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FDA issues Early Warning on Singulair and Suicides

Posted by Jane Akre
Friday, March 28, 2008 12:05 AM EST
Category: Major Medical, Protecting Your Family
Tags: FDA and Prescription Drugs, Vioxx, Singulair, Avandia, Dangerous Drugs, Wrongful Death

Singulair will be studied for a link to suicide after three or 4 reports.

  IMAGE:  Cat allergies are one that Singulair is taken to counteract

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IMAGE SOURCE: WikiMedia Commons/ cat allergy/Martin Bahmann

Singular is used by millions of Americans who suffer from allergies.  The FDA says it may be also used by some who are considering suicide.

The Food and Drug Administration (FDA) announced it is reviewing a number of reports after three or four patients experienced mood changes that led to suicides and suicidal behavior.

Drug maker Merck says Singulair is its best selling drug at $4.3 billion in sales last year. The drug has been used by millions since its 1998 release to treat allergies and asthma.

Merck stresses that none of the 11,000 patients enrolled in their drug trials has committed suicide and the FDA says this is just an effort to inform the public, no casual relationship has been established between the drug and suicide.

If you are taking Singulair under doctors’ orders you should not stop says a statement by the FDA.  But your doctor needs to monitor you for suicidal behavior or mood change.

The FDA is asking Merck to look into its data bank for any evidence of suicidal patients. The drug maker has updated its label several times over the last year to increase its warning of suicidal thinking and behavior, despite the fact that it has not determined any link to the drug's use.

The label now reads: "The following additional adverse reactions have been reported in post-marketing use: Psychiatric disorders: agitation including aggressive behavior, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), tremor."

But Merck stresses the label changes follow anecdotal reports from consumers, not data that the company has observed.

For asthma patients side effects include headache, flu abdominal pain and cough.

And many children are prescribed Singulair.

One doctor told ABC News "We have hundreds of children on Singulair and have never heard parents make complaints about psychiatric side effects," said Leslie Hendeles, professor of pharmacy and pediatrics at the University of Florida Colleges of Pharmacy and Medicine. "Moreover, there is no mechanism for this reaction … We will be telling our patients not to worry about this."

But an Albany, New York area couple is blaming their 15-year-old’s death last August on his switch to Singulair from Allegra.

In an effort to have an “Early Communication” with the public about any safety concerns, the FDA is acting more quickly to notify the public before they draw any conclusions.

That is in response to criticism that the FDA acted too slowly in informing the public about another Merck medication, Vioxx, which was taken off the market after it was linked to heart attacks, or GlaxoSmithKline’s troubled diabetes pill Avandia. #


27 Comments

Anonymous User
Posted by Cynthia Giordano
Friday, March 28, 2008 9:33 PM EST

My 6 yr old son was put on Singulair when he was 4 because he has severe allergies and asthma. I didn't make the connection at first, but within a couple of days of taking it, he began having nighttime hallucinations and then slumping back to bed. This was totally unlike his normal sleep behavior. I began to do some research online and read other parents stories - some that it was a great drug, but most took their kids off it because of bad side effects. I finally made the connection and took him off. There was an immediate change back to his normal behavior/sleep pattern and he has been off since, never to go back on. The doctors were a little unhappy that I took him off, but still supported my decision. After reading the article today I now realize that it was a good decision.

Anonymous User
Posted by Michelle Ramsey
Saturday, March 29, 2008 12:29 PM EST

My 7 year old has been on Singular for 2 years off and on and then has been taking it regularly since January and has major behavior problems in school now.He is ready to be suspended and is only in the 1rst grade.In February he had tried to strangle another classmate in the restroom and just last week he hit another boy in the back of the head in the restroom.Usually he is a very normal and quiet kid .I have been trying to figure out why his behavior and moods change so much.I am meeting with the Principal and school counselor this Thursday to discuss his behavior.I am going to call his Dr. and get his opinion on Monday.

Anonymous User
Posted by Katherine
Saturday, March 29, 2008 3:11 PM EST

My 17yr. old son has been on Singular for over 5 years. He just came to me last night and told me that
he has suicidal thoughts and has had these thoughts for the past 3 years. he did not come to me soon cause it would come and go. He also didn't understand what was happening. yes, the mood swings is there and also the insominia. I called his Dr. yesterday re:the new singular warning and the Dr. said keep him on!!!! I had no idea that he has been tormented by these thoughts...now what will happen? I am going to take him off the medicine but now we have to deal with the anxiety, depression and suicide.

Anonymous User
Posted by Lee
Saturday, March 29, 2008 3:13 PM EST

I didn't see the connection but my sone who is now 5 has been on sigular for 2 years. In the last 2 years he has been very aggitated, he wasn't like that before but he is so young I honestly thought that was his personality. Since I took him off the medication he is back to the way he was when he was a baby. He is happy and not moody at all. This has to be the cause there's no other explanation. I am now afraid of the long term effects this may have on him.

Anonymous User
Posted by Bethany
Sunday, March 30, 2008 9:31 AM EST

I have an 8 year old daughter who has been on singular for 3 months. she has made comments about killing herself and I don't know where she has heard that before. I don't know if it's now the medicine. I will be talking to ger doctor.

Anonymous User
Posted by Andy
Sunday, March 30, 2008 9:35 AM EST

Unpleasant mood changes - that is an understatement.

I am planning on leaving my wife this summer.

She has been taking Singulair for the last several years. Thank you Merck for turning my wife into a monster.

Anonymous User
Posted by michelle
Sunday, March 30, 2008 3:12 PM EST

My daughter, 2 1/2 years old has been on Singular for four months. I've noticed changes in her sleeping and some kind of unexplicable agresiveness.

Anonymous User
Posted by Matt
Sunday, March 30, 2008 4:55 PM EST

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


Merck has a serious problem with this drug and while not everyone is going to experience these same side effects, they are real and there is no doubt in my mind we will see this drug taken off the market after the FDA performs its investigation. BEWARE!!!!!!

Anonymous User
Posted by Mike
Monday, March 31, 2008 9:35 AM EST

My son is 14 yrs old and has been taking Singulair
for about3 yrs. and has taken off due to the latest news. Realizing that he has been having all the side effects but the suicide thoughts. And his schooling performance has dropped since the use of Singulair.

Anonymous User
Posted by Kevin
Monday, March 31, 2008 6:04 PM EST

Dare I say that this is only the latest of all-too-many lies and cover-ups by the FDA and the drug companies. Chantix, the popular drug used for smoking cessation, as another drug which falls under this category of psyciatric drugs being used in the general population. Chantix, of course, is a 'mood stabilizer,' but many people have committed suicide while on that drug also.

The fact that so many young children are taking this drug should frighten everyone, but considering the typical doctor's response as reported above ("We will be telling our patients not to worry about this"), well, that tells you all you need to know.

Thanks to Ms. Akre for her fine reporting on this issue.

Anonymous User
Posted by Cheryl Taylor
Monday, March 31, 2008 11:37 PM EST

My son started taking singular when the insurance company said the zyrtec was to expensive. So they got the doctor to give him a cheaper allergy medicine. He would then have asthma attacks because the allergy medicine didn't seem to be doing its job. So the doctor put him on singular and said he had to take it every day. My son was never a problem in school. He was nine when they started the singular. A few months after that I started getting notes from the school about him being agressive. Last year the notes came home more often. This year its like a once a week thing. The school councelor says its like boom all at once he does a 360 going from nice kind to very agressive and loud. A month ago he was complaining about his hands shaking. I figured he was playing to many video games. Looking back I see where his behavior changed shortly after he took the singular. He also went from a skinny child to an over weight one that can't seem to loose the weight. He also likes to just sit in his room by himself anymore. I thought maybe this was a growing up thing for boys. Two weeks ago he didn't want to take the singular anymore. Perhaps his body knew something I did not. In those two weeks he's stopped taking it he doesn't complain about his hands shaking anymore. If his mood swings stop soon I guess it wasn't a boy going through a stage thing but the medicine.

Anonymous User
Posted by ashley
Wednesday, April 02, 2008 11:39 AM EST

I began giving my 6 year old son Singulair for his seasonal allergies. He had three seizures while he was on it and the Neurologist felt sure that it was not the cause. However, after and MRI and other tests, there was not another reason for the seizures. Since I have taken him off the medication, there have been no further seizures or anger bouts!!!!!!!!!!!

Anonymous User
Posted by Lori
Wednesday, April 02, 2008 5:00 PM EST

My son has been on Singulair for 3 years. He is 6 and a half. As of Thanksgiving he is seeing therapist. My sunny happy child is almost sullen and although he is doing well in school he is having social issues. I pray Singulair is the cause but am waiting to hear from his dr. about the danger of taking him off. He has mild asthma.

Posted by Butler, PA
Friday, April 04, 2008 10:23 AM EST

This comment is for Andy who is planning on leaving his wife due to Singulair use. Andy, please don't leave. Have your wife quit taking the Singulair and see if she returns to her old self. I have been taking Singulair for 7 months and I too became a "monster". It was to the point where I thought my husband and I were going to break up. I quit taking Singulair 3 days ago and I already feel like my normal self. Your wife cannot help how the effects of this drug has made her feel. I hope you can be patient and try to work things out.

Anonymous User
Posted by Mathew
Friday, April 04, 2008 10:25 AM EST

I have a 11 year old sister who has been on singulair for years and no bad dreams, sucidial thoughts or anything, and suicide and mental illness runs in my family. Singulair does not cause all of these problems. There are just a bunch of hypochondriacs

Anonymous User
Posted by Rikki
Friday, April 04, 2008 12:10 PM EST

Does anyone know how long it takes to get out of your system? While I was researching sudden behavior changes, I came across this page - and it's funny - I was trying NOT to blame a recent visit with my son's father as the reason for his sudden behavior change. The school had problems with my son all last and this week. I'm kinda relieved to see that there may be a legitimate reason for his behavior issues. He doesn't take Singulair daily or for long periods of time - just when he has bronchitis or a cold to help him not cough thru the night - but he took it for about 4 days before the bad behavior began. Is that long enough for changes to start happening? He's been off for about a week and the behavior is calming but still not back to normal. Would love some input directly to me... Thanks...

Anonymous User
Posted by Rikki
Friday, April 04, 2008 12:11 PM EST

I can be reached at Rikkipg at yahoo

Anonymous User
Posted by Jenn
Friday, April 04, 2008 1:44 PM EST

my son hasnt been on this medication for about a year and a half, but had been on it steady for about 4 years... along with prelone when his asthma flared up bad... this year has been unbearable with him at school with anger and aggression, and random crying fits for no apparent reason. when i look back on his behavior over the years, he would do this ALOT when he was on the medication, but he hasnt been on it in quite some time. im not sure if this is related to the medication, but has anyone else had their child off of it for a while and then noticed behavior problems? email me: crazycamarogirl@hotmail.com

Anonymous User
Posted by Carolyn
Friday, April 04, 2008 1:55 PM EST

My grandson age 12 has been on singular for 3 years. Last year he started acting very moody, angry, depressed etc. His school work has went down hill and he has been saying that he hates his life and wants to die. I feel like he is someone that I don't know anymore. We are taking him off the singular and hope that he returns to his sweet and loving self. He has always been so happy go lucky,loving and caring. Now he says and does things that hurts our feelings and I really think even he doesn't know why.

Anonymous User
Posted by Preston
Sunday, April 06, 2008 7:22 PM EST

I am 17 years old, and i have been on Singular for over 3 years. I have been depressed for most of my teenage life, loosing freinds, dropped grades, and ive been suicidal for the past couple years, ive been off the medication for a couple of weeks, but its hard to switch the mindset, because i am still really depressed. The things i used to do for fun aren't fun anymore, and everywhere i go i have to fake a smile, i have almost attempted to commit suicide, and am happy to still be alive, though, i still feel like life is not worth living. I am still really violent, not only with myself, but with others around me aswell.
I am a victim to this horrible drug, which has almost taken my life. Fun is something I feel I don’t know anymore, I don’t know how to have it. How can i get this crap out of my system and start living my life again??

Please, help
prestoncooke@hotmail.com

Please save your loved ones and take them off this medication, I and many others are living proof

Anonymous User
Posted by Rhoda
Monday, April 07, 2008 12:46 PM EST

My daughter is two and 1/2 yrs. old. and began taking singular four days ago. She is kind and gentle. Yesterday when at a play area, she grabbed a little girl around the neck, and was told not to touch her again. She went back to play and threw the girl down and jumped on top of her. She could have hurt this girl, and she has never had this type of incident happen previously. My daughter has never been aggressive at all. This is a complete behavior change. It is like a 180 degree turn around, and is very concerning. She went back to normal behavior after the incident and could not articulate why she did what she did.

Anonymous User
Posted by Sasha
Wednesday, April 09, 2008 10:23 PM EST

I guess I'll like to echo the questions that other's have made about had anyone found occasional use (in my son's case, for croup, about 6 doses over the last year) to cause these behavioural changes, and does anyone yet know how long the effects take to wear off (if at all)?

Until about 10 minutes ago, I attributed my 4yr old's change in personality (cheery, outgoing, happy to sullen, cranky, and aggressive) last winter to some of the things that were going on in our lives at the time, but now I am wondering if it was something else.

If you can help, please email me at sasha at comnet dot ca

Thanks!

Anonymous User
Posted by Ang
Thursday, April 10, 2008 11:20 AM EST

My four year old son was put on Singulair about a month and a half ago for allergies/very light asthma. I was told that it would help him to possibly outgrow those conditions, and that we would re-evaluate in six months. At first I wasn't very consistent with giving it to him, but for the last two weeks or so he has had it every night before bed. For the last week he has not been himself. Whining a lot, upset about very little things, much more aggressive towards his sister, hitting, kicking, throwing fits. Twice this week his day care center staff pulled me aside and said he has been acting horribly. Upset about little things, angry, kicking, not listening, being very defiant...in short not acting like himself. Same as what we are seeing at home. It's like his behavior has regressed back to a two year old or worse.

I made an appointment for him today because of these behavior problems, plus he seems to be suffering a possible ear infection and bronchitis again anyway, which is what we started on the meds for in the first place. A co-worker remembered that we had recently started medication, and inquired about whether or not I thought that could be causing the behavioral issues. I did a search on google and came to this site and a few others. Reading these stories is like a light bulb switched on in my head! I feel horrible, why didn't I think to ask about side effects, why didn't I think about the meds being a possible cause of his behavior? No matter what the doctor says today, I am taking him off the Singular immediately. I will be in search of natural remedies to treat his allergies.

Anonymous User
Posted by Mindy Miller
Monday, April 14, 2008 4:39 AM EST

I am a pharmacy student and a mother of two sons that take Singular daily. My six year old has been taking it for 4 years, and my three year old for two years. They both have well controlled asthma. I wanted to reply to the questions many have posted about how long it takes to "get out of your system". The half life of Singular is 3-6 hours, so it is gone in a maximum of 18 hours. I came to this website while searching for information about recent FDA warnings. As far as I can tell, there are very few cases documented of mood changes and suicidal thoughts. There are many reasons why children have mood changes, and not feeling well because they have asthma and allergies could also be the source. I wonder if many who start Singular are also taking Prednisone, a steroid, to treat an asthma flare up. Steroids are definitely known to cause mood changes and is one of the reasons they can't be used long term. Please talk to your doctor or pharmacist before taking your children off of medication that may be helping them feel better in the long run.

Anonymous User
Posted by Gloria Dupre
Thursday, April 17, 2008 10:47 AM EST

I have been taking Singulair since i was in the 5th or 6th grade( now a Sophmore in college) but it has always been the 5mg chewable child's dosage, and never really had any sign of depression! I was a happy child engaged in school and extra curricular activities that loved going to school and learning! That is until my doctor bumped up my dosage this past year to the 10mg hard swollable pill! I started having anxiety attachs for no reason in the middle of the day! i would cry uncontrolablly for hours! I would over stress about school and work and friends and family and the littlest things would set me off! And even just recently i've been so depressed about school and relationships and work that i have thought of ending it all just to escape the pain and overload! please don't take this caution lightly! Since i heard about these now studies i have stopped taking singulair and have been gradually been seing inprovements in my self confidence and behavior! This is real and yes not everyone may experience thses side afects but that doesn't mean that they are not there!

Anonymous User
Posted by Katie
Friday, April 18, 2008 10:17 PM EST

My 2 year old son was put on singulair 4 weeks ago to treat his asthma. Last weekend we wound up in the ER after seizure activity -- eyes rolling back in his head, constant blinking activity, etc. The ER doc said they were febrile seizures because he had a temp at the time, but I didn't agree -- I had given him motrin 2 hours before the 2nd seizure and his temp was only 100.4. His pediatrician thinks they are petit mal (absence) seizures. My son is scheduled for an EEG next week and has an appt with a pediatric neurologist the following week. I suspected singulair almost immediately, though, and stopped the medicine right after our trip to the hospital. I haven't seen a seizure in 4 days...

Anonymous User
Posted by maurice
Monday, April 21, 2008 12:32 PM EST

Since taking the medicine singular, my son has suffered from anxiety, depression, tremors and other discovered side effects.  According to his eye doctor, his vision has dramatically worsten. According to his teachers, my child, who is an A and B honor roll student, his behavoir and ability to consentrate in school has change for the worst as well.  My wife and I have notice some major changes too.  Doctors have discovered something that they say is considered to be very rare for a child my son's age (11). So rare that, his condition was considered an emergency and he was admitted into the hospitatl immediately. Test have been ran and the doctors say that they are afraid to let him go home. The diagnois that the doctors come up with has symptoms that includes many of the same side effects as discribed by taking the medicine "singular". I believe that there is a connection between the medicine singular(cause) and my son's rare condition (effect).

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