Singulair Suicide, Depression Risks Draw Strong “Black Box” Warning from FDA

Federal regulators are adding stronger warnings about the potential psychiatric side effects of Singulair, requiring a “black box” indication that the asthma and allergy drug has been linked to reports of depression, suicidal behavior and other mental health risks.

In a drug safety communication issued on March 4, the FDA announced 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.

Following the recent review, the FDA has upgraded previous warnings about the Singulair risks to indicate that use of the drug may cause suicidal thoughts or actions, and warning that for some patients the risks may outweigh the benefits, especially if their asthma symptoms are mild.

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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. The manufacturer indicates common side effects include stomach pain, diarrhea, fever, flu-like symptoms, stuffy nose, sinus pain or headache. Other side effects may include skin rashes, ear pain or swelling, severe tingling, and changes in mood or behavior.

“The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks,” Dr. Sally Seymour, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “With today’s action, the FDA aims to make sure patients and medical providers have the information available to make informed treatment decisions. Importantly, there are many other safe and effective medications to treat allergies with extensive history of use and safety, such that many products are available over the counter without a prescription.”

The FDA first required warnings about behavioral and suicide side effects of Singulair in 2009. However, this latest warning indicates the agency has 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 presented its findings at an advisory committee meeting in September 2019.

The FDA identified 82 cases of “completed suicide” linked to Singulair use. The agency indicates 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.

The FDA recommends that patients and parents or caregivers of child Singulair users stop using the drug and talk to a healthcare professional immediately if they see symptoms including:

  • Agitation and aggressive behavior
  • Attention problems
  • Bad or vivid dreams
  • Depression
  • Disorientation or confusion
  • Anxiety
  • Hallucinations
  • Irritability
  • Memory problems
  • Obsessive-compulsive symptoms
  • Restlessness
  • Sleepwalking
  • Stuttering
  • Suicidal thoughts or actions
  • Tremors
  • Sleeping problems
  • Uncontrolled muscle movements.

The FDA is asking health care professionals to consider the risks and benefits of Singulair before prescribing to new patients or continuing patients on the medication. The FDA warned doctors to inform patients of the potential mental health side effects and tell them to stop taking the drug if symptoms occur.

The agency also warned doctors to be aware that some neuropsychiatric events even after they’ve stopped taking the drug and urged them only to prescribe Singulair for allergic rhinitis patients if they have an inadequate response or intolerance to alternative therapies.

The FDA encourages health care professionals and patients to report any adverse events or side effects related to Singulair use to the FDA MedWatch Safety Information and Adverse Event Reporting Program.

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9 Comments

  • anneSeptember 24, 2020 at 1:02 am

    I was prescribed this drug in 2000 over at a allergy and immunology doc in St. Louis seems like he let his subordinates push him around that were underneath him should have retired. He gave me singulair I had problems I was coughing sounding like I was hacking up hairballs half the time and I am human. I was on that pill from 2000-2017 I found a doctor to take me off of the SIngular. If it does no[Show More]I was prescribed this drug in 2000 over at a allergy and immunology doc in St. Louis seems like he let his subordinates push him around that were underneath him should have retired. He gave me singulair I had problems I was coughing sounding like I was hacking up hairballs half the time and I am human. I was on that pill from 2000-2017 I found a doctor to take me off of the SIngular. If it does not make you sick it could eventually kill you. the doc in St Louis told me to exercise well if we would have taken me off of that crazy pill then I could have exercised but looking at him I would say he is an eggs bacon hashbrowns greasy spoon kind of guy and a double burger with curly fries that prescribed the singulair to me wore a pony tail a weird 1960s psychedelic dude I was afraid he was going to walk in one day and say far out. left over hippy with a beer gut prescribed that mess. I have now been off of it for a few years but I am dependent on Combivent respimat and albuterol inhaled steroids and a nebulizer with liquid Albuterol steroid I take Zirtec at night I take Xyzal in the day. I hope the people with this lawsuit going clean the bank accounts of this drug company out

  • AllySeptember 9, 2020 at 9:22 pm

    I used to take singulair when I was a young child up until I was about 9-10 (so a good 4-5 years). I’m 20 now and I’ve been struggling with severe depression and anxiety for years. Including self harm and suicide attempts. I still live with the side effects of this medication. I hope they’re drained of every last penny.

  • BelindaAugust 3, 2020 at 11:48 pm

    Gloria I feel you pain. I have the same side affects except the trimmers. I have been off this medication for almost a month not. I still have all my side affects. I would just like to know when or if they will ever end. I keep a folder at work for every part I run how to make my offsets ext. that way I don’t forget how to do my job. Someday are worse then others. I truly just want to be smart aga[Show More]Gloria I feel you pain. I have the same side affects except the trimmers. I have been off this medication for almost a month not. I still have all my side affects. I would just like to know when or if they will ever end. I keep a folder at work for every part I run how to make my offsets ext. that way I don’t forget how to do my job. Someday are worse then others. I truly just want to be smart again and stop feeling like I’m stupid and don’t know anything. In side my head I know what I want to say or do but it doesn’t come out that way anymore.

  • GloriaJuly 18, 2020 at 8:16 pm

    I had been on Singular for 10 years. The last 10 years of my life has been a nightmare. I started having terrible headaches, migraines, floaters in my eyes, tremor in my left hand, depression, anxiety, could not focus and was always emotional. I have been in and out of different Dr offices trying to get help. They did several brain MRI and everything would come back normal. I also had taken depres[Show More]I had been on Singular for 10 years. The last 10 years of my life has been a nightmare. I started having terrible headaches, migraines, floaters in my eyes, tremor in my left hand, depression, anxiety, could not focus and was always emotional. I have been in and out of different Dr offices trying to get help. They did several brain MRI and everything would come back normal. I also had taken depression and anxiety medicine off and on for 10 years. I had always been happy go lucky person. About a week ago, the lord put it on my heart and mind to check the side effects of Singular and I was shocked and saddened to see the terrible side effects. This drug needs to be taken off the market before it kills someone. It has been a week and the side effects are still bothering me, but getting better everyday!!! Thank god.

  • IsabellaJuly 6, 2020 at 6:56 am

    I took Singulair daily when I was 5, now 19, and it caused me to develop OCD. I washed my hands obsessively until the backs of my hands became so dry they cracked and bled. Shortly after being taken off of Singulair the OCD completely resided and I was fine.

  • JenJune 21, 2020 at 2:21 pm

    I have taken singulair daily for the last 15 years for what I was told was allergic asthma. About 13 years ago, I noticed difficulty focusing and remembering things. I found myself making lists for the simplest of days just to make sure I wouldn’t keep forgetting important things and deadlines. My ability to sleep became very impaired, causing even more difficulty being able to remain focused. I d[Show More]I have taken singulair daily for the last 15 years for what I was told was allergic asthma. About 13 years ago, I noticed difficulty focusing and remembering things. I found myself making lists for the simplest of days just to make sure I wouldn’t keep forgetting important things and deadlines. My ability to sleep became very impaired, causing even more difficulty being able to remain focused. I developed a hand tremor that caused me great concern as I am a physician. I have developed depression and am too embarrassed to seek treatment. That doesn’t mean that it has gone unnoticed by my husband who frequently asks me if I’m OK. I just discontinued Singulair today in hopes of some improvement in my tremor, memory problems, insomnia and depression.

  • TiffanyMay 10, 2020 at 1:22 am

    My daughter has been on Singulair forever now. She is now 19. Last year she was hospitalized for 2 weeks and we could not figure it out. Turns out Depression had a lot to do with it. She also started saying that she wished she would just die. And she is still struggles. We heard about this and I made her stop taking it right away.

  • TimApril 30, 2020 at 12:39 pm

    Our daughter now 9 has been on Singular (montelukast) for approx 5 years. Have have gone through horrible tantrums, lashing out fits. This continued to escalate to sadness, horrible anxiety , and loss of interest in all activities. Once we heard about this FDA warning we checked the box on everything they warned consumers about, immediately we took her off this medicine. We are going on approx[Show More]Our daughter now 9 has been on Singular (montelukast) for approx 5 years. Have have gone through horrible tantrums, lashing out fits. This continued to escalate to sadness, horrible anxiety , and loss of interest in all activities. Once we heard about this FDA warning we checked the box on everything they warned consumers about, immediately we took her off this medicine. We are going on approximately 6 weeks without taking the montelukast and it’s literally night and day difference. Our daughter is happy, going outside to play, enjoying life as we have always wanted her to. I strongly urge any one on this medication, especially children to get with your doctors and discuss other plans of action.

  • AlexandriaApril 20, 2020 at 7:02 pm

    I was 13 when I started taking the prescribed montelukast, soon after I fell into depression. I developed horrible anxiety and regularly thought about killing myself. I had to go to therapy until I moved. I stopped taking the drug as I didn’t feel like I needed it for my allergies anymore and I began recovering.

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