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Singulair Lawsuit Filed Over Failure to Warn About Risk of Suicidal Thoughts, Other Neuropsychiatric Injuries

  • Written by: Irvin Jackson
  • 12 Comments

According to allegations raised in a recently filed lawsuit, side effects of Singulair caused a boy to suffer suicidal thoughts and a host of other psychiatric problems after using Merck’s asthma medication.

Stephanie Hammer filed the complaint (PDF) last month on behalf of herself and her minor son, identified only as R.S.B., in the U.S. District Court for the Eastern District of Wisconsin. The lawsuit came several months after the FDA required Merck to place a black box warning on the asthma treatment due to neuropsychiatric side effects.

Singulair (montelukast) belongs to a class of drugs known as selective leukotriene receptor antagonists. It is a pill taken orally once a day to treat asthma, exercise induced asthma and seasonal allergies. Singulair is recommended and prescribed regularly for both children and adults.

However, the FDA issued a drug safety communication in March, announcing that the strongest label warning possible will be required for Singulair, featuring information in a prominent “black box” that includes data from a new review of an observational study, as well as ongoing adverse event reports involving mental side effects, including suicidal behaviors.

According to the lawsuit, R.S.B., of Wisconsin, was prescribed Singulair to treat his asthma and hay fever symptoms in December 2010, and used the medication until August 2012. The lawsuit claims that, as a result of his Singulair use, R.S.B. was admitted to a psychiatric care facility due to suicidal and homicidal thoughts. He was subsequently diagnosed with major depressive disorder, anxiety disorder, obsessive-compulsive disorder, homicidal thoughts and other psychiatric disorders.

“Singulair causes a decrease in neuronal proliferation (nerve growth) in the hippocampal neurogenic zone (part of the brain largely involved in things from short-term memory to long-term memory, and spatial memory),” the lawsuit explains. “In short, giving Singulair to healthy children can delay their nerve growth in the part of the brain that is most important to short-term memory, long-term memory and special memory. Furthermore, alterations in the hippocamus have been linked to a variety of cognitive pathologies such as anxiety, depression, addiction and neurodegenerative diseases such as Parkinson’s.”

Hammer and her son’s lawsuit presents claims of design defect, failure to warn, negligence, and breach of warranty. They seek both compensatory and punitive damages.

The FDA first required warnings about behavioral and suicide side effects of Singulair in 2009. However, the March warning indicated the agency continued to receive data on the problems, both from an observational study using data from the Sentinel Distributed Database, as well as ongoing reports submitted to the FDA Adverse Event Reporting System (FAERS). The agency first presented its findings at an advisory committee meeting in September 2019.

The FDA identified 82 cases of “completed suicide” linked to Singulair use at that time. The agency indicated that 45 of those cases involved patients older than 17 years old, 19 cases involved patients 17 years old or younger, and 18 cases where no age was indicated.

According to the lawsuit, about 9.3 million patients received Singulair prescriptions in 2018, with 2.3 million of those given to children under the age of 17.

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12 comments

  1. Laura Reply

    I knew I wasn’t crazy when my daughter, who was in elementary school,, was all of a sudden experiencing crying and anger outbursts, didn’t want to go to school, and she would say she was sad. The school office would call me to pick her up because she couldn’t stop crying. This was totally out of character for my daughter. I talked to her doctor multiple times, but was told nobody had complained about the medication and I was treated as if I was just a crazy overreacting mother. The doctor even divorced my kids as patients because I kept complaining that something was wrong because I was sure it had to be the medication and they got tired of dealing with me. To this day I believe my daughter still suffers from the effects of Singulair. Don’t give this to your kids!

  2. Ashley Reply

    My daughter has been taking this medication since she was 4 she is the only one of my children who has add , attempted suicide at 7 , had anger outbursts, uninterested in doing anything . Constantly wanted to die ,we couldn’t leave her alone , I just assumed it was affects of her add or something bigger then me , then her pediatrician told me about the black box warning and I contacted her pulmologist and we took her off the singular in days I saw huge improvements , thank god her attempted suicide was not a success I can’t imagine if it would’ve been , but hours of counseling and emotional distress over an asthma med she’d been taking for so long. Like I said I’ve seen huge improvements but how much is permanent

  3. Megan Reply

    My 7 year old son took Singulair for years and has suffered several of these side effects. I was told this medication was safe to give a young child after expressing my concerns about medication and his age. I am now more concerned about the long term effects this could potentially have on him.

  4. Dawn Reply

    Do not give this medication to your child abd do not think you are crazy if your child begins to experience anxiety, not eating, and failure to thrive. Seeking the zervices of naturopathic physician and taking my child off thjs nasty drug saved his life. Refuse this medication.

  5. Shelby Reply

    I had a coworker tell me today about a news program she watched about Singular. As she was telling me this and in the hours after my mind was going over and over what our kids have experienced. All three of my children were born with asthma and allergies. All three of my children have taken Singular. Thinking back, my middle son went through terrible anxiety out of the blue about school. We would have to study every night 3 weeks before any test and he was a nervous wreck before the tests even though he knew the study guides inside and out and had all As. This lasted about two years and then abruptly stopped. Looking back he was on Singular at the time. When my youngest son who is 12 years old was eight he came to me crying his eyes out saying he’s had thoughts. He then explained he was thinking of killing himself and he had a hanging canvas chair in his room and he thought of wrapping the cord that hangs his chair around his neck. What 8 year old old out of the blue thinks that way? We immediately went to his pediatrician and several counselors. My husband and I were devastated and at a loss. Thinking back he was on Singular. He went on antidepressants for about a year and was then weaned off. During that time he also stopped the Singular as his asthma had improved with age. He is now a happy go lucky kid who will tell you he doesn’t know why those thoughts came into his head. My oldest daughter in the 9th grade developed deep depression and anxiety with suicidal thoughts and was cutting a couple of years after that. Against we were devastated and at a loss. She had taken Singular when she was younger and sicker but then went off. About the time she entered 9th grade and high school basketball she started having exercised induced asthma and was put back on Singular. That’s relative to the time she entered a deep depression. She’s in college now and hasn’t been on Singular in a few years. We spent several years with her at the doctor and mental health counselors. She’s much better but still has some manageable anxiety. Looking back, the common denominator was Singular. My kids come from a two parent loving home. We aren’t rich but we also aren’t hurting for anything. I just never understood it and the time until I started reading the chilling effects of Singular. I feel guilty as a parent but I thought I was helping them breathe better. Had I known this years ago we would’ve stayed far away from Singular!

  6. Kimberly Reply

    My son when he was first started on the medication nose bleeds outburst moody and now they are diagnosed him as ADHD and after seeing the report. I see now it was because he’s on the medication for a long time for almost 4 years now thanks for all the input and the information that y’all have given out can help us to protect our kids and not be used as guinea pigs.

  7. Jennifer Reply

    My son was given this at 2 years old and is now 15, he has taken everyday. We have had all of these terrible side effects. He was having major asthma symptoms and it did help. Which is why we continued this long. He tried getting off of it a couple of times and got sick. We are now off of it. I pray he body is able to heal from this. I wish I would have been more diligent about it before. I was so overwhelmed with dealing with the asthma issues and focused on that. I am deeply saddened to know I was giving him something that was causing all the issues we were dealing with.

  8. Barbara Reply

    My now 14 year old daughter was put on singular at 5 years old following a new asthma diagnosis. She was on it for 4 years. We discontinued use because of the development of many painful canker sore outbreaks, nightmares, memory/ learning issues, depression and anger management issues, that we tried to work through with therapy. The canker sores and nightmares stopped right away but her memory loss issues that make her education difficult and some depression issues are still a struggle. Are there tests we should ask for or any other proof we need to get her help? I saved the asthma and allergy doctors notes and perscription reciepts attached to some warnings but I didnt save any of the bottles. My son was also perscribed singulair toward the end of my daughters usage but when his symptoms of mouth sores, night terrors and depression started that’s when I realized this drug is bad. We got him switched to the 2x / day steroid inhaler QVAR and he is doing much better. Only needing his albuterol inhaler for emergencies maybe twice a month. I dont understand why singulair is still being perscribed. In my families experience even if you even have minimal side affects during use, years after stopping this drug the memory and depression are definitely there and I believe singulair IS the cause. It should be recalled immediately!

  9. Temeki Reply

    I’m wondering this medication cause seizures, my son just started having them , he be on this medication for 14 years?????????

  10. Maria Reply

    Hi my daughter was prescribed singular medication from her pediatrician when she was in grade school for ear infections and allergies. I remember I noticed her being sad all the time and aggressive towards myself and our dog. I called the doctor and told her how my daughter was acting .the doctor told me to grab my dog and her sister and go in a bedroom and lock the door until she calms down. Than the doctor said she wanted my daughter and I to see her at the office to talk about what happened. The doctor wanted me to do Out patient to see a psychiatrist at the four winds . I said no I’am not going to take my young daughter there. There has to be a reason why she is acting like this . So the doctor told us to go to a pediatric development therapist. We went and told me my daughter is defiant and told me to read this book about child being defiant. I told I don’t have time to read this book. There had to be a reason why she is acting like this. After a couple of months my daughter started to get up set with me if I went home a different way. She would start to screaming crying and kicking my seat until I turned around and went the way she wanted to go .
    Long story short she got worse and started to become jealous of her older sister because she took a lot of my attention because she is special needs. (Mild ID ). I kept on asking the pediatrician if it’s the medication they said no it was safe .when I would get the prescription filled I asked our pharmacist if this would cause aggression and anxiety. He would say no .until I asked him would he give this to his own child he said no . So we took her off this so called safe medication I think maybe 4or 5 years ago. She is still very aggressive with me and our dog, she’s been telling me she hates her life and don’t want to be here. Tells me she hates me and than starts to cry with anxiety kicking in saying I don’t know I’am so mean to you . This happened today ! I really believe that this medication singular took my happy little girl away ever since this medication at an early age has destroyed her life!!

  11. Cat Reply

    I’ve been on singular for almost over a year. I started having weird thoughts; crazy nightmares, and suddenly out of no where; massive fatigue. I couldn’t get out of bed for nearly 14 hours at a time. I had more serious night terrors and outbursts of anger! I have an esa pup and he’s the only thing that could calm me down but even being around him started to make me anxious! I stopped taking singular about 5 days ago. I have energy; less strange nightmares but now I’m having bouts of mania; that might have even cost me my job and the prescriber told me about NONE of these side effects, and even brushed it off when I said I was experiencing this; I got told it’s only early on

  12. Elaine Reply

    I’m 42 years old I was prescribed this poison about 2 years ago I was never warned about the side effects this drug has changed my life and not for the good I became severely depressed severe anxiety I didn’t want to live anymore I was never a depressed person before this medication I became very aggressive with my husband I became a very angry person again not who I am at all as a person then the physical side-effects I had loss of appetite just didn’t feel like eating anymore then the neausa hit me really bad it was so bad I couldn’t eat anything for 2 weeks at all ended up in the emergency room twice in the same week l lost weight from not being able to eat there’s so much more to my story but I’m still suffering from this poison a year later

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