Singulair Suicide and Psychiatric Warnings Strengthened by FDA
The FDA has requested that the manufacturer of Singulair and other asthma drugs known as leukotriene inhibitors, such as Accolate and Zyflo, update their warning label about reports of suicide, suicidal thinking, aggression and other neuropsychiatric side effects.
The class of medications are commonly used to treat asthma and symptoms of allergic rhinitis, such as sneezing, stuffy nose, runny nose and itching of the nose. The body releases leukotrienes in response to allergens and other inflammatory stimuli, and inhibitors like Singulair (montelukast), Accolate (Zafirlukast) and Zyflo (zileuton) block the body’s release of these chemicals.
Singulair, manufactured by Merck & Co., Inc., is a top selling medication, with sales of $3.5 billion last year. Accolate and Zyflo, which are made by AstraZeneca and Cornerstone Therapeutics respectively, have much smaller shares of the market and are only approved by th FDA for treatment of asthma, not symptoms of allergic rhinitis.
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Learn MoreThe FDA requested that the manufacturers add a precaution in the drug prescribing information based on post-marketing reports of problems experienced by users of the drugs.
An on-going review of the potential side effects of Singulair and the other leukotriene inhibitors was initiated in March 2008 after reports of suicidal behavior, depression, hallucinations, insomnia, agitation, increased aggression, anxiousness and dream abnormalties were associated with the medications.
Although the FDA indicated in January 2009 that no evidence had been found to suggest a link between Singulair and suicide, the warning label update was requested to highlight that they are continuing to see the psychiatric problems among patients.
According to a statement posted on the FDA’s website June 12, 2009, the agency recommends that patients and healthcare providers should be aware of the potential risk of suicide and neuropsychiatric events with the drugs, and patients should be encouraged to contacted their doctor if they notice any potential side effects. Doctors have been advised to consider discontinuing the drugs if signs of suicide or other psychiatric symptoms develop.
Singulair already includes some label warnings regarding potential neuropsychiatric side effects, but the information will be moved to a more prominent location on the label in the “precautions” section.
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19 Comments
NcoleFebruary 4, 2020 at 8:36 pm
I have been taking singulair for about three weeks. Recently I have been agitated and EVERYONE is getting on my nerves, I'm sensitive and question everything people say. I cry out of nowhere for no reason and I'm just not happy in general. I dream all night long and don't rest well. I called my doctor and she said she had never heard of Singulair doing that and it sounded more like my hormones. [Show More]I have been taking singulair for about three weeks. Recently I have been agitated and EVERYONE is getting on my nerves, I'm sensitive and question everything people say. I cry out of nowhere for no reason and I'm just not happy in general. I dream all night long and don't rest well. I called my doctor and she said she had never heard of Singulair doing that and it sounded more like my hormones. She did tell me to stop taking them to see if that helped, but she acted like I was just crazy.
LindaOctober 17, 2017 at 8:37 am
My son who is now 23 years and disabled took singular many years , he stopped taking this drug due to the many side effects , he thought many times of committing suicide but luckily was never successful .
MistyAugust 23, 2017 at 7:15 pm
My dad committed suicide 18 days ago and was on Singulair for asthma. I cannot find an attorney firm in Washington state to take this case. It's not about money it's just high time to put a black box warning on this drug once and for all! The print and teeny tiny warning label on the bottle are so small I can barely read it and I have perfect vision. Who would think that a asthma /allergy drug wou[Show More]My dad committed suicide 18 days ago and was on Singulair for asthma. I cannot find an attorney firm in Washington state to take this case. It's not about money it's just high time to put a black box warning on this drug once and for all! The print and teeny tiny warning label on the bottle are so small I can barely read it and I have perfect vision. Who would think that a asthma /allergy drug would have depression or suicide as a possible side effect? Please FDA... do something so my dad's death is not in vain! How many more deaths need to happen?
LucyJune 1, 2017 at 12:42 am
It's a bad drug. There are many, many bad drugs. I'm in healthcare. More importantly, I'm a mom. When a doctor tells you that they have never heard of horrific side effects, they are usually telling the truth. They write prescriptions (some do) based on guidelines and limited, biased information. I know this from the inside. I mean the very, very inside. My son who has asthma was on Singulair. It [Show More]It's a bad drug. There are many, many bad drugs. I'm in healthcare. More importantly, I'm a mom. When a doctor tells you that they have never heard of horrific side effects, they are usually telling the truth. They write prescriptions (some do) based on guidelines and limited, biased information. I know this from the inside. I mean the very, very inside. My son who has asthma was on Singulair. It caused neuropsychiatric issues and I tried to research it using my usual channels (medical/pharmacological literature and research), the information was nebulous at best. I have spent months detoxing his brain and nervous system using Charlotte's Web cbd oil, and other things that I know will reduce inflammation and heal nervous tissues. What really gets me is how this drug is prescribed so carelessly, so ignorantly, to children, who are truly the most vulnerable population. A fellow provider tried to shame me about taking my son off Singulair at one point. I told her to do some research and get back to me with her judgments once she was fully informed. There other other meds and other ways to control asthma. Singulair needs to come off the market. That's not going to happen.It's one of many drugs that should never be prescribed. Most drugs do more harm than good. This is something people should know going into a medical office. If you have a bacterial infection, yes, I say get an antibiotic. If you are in need of emergency interventions, yes, take it all. But daily medications for chronic illnesses are insidiously dangerous. They will peck away at your health. Worse, if you are taking something to control an issues, and this is something you have to take long term, it's not a sure. It's a bandage, covering the real issue. Many kids with asthma have a multitude of allergies That's a good place to start. Asthma isn't a mystery, it's a symptom, a serious one, of a deeper issue. I hope the truth prevails. Parents, do your research. Your doctor is using google every day. You can use it too. Say no, ask questions, and find nutritional strategies for health. Drugs kill people more often than disease. I wake up every day and feel sick knowing that I am part of a system that is much sicker than anyone who seeks care. Pardon my rant. I hope all of you sue. I can't. But I will spread the truth quietly.
JanieSeptember 9, 2016 at 4:11 pm
My 17yr old son has been on Singular since 1999. When he was months old, had respiratory infection and was admitted to hospital. Since then, he has been prescribed Singular at bed time and Zyrtec during the day. It;s been 16 yrs on these meds. He has been more of an introvert over the years. I have had to be Homeschooling him in the past 2 yrs. Same story with my grandson which is now 18yrs of a[Show More]My 17yr old son has been on Singular since 1999. When he was months old, had respiratory infection and was admitted to hospital. Since then, he has been prescribed Singular at bed time and Zyrtec during the day. It;s been 16 yrs on these meds. He has been more of an introvert over the years. I have had to be Homeschooling him in the past 2 yrs. Same story with my grandson which is now 18yrs of age. After I saw this lawsuit on facebook. It now makes alot of sense as to their behavior. They have never been in trouble with the law. Pretty much have become homebound. Looking for help and have hope.
LindacNovember 30, 2015 at 4:03 am
Singulair helps my lung/breathing issues, but don't know how much longer I can endure side effects. Really brings on suicidal thoughts, nightmares, anger, and depression to name a few of the biggies. I pray to God for his intervention in each case. Going from 10 mg to 5 mg to see if that might be bearable.
TammywDecember 27, 2011 at 8:59 am
Does anyone knowif there is a class action suit against the makers of this product? My son has taken this since he was 3 and has had been told by his dr. he has night terrors, sleeplessness, sleep walking, out of control anger issues that have gotten him into trouble at school, and terrible mood swings of depression. We have medical bills that are extremely high and would love to have some help wi[Show More]Does anyone knowif there is a class action suit against the makers of this product? My son has taken this since he was 3 and has had been told by his dr. he has night terrors, sleeplessness, sleep walking, out of control anger issues that have gotten him into trouble at school, and terrible mood swings of depression. We have medical bills that are extremely high and would love to have some help with them.
Susan GNovember 25, 2011 at 9:39 pm
My child developed a serious case of ticks on singular... was terrible !! Took about 3 times of being off and on the meds to realize it was the mediciation..Took him to a Psychologist worried about as parents were we doing something wrong to cause him stress, than I thought it was school...was neither of these as he came off sigular his tic's begin to fade until they were gone within a few days.[Show More]My child developed a serious case of ticks on singular... was terrible !! Took about 3 times of being off and on the meds to realize it was the mediciation..Took him to a Psychologist worried about as parents were we doing something wrong to cause him stress, than I thought it was school...was neither of these as he came off sigular his tic's begin to fade until they were gone within a few days.... He is 13 so you can imagin the tics causing more stress for him... Singular is not for everyone... AND PARENTS SHOULD BE AWARE OF THE IMPACT ON THEIR CHILD tic's are not on there warnings,,,,,,,It also effected his behavior and grades
AmandaNovember 7, 2011 at 5:46 pm
I am on my way to the doctor to be taken off os singulair .Not being aware of the side effects I was on singulair the whole time that I was preganant and during that time when I schould have ben happiest I was extremely hostile to my friends and family and had thoughts of commiting suicide.I did not tell anyone beacause I was afariad that they would take my baby away when she was born and put me i[Show More]I am on my way to the doctor to be taken off os singulair .Not being aware of the side effects I was on singulair the whole time that I was preganant and during that time when I schould have ben happiest I was extremely hostile to my friends and family and had thoughts of commiting suicide.I did not tell anyone beacause I was afariad that they would take my baby away when she was born and put me in an institution.A year later after being off singular I read about the side affects and was schocked and a little relieved that I now knew where all of that anger and depresion was coming from.my asthma has worsened howver and the doctor renewed my prescription and i am on my way to tell him i can not and will not take that again.My baby has night terrors now I I can not help but to feel guilyt like it is my fault for taking singular while I was pregnant .I hope some day it will stop.
ErlindaNovember 1, 2011 at 9:42 am
I have been thinking this over and over again, what if the medical insurances will find time to ivestigate what caused the patients to be sick and admitted to the hospitals before paying the claiims. I'm sure, they could save a lot of money. The medical insurances should let the pharmaceuticals to pay the hospital and medical bills.of the victims. This way, the drug manufacturers and FDA will be m[Show More]I have been thinking this over and over again, what if the medical insurances will find time to ivestigate what caused the patients to be sick and admitted to the hospitals before paying the claiims. I'm sure, they could save a lot of money. The medical insurances should let the pharmaceuticals to pay the hospital and medical bills.of the victims. This way, the drug manufacturers and FDA will be meticulously careful before they bring out the Rxs to market.. Therefore, there will be less people to be handicap (like me) and less victims to suffer for their mistakes.
ErlindaOctober 31, 2011 at 9:12 am
I have severe asthma since 1991. My doctor prescribed Singulair to me. I took Singulair for almost one year. Until I felt weakness. I was at the mall with my husband and on our way to the parking area. I asked my husband to get the security guard to wheel me to our car, Since then I kept on falling until I finally decided to stay in our room. My family took turns in bringing me meals in our roo[Show More]I have severe asthma since 1991. My doctor prescribed Singulair to me. I took Singulair for almost one year. Until I felt weakness. I was at the mall with my husband and on our way to the parking area. I asked my husband to get the security guard to wheel me to our car, Since then I kept on falling until I finally decided to stay in our room. My family took turns in bringing me meals in our room. Until one a.m. my son came to our room and asked me a question but, I remained unconscious. He noticed some green stuff coming out from my mouth. Thank God, my sister called up and he told her what is happening to me. She asked him to call 911. The ambulance arrived immediately and took me to Tri-City Medical Center, Emergency, when they didn't get any responses from me. It took them time before they diagnosed me with "'vascultis". I stayed in the hospital for almost a month, from I.C.U. to regular room then transported to Rehabilitation Center where I stayed for another month. Most of the time the ambulance was in my house to pick me up. I was in and out of the hospital then. Now I can not walk w/o a walker or a cane. I have blood pressure maintenance, congestive heart failure, and thyroid Rx. It is sad to think that I took Singulair to heal me but, instead I got worst. I wish I didn't take Singulair anymore.
StephenOctober 1, 2011 at 3:58 pm
I was prescribed Singulair, not by my doctor but by a practice nurse during a routine asthma checkup. My asthma is usually very mild, but had been a bit worse than usual because of a chest infection. The nurse seemed desperate to push these pills onto me as they were going to 'revolutionise asthma treatment'. I am 32 and the only other health issue I have is arthritis. I didn't know anything about[Show More]I was prescribed Singulair, not by my doctor but by a practice nurse during a routine asthma checkup. My asthma is usually very mild, but had been a bit worse than usual because of a chest infection. The nurse seemed desperate to push these pills onto me as they were going to 'revolutionise asthma treatment'. I am 32 and the only other health issue I have is arthritis. I didn't know anything about the potential neuropsychiatric side effects of singulair. I really suffered for several weeks before realising the symptoms were being caused by the medication. I experienced feelings of panic, anxiety, depression and became increasingly suicidal. Life seemed pointless. I was so moody and irritable that I was even annoying myself. The worse I became, the less I wanted to see people. I actually didn't realise how bad things had got until the symptoms stopped. I actually thought I was losing my mind and that made me even more anxious and depressed. I shut myself off from my family and friends as much as possible. The only reason I realised it must have all been due to the medication was because I became too depressed to be bothered picking up my prescriptions. When I got better after running out of Singulair I realised what should have been obvious and then found out more online. So much is posted online quoting the FDA's January statement that it eclipses the later warning they issued in June. I don't doubt some people may benefit from this medication, but they really must be so careful to heed the updated FDA advice. It doesn't matter how rare the symptoms are, they are terrifying. If you know someone who is going to start taking this, please monitor their behavior.
Randy H.September 8, 2011 at 9:12 am
I stopped taking Singular a year ago when i had extreme suicidal depression. I more or less forgot about the severity of the side effects, and when i ran out of Claritin, noticed a bunch of left over singular. Within a week, bam--- extreme and unexplained thoughts of doom and suicide gripped me. Totally unnatural and overwhelming. I even missed a week of work just lying on the couch. T[Show More]I stopped taking Singular a year ago when i had extreme suicidal depression. I more or less forgot about the severity of the side effects, and when i ran out of Claritin, noticed a bunch of left over singular. Within a week, bam--- extreme and unexplained thoughts of doom and suicide gripped me. Totally unnatural and overwhelming. I even missed a week of work just lying on the couch. Then I remembered. This is the drug that makes you want to kill yourself. Stay away. And PLEASE keep your kids away from this stuff.
chaddiesmomJune 24, 2011 at 1:26 am
My son has been on singulair since he was about two. He began acting out, stabbing things with anything sharp, his anger got the best of him. I thought it was a typical two year old boy. Since he has been took off but he is nine now and some of it has not went away. Anyone else seem to be having similar problams.
shbpaigeJune 11, 2011 at 4:42 am
Wow. Thank you all for sharing. I thought my anger, dizziness, depression and occasional suicidal thoughts were coming from my PMS/hormones! I am sad, because singulair improved my life so much (as far as breathing goes). I guess it is time to try life with out it again, to see if it is causing all these side effects. I hope I can stick to this plan. I have sever asthma and it will be hard to[Show More]Wow. Thank you all for sharing. I thought my anger, dizziness, depression and occasional suicidal thoughts were coming from my PMS/hormones! I am sad, because singulair improved my life so much (as far as breathing goes). I guess it is time to try life with out it again, to see if it is causing all these side effects. I hope I can stick to this plan. I have sever asthma and it will be hard to adjust to being uncomfortable all the time again. I will post back soon and give an update. Thanks again for taking time to post your experienced.
GiusiMarch 17, 2011 at 8:52 pm
I took it for one week and it completely messed me up. I became angry, nervous, stressed out, tired, dizzy, suicidal, restless at night, forgetful. An awful experience. Took the rest of medications and tossed it.
JenniferOctober 6, 2010 at 12:51 pm
My son is 16 years old and has been taking this medication for almost 2 years now. He has always had middle child syndrome so it was not abnormal for him to have a few behavioral issues. He had always taken Claritin for his allergies but for some reason his Dr. switched his medication to Singulair. I was not able to link the connection until now finding out about these side effects. His behavior w[Show More]My son is 16 years old and has been taking this medication for almost 2 years now. He has always had middle child syndrome so it was not abnormal for him to have a few behavioral issues. He had always taken Claritin for his allergies but for some reason his Dr. switched his medication to Singulair. I was not able to link the connection until now finding out about these side effects. His behavior was completely out of control, his grades went down, he had bouts of rage that came out of nowhere and over the past several months would jokingly talk about things like killing himself, taking a knife and stabbing himself, overdosing, it was so unreal to hear that coming out of his month. I set up an appointment for him to see a psychiatrist immediately. This was not my son, he has such a wonderful heart and he was not himself at all. I just happend to read the label on the side of the Singulair bottle one day before I was going to get it refilled and saw the side effects and I was floored. I got online right away and started researching. He no longer takes this medicine and is back to his old self again. Do I think Singulair is the cause for his behavioral problems, not entirely but I know without a doubt it caused his minor issues to accelerate and without a doubt turned him into an out of control little boy without hope and with so much anger, it turned him into a monster. I am just so relieved I found out about this before it was too late. I highly reccomend anyone taking this medication experiencing any type of these symptoms please stop taking it immediately.
SHERRYJuly 14, 2010 at 7:44 pm
MY DAUGHTER WAS ON SINGULAIR FOR A WHILE AT WHICH TIME SHE HAD MANY OF THE RARE SIDE EFFECTS,MAYBE NOT SOOOOO RARE NOW.SHE CONSTANTLY COMPLAINED ABOUT SOMETHING HURTING, SHE TOLD ME SHE WANTED TO BLOW UP INTO A MILLION PIECES AND DIE, AT WHICH TIME I TOOK HER TO HER DOCTOR AND SHE WAS REFERRED TO PROCESS STRATEGIES TO DISCUSS HER FEELINGS. THIS ALL WENT ON FOR SEVERALYEARS UNTIL I FOUND A LARGE PR[Show More]MY DAUGHTER WAS ON SINGULAIR FOR A WHILE AT WHICH TIME SHE HAD MANY OF THE RARE SIDE EFFECTS,MAYBE NOT SOOOOO RARE NOW.SHE CONSTANTLY COMPLAINED ABOUT SOMETHING HURTING, SHE TOLD ME SHE WANTED TO BLOW UP INTO A MILLION PIECES AND DIE, AT WHICH TIME I TOOK HER TO HER DOCTOR AND SHE WAS REFERRED TO PROCESS STRATEGIES TO DISCUSS HER FEELINGS. THIS ALL WENT ON FOR SEVERALYEARS UNTIL I FOUND A LARGE PRINT AD OF THE SIDE EFFECTS AT WHICH TIME I PULLED HER OFF THE MEDICATION. HER DOCTOR WANTED TO KNOW WHO TOLD ME TO DO THAT....MY CHILD MY DECISION..THE DOCTOR SAID THEY HAD NEVER HEARD OF ANYONE HAVING TROUBLE ALL I COULD SAY WAS NOW YOU HAVE.SHE KEPT A SINUS INFECTION(2 0R MORE SOMETIMES IN THE SAME MONTH) AND SAID SHE SAW A LITTLE GIRL THAT WASN;T THERE,,TERRIBLE NIGHTMARES OF THINGS CHASING HER AND TRYING TO KILL HER. YOU CAN CLAIM THE MEDICINE HAS NOTHING TO DO WITH THIS...BUT AFTER TAKING HER OFF IT....IT WENT AWAY
JavierJune 15, 2009 at 2:49 pm
It doesn´t appear strange to me a drug coming from Astrazeneca, since they do Seroquel wich they new that produces same suicidal symtoms and worst Diabetes; now involved in Orlando trial ,cause diabetes and tardive diskinesia (unvoluntary tics), damage is permanent, by the 1000 lawsuits.