Singulair suicide side effects to be reviewed by FDA
The FDA has released a statement regarding their investigation into a possible association between Singulair and suicides, suicidal thinking and unusual behavior changes. The drug regulators have requested additional information from Merck & Co., the manufacturer of the popular asthma medication, and they expect to complete their evaluation of the Singulair suicide side effects within the next nine months.
>>FDA Early Communication: Singulair Suicide Investigation
Singulair is a pill approved by the FDA for treatment of asthma and allergy symptoms. The medication works by controlling chemicals that are released during allergic reactions which may lead to inflammation, congestion and other allergy symptoms. In recent years, it has become one of the best selling medications in the world, with total sales of $4.3 billion in 2007, about three quarters of which came from prescriptions in the United States.
Since last October, the FDA has received several reports of suicide among users of Singulair, as well as other reports involving severe mood changes and suicidal behavior. Within the past year, Merck has added indications to the prescribing information about Singulair side effects which indicate that the drug could be associated with tremors, depression, suicidal thinking and anxiousness.
The FDA has requested Merck go back through adverse event reports received by the pharmaceutical company to take a closer look at the data. The agency will review available information to look for reports of behavior and mood changes, suicidal thoughts and suicides among Singulair users. After they have completed their review, the FDA will communicate any conclusions and recommendations to the public. This could include stronger warnings, restrictions on who can receive the medication or no regulatory actions at all.
Singulair is part of a class of medications known as leukotriene agents, and other similar medications in this class include Accolate (manufactured by AstraZeneca) and Zyflo (manufactured by Critical Therapeutics). As part of their review, the FDA will evaluate whether any suicide risk with Singulair may also be associated with Accolate, Zyflo and Zyflo CR. However, those medications have been taken by a very small number of people when compared to those who have been prescribed Singulair. The combined sales of these other medications in the U.S. was under $70 million last year, compared to $3.4 billion for Singulair sales in the U.S.
While the FDA continues their investigation of the Singulair suicide side effects, they have cautioned doctors to carefully monitor patients taking the drug for mood changes and signs of suicidal thoughts. The FDA has indicated that the early communication does not mean that there is definitely a relationship between Singulair side effects and suicides, but reports received have led the agency to take a closer look at this emerging safety issue. There is no indication that users should stop taking the medicine, and no prescription drug should be discontinued without first speaking with your doctor.
SINGULAIR SUICIDE LAWSUITS
The lawyers at Saiontz & Kirk, P.A. are closely monitoring the FDA’s investigation into the possible Singulair suicide side effects. If you, a friend or family member have suffered severe physical injury or death as a result of a suicide or suicide attempt while taking Singulair, review the legal options which may be available by requesting a free consultation.
Our 10 year old son was diagnosed with an anxiety disorder by a psychologist pursuant to taking Singulair and we can document the connection. I am a civil litigation assistant for a small firm in Iowa and would be willing to serve as a lead plaintiff should there be any action pursued against Merck for failing to disclose the potential side effects of Singulair.
I have not had physical harm or died because of Singuliar, but while I was taking the drug for my asthma I had mood swings and was not an easy person to get along with. Which effected my school and home life with my parents.
My brother was on Singulair from June of 2002 until his suicide in June of 2004. Fine one day, and gone the next.
I think you all need to stop jumping to conclusions with baseless lawsuits.
In clinical trials, only 1 patient attempted suicide in the singulair group, whereas 3 patients did so in other asthma medicine groups. This was studying over 44,000 people in each group.
So just maybe, the suicide had to do with the person and not the drug. Sometimes people need to own up to what they did and not seek to blame it on anyone they can for a cheap buck.
I was an easy going person who was really easy to get along with and always relaxed before starting on Singulair. Afterwards I became a depressed monster with violent uncontrollable mood swings, I would cry during any and all arguments that I had, I thought life was completely hopeless, and put a gun to my head on several occasions contemplating blowing my head off and ending it all. My wife told me something was happening that was changing me because she knew that this behavior just was not me and I even starting seeking counseling for it. Luckily my wife was there to snatch the gun away from me and hide it whenever it got really bad. I treated my wife and my children so bad and now I’ve lost them. I’m off of the singulair now and starting to feel like my old self again but it’s too late for my family. My wife understands that this medication is likely to blame for this but says although she loves me very much, she just can’t get past the way i was on singlair. My life has been ruined and I’ve lost the most wonderful woman, beautiful daughters, my job, and my house is currently in foreclosure. I had to lose all of this just so that I could breathe a little easier?! Thank you Singulair! Thank you so much!
In February 2008 I was prescribed Singulair. I started to get mood swings and a deep depression. I was getting ready to go to the doctors and say I have a problem and I may need to take something to help stop this. It was then I saw the news report. I stopped taking the Singulair. I went through and I am still going through horrible withdrawals from this medication.
I already suffer with panic attacks and this has been amplified by my ordeal with this medication. The doctor who prescribed it has never called to see how I am doing. I have told my regular doctor about the problems I have had with this medication, I have even told the hospital and yet no one has helped me with getting off of it. I have stopped taking it slowly. On Monday April 7, 2008 I was going to take another dose to help but my withdrawals from the previous dose were so bad, I chose to ride it out.
On Wednesday April 9, 2008 I passed out at the stove burning my hair and getting a mild concussion. On Thursday April 10, 2008 a panic attack turned into a run with another injury causing more to the concussion and a bruise over the right eye. I don’t know the relation of these episodes and the Singulair. I am still having the cold sweats, the nausea, the depression and mood swings from this drug. My sedative is what I take to help keep me calm.
This is a horrible medication. Not only should MERC be held accountable but also the FDA and those doctors to arrogant to do their own research.
Medication that are tested properly are good for us. Those that are sent out just for profit, that is when those who send it out need to be held accountable.
We are not guinea pigs, we are human beings. I for one am tired of being messed with by a corrupt, uncaring and greedy system.
I have been on this medication for 7 years and my quality of life has completely changed. I went from being a productive person to just a severely depressed, moody, having tremers, shakes the whole nine. I spoke with the doctor and we are asessing the issue.
My 8 year old daughter has been taking singulair for 4 years due to allergies and asthmatic syptoms. She has been diagnosed by a psychologist with anxiety and depression. She also has alot of “mood swings” for an 8 year old. If Merck and Co. knew about this and let peditricians prescribe this i will fight to the end!!! I have taken her off of the medication, and i am hoping to see an improvement.
i joke with my girlfriend calling singulair “my angry medicine,” she doesn’t think it’s very funny though. about a half hour after swallowing the pill, i am more angry and more irritated than ever for absolutely no reason. i’m typically a very calm guy but this medicine makes makes my mood very mad, i just can’t control the anger i feel, i never feel or have every felt that way except when taking singulair. i have been taking it for about a year but only once or twice a week (when i get stuck being around animals) the asthma relief it offers is good but the psychological effects are horrible. i couldn’t imagine taking this medicine everyday. i’m sure it screwed a lot of people up for life. it must take a huge toll on body and mind.
My son is 11 years old and has been on the adult dose of singulair since 2005 and just until recently after hearing of the side effects of Singulair was I able to connect his severe anxiety and depression to the medication. He has suffered for over two years and continued to take Singulair for his asthma and allergies even after I asked his doctors if there was any link after he started showing symtoms of anxiety and depression at the age of 9. My son has been off the medication for two weeks now and is somewhat better. He has not expressed the thoughts of hurting himself, wanting to die, or has sudden bursts of crying for no reason, or nightmares. I am also willing to attest to what kind of horror is has caused my son as well as my family for the past couple of years. I just hope that he does not continue to live with anxiety, fear and depression for the rest of his life.
My 14 yr old son was on singulair for three and a half years,after two months on singulair anxiety and saddness set in,a year and a half on singulair severe depression to the point he was hospitalized,lexapro wellbutrin celexa all useless against it.A complete withdraw from society,only home schooling as he could not survive the pressures of life,two months off singulair and my happy boy is back but the life he lost irreplacble.
When my daughter was 3 or 4, she was prescribed Singulair for her chronic ear infections. The doctor said that it would help to drain the fluid from her ears caused by allergies. She was on the medication for a short period of time when I noticed that she was having severe mood swings. She would be happy one minute and crying the next. She was extremely irritable and she started being very mean. I stopped the medication and called the doctor because this was alarming me. He said that he hadn’t heard of any side effects like this, but to stop the medication anyhow. She is 7 now. I still deal with sudden mood swings and bursts of anger. I am not sure if this is a long term effect or not. But she was a normal little girl before she started the medication.
I have been taking singulair for asthma for about 8 yr and my son for 5yr. Neither one of us have had any problems with either depression or anxiety. I can certainly testify to improvement of our asthma symptoms. Only rarely now do either one of us have to use a rescue inhaler of resort to a nebulizer treatment.
I have two children on sinulair my 12 year old was put in residentual in Nov. for her behavior and she is still on sinulair, my son is 13 at home has anger, mood swing every thing else they are talking about starting him on lithum he still takes sinulair thanks for your help. Its out of here and fast.
In march of 2007, I started taking singular due to my doctors advice. I could only handle taking two doses. After the second dose, severe insomnia and anxiety set in. I had to go to urgency care. The doctor put me on anti-depressants and sleep aid. For 4 months, I was on 6 different types of anti-depressants and 3 different types of sleep aides. I had to resign from a good paying job and lost my insurance. For the past 19 months, I cannot find any help and constantly struggle with anxiety and insomnia. Every time I have to deal with a stressful situation, my anxiety is very intense and very overwhelming. When nighttime comes around, the fear of trying to sleep, and falling asleep is excruciating. God bless Merck!!!!
I’ve been taking Singular for over 2 years, and have been experiencing all of these problems with anxiety and increased aggression. I have very difficult time controlling my asthma, so I was depending on this medicine to help me. Finding out it may me the cause for my frequent recent visits to doctors for these same issues, is upsetting. I feel cheated, and disturbed. I have been feeling much better since recently changing asthma medicines.
My daughter who is now 14 has been on Singulair since she was 7 or 8, as she age we started experiencing problems. Sad to say we thought instead of God sending use our child the devil had sent us his seed. In public she was melt in your mouth butter but at home we lived in terror. A brush against her would result in a verbal argument , slamming doors and often hand to hand combat. It is like she was a ticking time bomb you just didn’t know what would set her off. My husband and I thought teenage hormones until she began to burn and cut herself. She would physically take on hers sisters in fights. One night because someone had left her blinds open she tore all the curtains down thru out the house. The next day she ran away we found her almost in Memphis. She has since then burned her flesh with matches and cut up several out fits. When she’s not having a fit she asleep to everybody relief. We today I acknowledged something was wrong and we went to a mental facility where I encouraged her to talk but before I went I sa down at my computer and typed in all her medications she use for asthma some of them were scary but not as scary as Singulair . She said she has not had suicidal thoughts but getting into strangers cars to run away seems to be a suicide attempt to me. We go to the pediatrician to have her meds changed pretty soon
Prior to singulair, my daughter was a happy, gentle, easy going child who rarely got angry or upset about anything. She took singulair for a little over a year for her asthma (prescribed by her pediatrician) at age 4 and her behavior changed drastically. She would have night terrors every night, very vivid nightmares, wake up screaming. She began throwing violent tantrums, put her fist through a glass window (called for ambulance), got thrown out of two daycares for violent behavior, had problems in school (throwing furniture in kindergarten) etc… I had no idea it was the singulair that was causing her behavior until I by chance googled singulair and aggression and got a number of hits. I took her off of the singulair and the nightmares went away, however, the aggressive behavior did not. She took the singulair for a little over a year. I have been battling her physical and verbal agression for over four years now. She has now just recently been diagnosed with pediatric bipolar at 8 years of age and will have to take psych meds and deal with this illness for the rest of her life. I know the singulair triggered the bipolar and ruined my daughters life. She had none of these behaviors at all before she started taking singulair.
My son started taking Singuliar at age 5. Within a year, he was talking thoughts of suicide, at age 5! To make a long story short, he went on medication for ADHD, Depression and Anxiety at age 7. Went through psychiatrist and therapist up til age 11. It always seemed we couldnt get the right dose or medication to get him “leveled out”. Finally at age 11 my husband and I decided to stop all psyciatric meds and therapy,they werent making any difference. He seemed to be the same without. A year later, we decided to see if he had outgown his asthma, he was having no flare ups nor needed his inhaler. At age 12 we took him off his Singulair. What a difference. Even though hes a teenager now (14), he is more stable with his mood, no more mood swings, no more angry outburst, no more talking about suicide. (These all lasted from age 5 til 12) I truely believe that Singulair was the culprit to his “psychological problems”.
My 3 year old has been taking this for over a year. We have been complaining of mood changes, severe sleep disturbances (which they have done two sleep studies for thus far). Her mood has gotten worse, shes become very aggressive. He sleep disturbances have also gotten worse. Constant sudden awakenings, body tremors, even documented wimpering and agitation during her sleep, body jerking (enough to fall out of bed), etc. The specialist printed a copy of the FDA warning and told me to talk to the Peds. She has decided with her moods (aggresion) and severe sleep disturbances getting worse to change her meds. Yes, she is only three, but she has been taking at least a year and she has gotten bad. You would think a doctor would have told us by now with us constantly telling them something is wrong she isnt herself.
Sorry had to vent. Its been bad and couldnt figure out why her personality changed.
My daughter has been seeing psychologists for anxiety, depression, and possible hallucinations for a year, she has been on singulair since she was a child, last year she was also prescribed VyVanse which has the same side effects. She was also diagnosed with ADHD. Last year she smashed mirrors and refused to go to school
Last week I had asked to increase her singulair due to worsening asthmas symptoms, then I was told it could cause depression by her Ped, well Hello, why didn’t you tell me that earlier before you sent me to the shrink?
I took her off both the Vyvanse and the singulair last week, and I am happy to report she has not talked back to me at all, has not heard music in her head, has apologized to me, got A’s on her report card, and has not cried once since! I can’t beleive I was thinking she might be Bi-Polar! I am really angry that I went through all of this, and not One psych professional(there were 3)nor one pediatrician(there were 2) even thought her meds were contibuting to her mood swings! They call themselves professional, I would like to sue them!
Also I had to switch schools, because I thought it was her school environment! How crazy! My poor daughter!
I took Singulair for Asthma. It helped me breath but it also made me mad as hell, for no reason. It gave me bad insomnia and I would think about suicide. I gained a bunch of weight on it as well. I also had the same reactions on prednisone. I took singulair for about 6 years. Once I stopped taking it, I felt so much better. It did it’s job of helping get my asthma managable, but I was a horrid person to be around when I was on it.
I took Singulair for three weeks this Spring. I tried twice to quit taking it , but I would feel nervous and jittery. I stopped it completely March 19, 2011. Within two-three days I felt nauseated. I could not eat, loss my appetite, and went into a Severe Depression. This medicine messed up my nerves and stomach. I teach school and had to take a leave of absence. My symptoms were awful. The nerves were burning all over my body for 3 weeks. Then I had anxiety all over my body for at least 3-4 weeks. I am on an antidepressant and an anti anxiety medicine. I still have some depression and anxiety. This drug should be banned.
I was put on Singulair 5 years ago after allergy shot did not work. I thought wow…I dont have to take my inhaler around. I found a great woman to marry and sometime into our courtship I would have anger outbursts which are totally out of character for me. If stressed I would shout at the top of my lungs and slam doors, and in the midst of it make pictures fall off the wall or break light switch plates. It would take a day or two to come out of it. It would start all over again the next week. I thought I had an anger problem and if my wife were not who she was we would be separated by now. I tried to examine every area of my life to explain this. To make this long story a little shorter, I take 1/2 the dose -1/2 a pill now. No anger problems. I wish I could have the time back this drug stole away from my marriage. Although I have no asthma symptoms and the anger issue is gone, I have baggage and have to live with the notion that I ‘had’ a behavior problem. This drug should be extremely carefully monitored and not be prescribed frivolously.
I have relatives who take this drug daily and now they have anger problem, an out of control problem plus physical problemss. They are ages 4, 6 and 8….. the parents are clueless and refuse to listen. After all, their well known pediatrition recommnded it. The kids just need to get under control of themselves. It is not the kids fault….it’s the drug, parents! A horrible one at that. Sue the pants off of Mercke untill they take it off the market. It’s dangerous. Parents wake up. Be your kids advocate. Doctors don’t have a clue about the dangerous side effects and don’t care. Big Pharma is all about making money not caring one iota about our kids. Try Hyland products… homeopathic with NO side effects. They work better than the scripts.
PARENTS BE WARNED i have been having Terrible problems with my 5 year old son head aches sore joints not sleeping well hypersensitive frustrated fighting lazy eye worse weeing heaps drinking lots not so active cries alot yells tummy pain brain telling him things and the list goes on .very worried thinking something is very wrong we went to doctors and specialist and many tests and hundreds of $ to be told we need counciling.THEN A mum from school worked it out its his ashama meds SINGULAIR doing this we have now stopped it and my little boy is slowly getting back to his self and his school work in one week off the meds is 100% better
damm pharmaceutical companies there is no warnings on the box PARENTS BE WARNED ITS TOXIC DO NOT GIVE TO YOUR CHILDREN i cant wait to have my little man back to normal i just cant belive how much it did effect him,and our family .i had a break down and my daughter suffered to. ,please pass this on xxxx
id like to add to my above post it also explains the hundreds of questions about death like mum if i jump of there will i die or mum if i run in front of a car will i die etc etc its only just dawned on us that this to has stopped since we stopped the tablet OMG TOXIC STUFF
This allergy “medicine” was perscribed for my son by what used to
be our doctor. Careless pill pusher. I am so mad. My 17 year old was
on it for a month and a half. Within 2 weeks of Sigulaire he had a car
accident because what he saw wasn’t accurate. He could have been
killed. My son was a wonderful driver. He has had horrible mood swings,depression,insomnia. and anxiety ect. This “medication” is no
joke and should be banned. Shame on Merck and the “doctors” who
prescribe this-they should be held accountable for the damage they cause to the unsuspecting public.
My daughter ( 27 ) has been taking this drug Singulair for about a year. It has helped her asthma. But she has also developed horrible depression & now takes Zoloft & Trazadone for these new symptoms. About a month ago, she had been struggling with bronchitis and anitbiotics were not working. The doc that was treating her ( without any X-rays ) decided she had cracked a rib from coughing so hard. Mind you she kept telling him she was having horrible chest pains. He sent her home with vicodin for cracked rib, said to “rest” and let the anitbiotics do their job. This was her 3rd round of antibiotics and she kept getting sicker. So I took her to the ER, and it was like a whirwind. Within minutes, they knew something was going on with her heart. It was beating over twice the normal rate. So, then they find fluid around heart. Then they find 45% Eosinphils in blood & in Fluid. ( normal percentages for this type of white cell is 1-4% ) The doctors said they were shocked that she was walking, let alone breathing in her own. They had to cut a 4 in hole in her chest, insert a large chest tube and drain the fluid. She had the tube for about 3 days & drained 500 CC of fluids!!! Now they are saying she has Chrug- Strauss syndrone, which is a serious lung disease that is inked to Singulair. The doctors will not admit Singulair did this to her. But she spent 4 days in ICU, & then another 4 days in hospital. She had a 24 hr period where she almost died. This drug needs to be recalled. There are way too many people being seriously injured due to the side effects. My kid is only 27 and now they say she might have this Chrnoic Lung disease forever. This is no cure for it!
I was on singulair for a very longtime when I look back at the time when I started taking it I had alot of suicide thoughts even attempted suicide by taken paxil and night quil in large amount a friend took me to er but I left on my own, my mom had to come to my aid because I was so suicidal , mood swings and breakdowns and yet I was put on paxil and still had the same feelings. I had asthma and that is why I was placed on this medication. I then started having terrible nightmares now known as night terrors. I would wake up feeling like I was gonna die and fighting and screaming my family and children witnessed this. I kept taking the medicine even complaining to doctors about my problems but it was always brushed off. I was and still am afraid to go to sleep because of the night terrors which I never had until I started using the medicine. I had such guilt and felt crazy from my sleep issues and understand I was told to take this medicine before I slept I never took it during the day I took it for years at night. It wasn’t until my husband finally got tired of being woke up and scared half to death from my screaming and panicking he said he didn’t want to hurt my feelings but I needed to seek serious help. I then became desperate the doctors were not helping me so I searched online and heard about the link between singulair and suicide and night terrors so I took myself off it and told the doctor why I was doing this and after a few weeks of being off my night terrors were not as bad but till now and it has been over a year I still have problems and I wonder now if I have permanent damage and will I ever sleep normal as I did before I started taking this medicine. It has made me a different person because I lack sleep because of my fear and I am very angry by this. I can prove I was given this medicine and would be more then happy to help. I can’t believe small children are having to experience this it is absolutely terrifying.
Our son was drastically affected with this horrible Singulair–We have documentation- How do we particpate i n the class action suit….
I was prescribed Singular over five years ago and have been treated for depression Just as long. My physician never told me about the side effects even though she knew how I struggled. Finally in desperation I started to research the drug and took myself off of the drug. I have lost all confidence all doctors and my primary in particular. Each psychiatrist I went to asked for a list of my medications and not one knew or didn\’t bother to find out the side effects. I have lost five years of my life, not to mention the hell I put my family through, to Singular.
Our daughter, 4 years old, was prescribed singulair for seasonal allergies. She became scared all the time, had night terrors, tantrums, vivid dreams, couldnt separate dreams from reality, had aggression… Two days after taking her off the prescription, most of the behavioral changes vanished, and we got our daughter back. She is still really scared and says ‘i don’t know how to stop being scared’. Parent discussion boards are full of these experiences. Please please sue the makers of singulair and make them stop pushing this terrible drug on kids.
My daughter was prescribed Singulair for asthma in 2008 when she was 11. It triggered a severe depressive episode involving suicidal thoughts, self injurious behavior, anxiety, personality changes, academic and social difficulties that resulted in her losing all her friends and ultimately changing schools. after eight months on Singulair we found a child psychiatrist who immediately took her off the Singulair. (Her asthma has been well controlled since that time with Flovent.) although she improved greatly once off Singulair she has continued to struggle with depression since that time, has been on Lexapro and then Zoloft daily and has twice-weekly talk therapy. I believe that her depression was triggered by Singulair, and I wonder if she will suffer from depression for the rest of her life. I hope that a class- action suit will be brought against Merck.