, crying like a little baby some worse than others. I feel paranoid but i don't know if that is just a case of anxiety.Leaving the house has become an issue if it is a bad sad feeling day. I just learned about an investigation tonight and googles it. It lead me here.

I don't know what to do.

My Daughter is almost 11 and has been on Singulair since the age of 3. She has some very serious signs of anxiety. I was never told of any of the possibilities of these kinds of side effects. As a matter of fact the doctor never discussed any side effects. I only know what I read on the prescription information almost 8 years ago. I am horrified to find out about this information. She has also been complaining for a very long time of spasms and pains in her legs which I have brought up to her doctor and he claims they are and have been growing pains. She came home from school the other day and was devastated over some bullying that had occurred toward her that day. I was heartbroken to listen to this from her knowing I cant be at school to protect her from this unnecessary garbage and at the same time was waiting for the 11 o'clock news on the singulair information. Now reading all of this, I am sincerely concerned about what is really going on in her mind after I watched her get up the next morning on her own at 5:30 a.m., ready by 6:00 in a full blown anxiety attack about going to school, and dreading going period. I will be speaking to her doctor immediately and I will be removing her from this prescription to see if there is a difference.

Along with uncharacteristic depression from using singulair for only a few months- I experienced ( and still now, after 1 week prior to ending my daily dosage) terrible lower calf cramps I have never experienced before. Not only do I get quick searing pains in my legs at night, but my calf muscles are very sore whenever participating in brisk physically activity. I hope these side effects will terminate shortly- because for an athletic thirteen year old high school freshman, depression, lack of energy and physical pains are not making the beginning of young adulthood a very enjoyable experience

My Daughter has been the same way .. she had the headaches, stomach pain, very depressed .. she has missed 6 months of school she was afraid to go to school, shopping, and being left alone.. I have put her on medication for her depression, and anxiety . i have her in therapy for this... she is not the same child i just want my beautiful daughter back..We are having a hard time with her from school to he social life.. and from her tring to kill herself.. My daughter is only 13 years old...I think someone needs to pay for this... please there must be help out there...How long must this go on before people (FDA, Merck, ALA, etc.) will take this seriously?!?!?!?!
I want my beautiful katelynn back........................
--

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 wanted to post an update on my contact with the Congresswoman's office , which I am communicating with.The ALA study we were all so upset with,was originally done by Merck,what a surprise!The FDA did contact me and state that they look at all the available data and have even reviewed this site.I am reiterating how important it is to contact your representative in Congress,they are trying to form a coalition for better notification practices.Our Congresswoman Kirsten Gillibrand is working with other members and looking for more to contact her office, that have families they represent.Also the Parents United for Pharmaceutical Safety and Accountability group that Jenna has formed is a very important tool.I will hand deliver it to Washington if we get enough people to get involved.The FDA is taking more time than we would all like but,if they have hired more staff and hopefully that alone will expedite this investigation along.I hope the awareness level rises when WBZT out of Boston airs our stories.Again Please Make a nuisance out of yourself with your Congress Rep. it will help to make it a law to expedite important information on added side effects to the doctors and pharmacist .All of us need to come togehter as one voice and it will make a stronger statement.When the advocacy website is up and running,we can all help by taking the time to contact those who have posted to sign up and get involved.The importance of this was stressed to me by the Congresswoman's staff.I also walked in a Suicide Awareness and Prevention walk over the weekend,I took the opportunity to hand out flyers I printed. They contained information on the serious side effects such as suicidal thoughts and actions, so people that may have had a loved one die from suicide and taking SINGULAIR could make the connection.Many have not made the connection and they are unaware of the link!!!!!!!
I am looking for all avenues to travel, any ideas are appreciated.I have scanned a print out of a sheet that is an alert to post in schools and emailed it to Jenna,if you would like a copy send me a private email and your email address.A family member worked with the School nurse in her hometown and made this a communication tool.You can start at that level and just white out the name of the town and the nurse add your own or nothing just the alert.We went to all the local schools and there is no liability it just states the facts,good for the bulletin board in community centers also!Do what you can to help,it is grass roots efforts that brought this country to what it is now.Even through disappointments we still have the freedom to try to make change.Kate M.

In September 2006, the National Academies Institute of Medicine released a report critical of the FDA and its ability to protect the public from unsafe drugs. In a section discussing the poor handling of scientific disagreement, the report mentioned the UCS survey result indicating that hundreds of agency scientists had been pressured to approve a drug despite reservations about safety

I just came across an article on the online "Huffington Post" by Dr. Doug Bremner, who researched the connection between accutane and depression, called "If Prescription Meds Don't Kill You They Might Drive You Crazy" He explains the link between Singulair, Leukotrienes in the brain and depression. There are numerous articles by him as well that are definitely worth reading.

Jenna M.
Parents United for Pharmaceutical Safety and Accountability

I have founded an advocacy group called Parents United for Pharmaceutical Safety and Accountability. The activities of this group will include supporting Kate and Dave Miller's efforts to initiate change in the adverse event reporting system and failed system of updated drug info notification to physicians and pharmacies, and to educate the public and motivate them to demand change too. Another activity will be to educate the public about the dangers of Singulair and how to spot adverse reactions. And finally, the biggie: putting pressure on the FDA to AT LEAST "black box" Singulair.

I personally wonder how many people out there have experienced adverse reactions to Singulair. At some point, if the FDA lets us down, I want the group to conduct its own study to determine this and maybe identify new adverse reaction?

Hopefully the website will go live next week. Anyone who wants to volunteer or give input is invited to sign up via a private message to me at this site. If you provide your email address I will contact you when the site goes live. If you would like to speak to me directly, send me your phone number and I will call you.

I have already contacted some of you directly, and if I have not yet gotten back to you, forgive me, I will.

Thanks in advance for any support you can give!

Jenna M.

IS THIS SITE AN ANSWER TO OUR PRAYERS?

A little while ago less than two hours, after a very emotional, difficult battle with my daughter, we had yet another heart to heart to try to do better. At the end of our talk WE PRAYED for guidance to know how to help the situation. So I'm here looking for a link to her behavior fron the ADHD medication and I see someone had posted about Singulair side effects. I was floored! I have never thought that Singulair was not a safe drug. No doctor has ever mentioned any negative side effects to me regarding it. The more I'm reading about it the more in shock I am. Have I and her doctors been doing this to my daughter? My 12 1/2 yo daughter has been on Singulair for probably 10 years. She was a 28 week preemie and had severe lung issues so it was a needed medication. Her behavior has worsened the older she has gotten. Because of mostly anger issues and problems in school about a year ago she was started on ADHD medications. We are currently trying to find "the right one" . I feel so awful. Could all her misery have been caused by this little pill that was suppose to help her? Why has her pulmonoligist continued to give it to her although she has not had any serious asthma problems in years? I think I will stop all medications and see what happens. My daughter has also been on amytriptylin for about six months also for severe migraines. What do you think? Should I stop all of them cold turkey or gradually decrease one at a time? I would GREATLY appreciate any advise.
Thank you

My daughter had been on singulair from the time she was 8 yrs old until she was 14. This will sound as if I am a horrible mother but I just thought that she was a raging bitch. Without my knowledge, she stopped taking her Singulair for a few months and she became a different person. She was so sweet and loving. One night she came in my room having an asthma attack and I asked her if she was taking her meds, she admitted that she had stopped taking her singulair and I got on to her and immediately got her prescription refilled. Within a few days of taking the singulair she turned into a raging, screaming emotional wreck, a TOTALLY different person. I feel so bad that for 6 years of her life I put her on medicine that caused her to have screaming, uncontrollable tantrums, and severe mood swings that caused her to be miserable. It does seem to be the only thing that effectively controls her asthma symptoms but the emotional havoc that is causes her and the people around her is not worth the benefits. We have an appt. with her doctor to see what other options we have.

One more thing:

It is imperative that you file an "Adverse Events Report" with the FDA. Insist that your or your child's doctor does as well. Doctors are NOT mandated to report adverse reactions of a drug to the FDA. The system is currently voluntary.

I think this fact is part of the reason it has taken so long for the truth about this medication to be revealed.

Also report your "Adverse Events" directly to Merck, Singulair's manufacturer. I believe drug companies are REQUIRED to report to the FDA.

I am wrong about these facts, somebody correct me please.

My 21 yo son started Singulair Aug.5 on Aug 6 he experienced an opthalmic migraine with persistent visual deficits that are constant. He only had one dose. He has never had any type of migraine before or even frequent headaches. Two neuro-ophthalmologists feel he is that rare case his vision may never be normal again. Singulair induced????

Hi Everyone,
WBZTV out of Boston interviewed my family this evening about our singulair experience. They seemed very interested in this story as it relates to how families and individuals have been affected by singulair and will be airing it soon....don't know the exact date yet. My son was able to say on camera that it made him feel "crazy" inside when he was taking singulair and that he feels "much better" since he stopped taking it. We told them we feel lucky to have gotten through our experience but there are so many others who have suffered and are currently suffering very badly as a result of the side effects of singulair.
I think the FDA and Merck now need to stand up and start taking some accountability for a drug that is admittedly "over prescribed". Doctors should be divulging the potential side effects of ALL drugs BEFORE prescribing it so the patient can be fully aware. I mean c'mon the warnings are on page 28 of a 33 page patient information pamphlet. Don't you think it should be on page 1? OK, maybe page 2.
They need to black box this drug. People have lost their lives to it and doctor's need to take their fingers out of their ears!

I just got done reporting back to the FDA the events of our "FLASH BACK" experience that took place last night.I asked how they can conduct an investigation when they don't communicate with the very people they are investigating,i asked how they can review old clinical trials that are at the very least 'suspect'.I do feel better i said these things but still fuming.Not expecting to hear back from them but hopeing

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.

I too filed a report with the FDA after I ended up in the hospital for 3 days after being on Singulair for 8 days. I never heard a word from them...never wanted to ask any questions, or follow up. This is crazy! People are having more than just "side effects" from this poison, and based upon the number of complaints here on this site, it's not just a few of us. I don't see how this can continue to go on. It is so frustrating...people are getting hurt, and dying from this stuff. How long must this go on before people (FDA, Merck, ALA, etc.) will take this seriously?!?!?!?!

I'm starting my first day today taking my son of Sinculair after reading all the post. I'm here because I was searching for answers as to why my son's legs were hurting all the time. He is on several medications and Sinculair being on of them.. Also in the past year he has been put on antidepressants, and now maybe I'm wondering if it's necessary at all that maybe it's been the Sinculair.
My son is 10 yrs. old and been using Sinculair for 3 yrs. I'll post back in about a week if I notice any changes.

Thanks for the update Kate,as we wait with interest in what Merck has to say,I hope it is not a repeat of the Lung Associations report.To review past clinical studies,i dont know feels crazy,to ignore post marketing reports,well ignorant.My fear is after making my report to the FDA,that was the end of it not one follow up for further information,not one question on how our recovery was continuing nothing.All my letters to my congressman not one reply,i did not ask for a reply,but if someone wrote to me as often as i write,i would at least want to rule out stalking.Clinical trials are what they are,they are for profit,and not the profit of the participant,but profit for the companies and clinics holding trials,this by itself is a conflict of interest.We must continue to demand change the very future of our children demands it.Those of us who have seen the ravages of this drug must still shout out till we are heard our experiences do count no matter what the out come of this investigation.Good luck to all keep fighting

Hey to All.
I know that the ALA study got everyone upset and I am happy we all emailed her.We all pretty much got the same response from Heather,defending the study and the integrity of the results.If only this investigation would conclude!
The Merck company contacted our Senator and indicated there was a conclusion and then ,they never got back to her before the weekend.I will have news early in the week.Please everyone just keep on voicing your concerns by reaching out any way you can.Sometimes it seems unbearable and I have to take a break with the communications on this website but,I continue my communication with my local contacts and the FDA.
I would love quick results and everyone would love this to get the publicity this story deserves but,if you look at how far we have come getting attention focused on this drug it is amazing.
This website has been here for years and people have complained and nothing has been accomplished until now.Our system is so broken it will take time to fix it.Drugs get approved everyday and when they are put out for multi use,the population benefit -risk ratio changes and there is little oversight on this matter.
The problem is much bigger than just notification of updated side effects,which indeed is why our son died from this drug.It is reporting adverse events to the FDA and the drug company and following up on your report.We can only fight within the system of the government that is in place at the moment and push for change to take place in there programs.
This is what has take place as of this year,The FDA's new 'Safe Use "iniative(which when it gets further developed will increase our partnerships with physicians as well as patients) and the July 2008 AAM report" Education in Safe and Effective Prescribing Practices" which aims to address the education of the next generation of physicians on how to best use medicines.This may help in notification practices and over prescribing but, we want the drug companies to lose the unprecedented control over the clinical research and and evaluation of there own drugs.What other company in the USA, gets to self regulate.Change will come ,we have asked for accountability by having a signature exchange when new and updated side effects are found.Full disclosure of all reported adverse events to doctors from the company representatives,with signature required upon full understanding of the benefit -risk ratio change. A prescriber should know all the good and the bad about a medicine they have chosen to dispense,if not then they should not be able to dispense it.If we were not knowledgeable about selling mushrooms and we sold the poisonous ones ,because we did not take the time it would take to educate ourselves about them,would we not be legally responsible for our actions.
Accountability is what we are asking for and maybe the candyland doctor prescribing practices would stop.They seem to ,not have a responsibility to their patients and the company has no responsibility to the prescribers,so who is responsible for our safety?
I will keep fighting for real change and all you people must do the same ,make an appointment with your representatives and have them contact our Congress representative of NY,maybe with enough onboard we can get the legislation we need to put a law in place for proper notification practices.Kirsten E. Gillibrand Member of the US House of Representatives 120 Cannon House Office Builing Washington, D.C. 20515
This is how change is made ,if you want to help please go forward and do this and don't stop until they listen.I am always willing to do whatever I can,it is physically exhausting and sometimes I just have to step away but, my daily review of this site has not stopped and my fight will continue.Dave and I sit here and our hearts just break for all but, we need people to push their Representatives they do work for the people just remind them of that.Any one with questions or that wants to communicate via private email just ask for my email address or phone number or leave me yours and a time and I will be sure to contact you,Kate M.

I'm going to be interviewed about my family's horrific experience with Singulair on Monday by a CBS news affiliate out of Boston. I am going to try and blow the lid off this story and will hopefully be posting my interview on youtube. This has gotten so ridiculous with the ALA "study" ....and I never wanted to go there....but it almost to the point of conspiracy. These people are just downright creepy!!!!!!!!!!

Just read an FDA article out today, I believe. The FDA is looking to publish quarterly a list of "potential problem drugs". That is fantastic! But where will this information be posted, and how often should a medical prescriber visit and hunt for such information?

I still maintain every medical professional with the appropriate credentials to prescribe any medication should be required to register with an email address with a database within the FDA to immediately communicate this new-found quarterly list, as well as any investigations launched (as with Merck/Singulair). Wow - what a concept.

I suppose I should be somewhat more optimistic with a slight move in the right direction - but I know with all my heart neither my daughter's pediatrician, nor my personal intern will receive, nor be aware, of any of the quarterly "lists".

Will keep trying to get a change within the FDA.

I just started Singulair about a month ago. Before I started taking the tablets I remember hearing some negative information on the news about the medicine. I found this web site and read about all the side effects before taking my first tablet. Even though there was so much negative information I thought I would give the medicine a try anyway. I have always been in good health and only needed this medicine for seasonal allergies. Part of me said "I know the side effects wont affect me!" Well I was WRONG! I have had the worst nightmares!!!

The nightmares started the first night I started taking Singulair. I continued taking the medicine hoping the nightmares would pass. Well, they have only got worse. However, last night was horrible. Not only did I have my nightly nightmares I had a hallucination! It started when I heard my 2 year old son wake up. He first opened his bedroom door then drank some water that was on his night stand, then was on his way over to my room. I got up to put him back in bed just to find out his bedroom door was closed and he was sound asleep in his bed. I haven't had any other side effects, but I think this is a good enough reason to stop taking the medicine. Does anyone have any other suggestions for another allergy medicine I can take. I've already tried Nasonex and Flonase they don't work nearly as good as Singulair. Any suggestions would be great thanks!

I read the article by the AP,what i find interesting is Mercks acknowledgment of some minimal brain crossing in rats of the drug....no studies were done in humans to see if it crossed the brain barrier....there is a way to find out if this happens designed by Columbia uni..fairly easy and inexpensive...and the FDA dosnt require the drug companies to do it What part of the big picture did they miss is this not a no brainer

I apologize that the summary is not ready yet. At this time, I am inclined to believe that the FDA will "black box" Singulair. Maybe, I am just hoping but we will see. I also believe that the FDA will also investigate the entire category of drugs with genetic components and warn doctors that these drugs do NOT behave AS EXPECTED when the patient has a genetic variant.

I am posting this again.

I just wanted everyone to know that I am still here and concerned about everyone who is having side effects from Singulair. Sometime within the next few weeks I am going to post a summary and conclusion about all of the research that I have posted. I hope to come up with a well organized concise statement about why everyone who experiences side effects from Singulair should stop using the drug immediately. Not everyone has an adverse reaction to this drug. For those who do, it is very dangerous to continue this medication even for one more day. STOP IMMEDIATELY IF YOU SUFFER SIDE EFFECTS FROM SINGULAR. WHEN YOU SUFFER SIDE EFFECTS FROM SINGULAIR, THE REASON IS THAT YOU ARE NOT COMPATIBLE WITH THE DRUG'S GENETIC BASED MODEL. Singulair targets the CysLT1 receptor, which is a gene. This gene is not the same for everyone. If your doctor does not understand that the mode of action of Singulair has a genetic component, then tell him/her.

My 6 y/o daughter has been taking Singular for approx. 2 years. She began to have regular stomach pains shortly there after. She was sent to Children's hospital where they put her on a laxitive which made things worse. Then we began testing for food allergies only to find out that she tested positive for a 3 page list of foods. We eliminated those food and had her tested again. She was subsequently allergic to the foods we eliminated. She was recently down to rice, a few meats and some vegetables. Guess what, she is now allergic to those foods.

All this time she has been complaining of severe leg pain, eye pain, throat pain, numbness and tingling in her hands a feet, all of which come an go. I have reported this to all the doctors and specialists we have seen. She had undergone countless blood tests to rule out autoimmune disorders and all come up negative.

She began to develop severe anxiety and just had the blues most of the time. She would be crying and saying off the wall things like, "I don't think my fish is happy". She couldn't stand to be away from me and would stress out about even weather or not she would sit by me at a restaurant. I mentioned this to all of the doctors. They said to not make too much of it. One suggested she see a psychologist. NOT ONE DOCTOR EVER LOOKED AT THE SINGULAR.

Finally about 4 weeks ago my neighbor who is a scientist at a pharmaceutical company called me and told me about the "black box" warning that had just come out on Singular. I took both of my children off of it immediately. My daughter went through about a 10 day period where her anxiety got worse and then it was just gone. We are adding foods back into her diet and at this point she has not had any severe allergic reactions.

The last 2 years have been a complete nightmare for her and for us. I am a medical professional and I have had doctors treat me like a hypocondriac, hypersensitive, attention seeking mother. I feel so justified and saddened by the recent findings all at the same time. Most of all I am so grateful that we figured this out before things go even worse.

Please let me know if anyone else is suffering food related reactions as a side effect.

I forgot to add my symptom of long bouts of sobbing to my earlier post. I took the advice from celticmoon and also made a report with the FDA. Here is the address: www.fda.gov/medwatch/report.htm

5 months Singulair free,yesterday was Matts first day of high school,his first day of regular school in 2 years as he could not leave the house or cope with out panic and fear.7am he awoke by himself and got ready for school,the only thing i saw in his eyes was excitement,he left the house smiling.While he was gone i passed and worried waiting for the phone to ring in case he needed me ,watching the clock and wondering how his day was. he arrived home at 2 thirty still smiling,i asked him how his day was he said fine, i asked him what they did he said nothing ,lol all is good ,thank you thank you thank you

SINGULAIR AND ZYRTEC SAME MEDICATION made by different companies. Be careful!

Hi to all,
I want to Thank all those who contacted me in regards to my request for help with the Media.I believe the reports are in now and the stories will be out soon.I am going to ask that if at all possible ,those that have contacted me wanting to come forward with your stories, let me keep your names for further reference if needed.If anyone does not want that, please reply and I will delete the information.I just cant thank all of you enough,you are helping many by coming forward with your stories.There is great power in numbers and every person counts that is willing to not lay down to this injustice done to our families.If you have a voice and use it, it is a tool to make a change.We all forget that years ago information was passed on by word of mouth,this maybe the only way this will get out until this investigation is over.Use every avenue possible and change will come.Thanks Again Kate and Dave M.

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

My son became soo aggressive 3 days after starting Singulair, that he was almost banned from soccer for life because of attacking another player on the field. It resembled what I had heard of 'roid rage'. When I questioned the doctor immediately, was told there was no connection. After months of the aggression, then came depression and self mutilation. My 15 yr old was secretly burning himself to 'punish' himself for things he done wrong or "disappointing" those around him. He now has permanent scars all over his arms from these burns. The depression took to drug abuse and my A student fell to an F student in 6 weeks. He completely lost his will to live and thrive. After 4 months of hell, the dr informed us that the FDA just warned physicians of this side effect. Im furious now that I read through the court documents and find that the drug company knew this all along. I know I am a luckier parent than some whose children committed suicide, but still wish that the FDA would get off their BUTTS and do something to take this drug off the market. I was told by a rep at the FDA that Merck will not take it off the shelf until they're made to because even if they had to pay parents millions for their child's suicide, they would still be pocketing more profit than our children's lives are worth in the court system. Not sure WHY we even HAVE an FDA, they won't do anything to protect us from these money hungry drug companies. A YEAR to do an 'INVESTIGATION" are you kidding me? If the CEO of Merck had to bury his child, it would come off the shelf THAT DAY.

Have been experiencing the same serious behavioral issues (screaming, launching every toy he has out of his room, knocking over his night stand, hitting, kicking and just being hateful) with my 4 year old who has been on Singulair for 2 years as I'm noticing many of you have here. My wife and I have a wonderful relationship and happy home and tons of love and support from other family that's close buy so the kid has a very nice environment. We have taken him off the medication as of yesterday. I have consulted his doctor but I'm anxious to hear what methods of treatment for the asthma all of have chosen in replacement of Singulair or did you just maintain with an inhaled maintenance program with something like Pulmicort? Also, how long was after taking your child off of Singulair did take to for the outburst to subside and the behavior to become more mellow and normal (what is normal for a 4 year old?). Any info would be greatly appreciated.

To all the Parents out there that are outraged at what Singulair has made your child and family suffer through - Please, please take a moment and file a complaint with the FDA. It is a simple form you can complete on the computer. This product should not be dispursed like candy to our children. It is amazing the number of doctors that are unaware of the severe side effects that this drug has. Our children suffer and we keep poisoning them under the illusion that we are helping them. We tend to blame the abnormal behavior on growth all the while punishing them for it. It is a horrible, horrible cycle.

I am a parent of a 14 year old son. He has been on many meds due to having migraines, adhd, seizures, and asthma. For 3 years his ADHD meds have been switched. Now Thanks to a friend she told me about singular side effects. OH MY GOD. it blows my mind reading this stuff. He has been on singular for 3 years and never once did I think all these problems were caused by that drug. Flipping out over the smallest things, arguing with us his parents, his friends, being mean to us and a real smartass, depression, and MAJOR attitude. Getting upset over nothing at all then crying for no reason What was his Dr. thinking? Needless to say, I took the singular while she was telling me this stuff about her own son, and threw them away, I will never allow my son to take that shit again. I hope in three days like all of you say, that my son will be that loving, caring, friendly person he use to be ! Singular free is how he will be!!

unfreakinbelievable. every single drug ad I see on TV these days for new drugs claims that it will cure you of something. the only catch is: it will give you a million side-effects, half of which can be life threatening!!!

What kind of a job is the FDA doing that it lets these kinds of drugs enter the market and puts people with common problems like asthma in greater danger for developing extreme heart problems and psychological disorders???

I used Reactine. The very 1st tablet I used gave me a dream so vivid that I jumped out of bed - I was about 30% conscious and I still believed that I was in that dream. I dream that a Black Widow was in my bed right under my back and when I woke up I actually envisioned the Black Widow. Now consider that I live in Canada where BW's don't even exist. That's how powerful these drugs are and that's why you should stay away from them. I know this sounds crazy, but DON'T BELIEVE A THING YOUR DOCTOR TELLS YOU!!!!! Use common sense in common situations!!! Think for yourself and listen to your gut instinct or you will wind up dead before your time.

Hi to all,
I wanted to take a minute to say Thanks to all who post and search for answers to this drugs confusing and serious side effects.To all who have taken the time to contact the FDA and file a report to help others.Dr.Sarah Sellers is no longer the person to contact at the FDA,she has moved on after concluding her end of the investigation on Singulair.If you have a serious side effect please still take the time to file on the official FDA site for adverse event reporting.In NY. state we are still searching for legislation to help with the notification process for these serious side effects.There are to many Doctors that still do not have a clear idea of the updated side effects,and are not reporting as they should.
Letting your doctor know that good medicine is all about follow up on complaints,such as researching the singulair website to rule out that it may be the drug or it may not.Just dismissing the patient and prescribing another drug is how these drugs go undetected for so long.We want this to stop and only the unfortunate recipients of the horrors of this drug can make this happen.Again thank you for your efforts to change the system with follow through and perserverance.Our horror story is one of many and we want to help those who have survived the ravages of this drug, OUR CHILD DID NOT. Kate and Dave M.

My eight year old daughter was recently diagnosed with precocious puberty. This is devastating to my family...She was on singulair fo asthma for almost 4 years...Noone in the med profession will comment on how this happened but the internet is filled with other parents dealing with the ame dilemma. I am so furious right now.

Singulair associated with Churg-Strauss. A study in France and Germany.

Thorax. 2008 Aug;63(8):677-82. Epub 2008 Feb 14. Links
The leucotriene receptor antagonist montelukast and the risk of Churg-Strauss syndrome: a case-crossover study.Hauser T, Mahr A, Metzler C, Coste J, Sommerstein R, Gross WL, Guillevin L, Hellmich B.
Dr A Mahr, Department of Internal Medicine, Hôpital Cochin, 27 rue du Faubourg Saint-Jacques, 75679 Paris Cedex 14, France. alfred.mahr@cch.aphp.fr.

BACKGROUND: There has been some concern that leucotriene receptor antagonists might precipitate the onset of Churg-Strauss syndrome (CSS). A study was undertaken to investigate the relationship between the leucotriene receptor antagonist montelukast and the onset of CSS. METHODS: Medication histories of 78 patients with CSS from France and Germany were retraced by questioning the patients, treating physicians and dispensing pharmacists, and from medical records. Using a case-crossover research design, exposures to montelukast and other asthma medications during the 3-month "index" period immediately preceding the onset of CSS were compared with those of four previous 3-month "control" periods. Odds ratios (ORs) were computed by conditional logistic regression. RESULTS: The ORs for CSS onset were 4.5 (95% CI 1.5 to 13.9) for montelukast, 3.0 (95% CI 0.8 to 10.5) for inhaled long-acting beta(2) agonists, 1.7 (95% CI 0.5 to 5.4) for inhaled corticosteroids and 4.0 (95% CI 1.3 to 12.5) for oral corticosteroids. Montelukast exposure during control periods increased temporally over three consecutive calendar periods of CSS onset from 1999 to 2003 (p(trend) <0.0001). CONCLUSION: Montelukast use was associated with a 4.5-fold higher risk of CSS onset within 3 months. However, the positive estimates obtained for other long-term asthma control medications suggest that this link might be confounded by a general escalation of asthma therapy before CSS onset. The association between montelukast and CSS observed in this study is probably also explained by the increasing use of this medication over time.

PMID: 18276721