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What took the FDA so long to issue a montelukast warning about serious neuropsychiatric reactions? We are constantly amazed that the Food and Drug Administration moves so slowly when it comes to serious adverse drug reactions. The journal BMC Clinical Pharmacology (March 17, 2008) concluded:
“A possible signal for montelukast and psychiatric adverse drug reactions was found, which should be further explored.”
It took the FDA quite a long time to put some teeth in the montelukast warning. Earlier this month it issued its highest warning…a black box! This reader confirms that the montelukast warning is appropriate.
No Longer a Moody Teenager:
Q. My 14-year-old son had been on the asthma drug Singulair for several years when he was diagnosed with depression. The doctor suggested prescribing an antidepressant.
When I searched online, I found out that depression is a side effect of Singulair. Several individuals reported suicidal tendencies and severe mood swings in addition to depression.
My son has been off Singulair for about three weeks and is a happy boy again. He’s not even a moody teenager!
A. Reports of a link between montelukast (Singulair) and depression have been surfacing for more than a decade. In 2008, the FDA issued a preliminary montelukast warning that this drug for hay fever and asthma might cause agitation, sleeping problems or depression.
Now, the agency is emphasizing the connection with a black box montelukast warning in the prescribing information. According to the FDA, people should stop montelukast and see a health care professional if they develop:
Agitation
Attention problems
Depression
Confusion
Anxiety
Memory problems
Obsessive-compulsive symptoms
Trouble sleeping
Suicidal thoughts or behaviors
Here are some selected excerpts from the FDA News Release (March 4, 2020) announcing the montelukast warning:
“The boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis.”
“We recognize that millions of Americans suffer from asthma or allergies and rely on medication to treat these conditions. 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,” said Sally Seymour, M.D., director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.”
“As part of its review, the FDA re-evaluated the benefits and risks of montelukast as the treatment landscape has evolved since the drug was first approved in 1998. Based upon this assessment, the FDA determined the risks of montelukast may outweigh the benefits in some patients, particularly when the symptoms of the disease are mild and can be adequately treated with alternative therapies.”
This Reader Wants OTC Singulair!
Q. Why isn’t Singulair (montelukast) available over the counter? It has a better safety profile than antihistamines and is safe in children. How does one advocate for a generic drug to change its classification to OTC?
A. The FDA has approved montelukast to treat asthma, exercise-induced bronchoconstriction (trouble breathing) and allergic rhinitis. It is not approved for use during an acute asthma attack.
We wish that this oral medicine were as safe as you suggest. Drug companies are required to warn prescribers that it may trigger serious neuropsychiatric events, including aggression, agitation, depression, suicidal thoughts and even suicide. These reactions may not be common, but as a result, the FDA notes:
“the benefits of montelukast sodium may not outweigh the risks in some patients.”
Other side effects include severe allergic reactions to the drug itself and seizures.
It makes sense for such a medicine to be available, as the FDA recommends,:
“for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies.”
Readers have described undesirable reactions to this medicine. One mother wrote:
“My 10-year-old happy child was put on montelukast and became very sad and depressed. As soon as we took him off montelukast, his happy disposition returned.”
A wife reported:
“My husband took this drug for asthma and allergies and experienced severe, debilitating episodes of depression. It got so bad that he became suicidal. This drug should be taken off the market, as it is extremely dangerous.”
Such reactions make a medicine inappropriate for over-the-counter use. Many people might not take a montelukast warning seriously on an OTC package. Here is a link to an article about the importance of boxed cautions, especially with regard to montelukast warnings.
What has your experience been with Singulair? Has it worked well for symptom relief? Have you experienced any side effects? Please share your story in the comment section below.
Renee
My elderly father was prescribed montelukast. He began having scary hallucinations at night that I feared were a sign of dementia. His doctor agreed the hallucinations were likely a sign of dementia. When I read about Montelukast’s association with neuropsych symptoms, I emailed my dad’s doctor about discontinuing the drug. His doctor didn’t believe the hallucinations were drug-related, but agreed to have him stop taking Montelukast. My dad’s hallucinations ended when he stopped taking Montelukast.
Cindy
I’ve been on Singulair for 10 years and yes, I was agitated, depressed, very moody, and anxious. I could not sleep well. So I’ve been taking melatonin every night but am still not able to sleep well!!! Going to tell my doctor about this!!!!
B
Have been taking it for years due to severe allergies. I’ve had no issues with it.
Jean
When I was prescribed this I had terrible muscle aches in my legs. I started and stopped taking the medication over the course of a year to test it. It definitely was the Singular.
David
I have suffered from chronic rhinitis and allergies for 60 years. Surgeries, antihistamines and allergy injections helped some but didn’t address other causes such as inflammation from environmental factors. I started montelukast about a year ago and it has changed everything. My quality of life is much improved. Indeed, it has difficult side effects such as mild agitation and anxiety. But these have moderated over time, and because I understand them, I feel the trade off for sinus symptom relief is worth the discomfort. I have not had depression or suicidal ideations. I’m angry that none of my many specialists ever suggested it. I learned of it online and got it from my PCP. So frustrating.
Cherl
I was prescribed montelukast a year and a half ago for severe allergies. It has helped give me great relief from the allergy symptoms. I occasionally have trouble sleeping, but not all the time. I tried stopping this last spring and the allergy symptoms became intolerable again, so I resumed. For me, the occasional sleep trouble is worth the allergy relief. Thankfully, I haven’t noticed any mood changes.
Sherree
I have been taking Montelukast 10 mg for nearly 20 years with no adverse reactions. I’m grateful because it has allowed me to cut my steroid inhaler use in half.
Marylaine
Singulair increases eosinophils which can bring EGPA ( Churgg Straus disease) to a head. Anyone with raised eosinophils ( a normal white blood cell) should Not take Singulair.
Andrew
I am one of those patients who was given Montelukast for my mild asthma and Not told by my Pulmonary Doctor about the possible adverse psych effects, such as Depression, that it could have on you. Well, I was already suffering from Depression but it was well-managed by an anti-depressant drug I have been taking for a long time. And the Montelukast made my Depression worse, causing me to stay in bed & not want to face the day. At first I thought the dosage level of my anti-depressant was no longer effective, and was going to ask my prescriber to increase the dosage. But luckily I came across a medical article that reported the FDA had put the ‘black box’ warning on Montelukast, and stopped taking it. After a few days, I was back to my ‘normal’ self and could get out of bed to face the day again.
Katie
It is used for people with chronic spontaneous hives also. It’s a game changer for us. I have had no issues with this drug and have taken it nightly for years
Deborah
I had been on Singulair and Montelukast for years and was not having any asthma symptoms. I read the warnings on this site and decided to stop. Since I stopped I have had several episodes where I have had to use my inhaler. I am considering asking my doctor to once again prescribe Montelukast.
Petra
My 10 year old happy child was put on Singulair and became very sad and depressed. As soon as we took him off Singulair his happy disposition returned.
Matt
I began taking Singulair (Montelukast) over 20+ years ago for mild asthma. I got depressed and anxious. I saw a psychiatrist and went on antidepressants but I couldn’t sleep and went on an additional antidepressant Trazodone for sleep. Over the years I began taking Ambien to sleep and then benzodiazepines for anxiety.
At times I felt like I had the flu. The sleep deprivation and the constant weary fatigue cut my career short. Over the last 3 years I have slowly cut these drugs out of my life but my anxiety and insomnia have been so bad that I am surprised I did not harm myself. I quit taking Montelukast after I read this article and the third night after quitting I slept 8 hours. I am so much better, I’m a new person and everyone can tell. My inhaler is all I need for my asthma.
Mary
I was prescribed Singulair for asthma due to respiratory allergies. I took one pill one night and suffered horrible, hallucinatory visions when I closed my eyes to go to sleep. I was awake the whole night; I was afraid to try to sleep. It was a very frightening experience. When I told my allergist, he said he’d never heard of such a reaction. I never took the medication again. A year or two later, a local teenager who was put on Singulair suffered altered moods and eventually committed suicide; he had been a happy, normal teen until he took this medication.
George
I have taken Montelukast (10mg)for over 10 years. I take it at bedtime and have NOT experienced any of the effects mentioned. I am 85 yrs old. I will try weaning my self off to see if I will miss the drug!
Greg
Singulair is a pill…why do you show an inhaler???
Joy
I have taken Singulair for several years in the spring when cottonwood trees bloom. I have never experienced any problems with mood alterations,etc. For me, the benefits for my asthma far outweigh potential side effects. (I realize that individuals respond differently to medicines.)
Val
I was so pleased to get montelukast last fall, because my allergic asthma was terrible last spring. I had a great fall, virtually no URI allergies, and very little need for an inhaler.
I watched my moods, and they varied pretty much as normal. Asked my MD in Feb. if I should stay on montelukast after allergy season ends, and got an answer, “Maybe.” Based on this article, I may reduce my use of it.
Dee
I was given the generic Montelukast last year. Shortly after taking it I experienced really vivid dreams. Some nights I even thrashed around and knocked things off my nightstand. Also talked in my sleep. I mentioned it to my doctor a few months ago, and she said, “That’s not something I have heard about, probably not from the med”. I hope she has heard about it now! I feel a lot better since I stopped it on my own.
MarshaGail
My husband took this drug as prescribed for Asthma & allergies and experienced severe and debilitating episodes of depression. It go so bad that he became suicidal. This drug should be taken off the market, as it is extremely dangerous.
Suzanne
Is this warning for the inhaler or does it include the tablet of Singulair 10 mg for allergy symptoms ??
Belinda
Last fall my husband had a knee replacement and the surgeon prescribed Singulair for the off-label use of reducing scar tissue. After about 3 days my husband became agitated, confused and anxious. Fortunately, he recognized the issue right away. We read every word of the prescription literature and with his doctor’s permission stopped the Singulair.
Within 48 hours he was calm and merely had to deal with the recovery from surgery. This highly recommended doctor seemed totally unaware that there are some nasty side effects to this drug. You can be sure that when he gets the other knee done in a few months, he will NOT be taking Singulair!
Dick
I am a 78 year-old male. I have been taking montelukast for about 6 years to treat an allergy to my dog, a 17 year old Black Lab. I have not noticed any of the symptoms listed. Once my dog crosses the rainbow bridge I intend to quit taking the drug and just rely on saline nose spray which I currently use at night on occasion.
TCJudi
It was prescribed to me for possible mast cell activation syndrome (MCAS), including chronic cough. It gives me very bad headaches that lasted about 48 hours. I had several trials with the same results. I had to stop taking it.
Kathryn
I have been taking Montelucast for over a year. The warning about psychological side effects has been included in the handout since I first began using it. Luckily, I am not affected by them so far.
Darlene
I have taken generic singulair 10 mg (Camber mfg) for 4 years for asthma/allergies with no discernible side effects. Now age 78, but no way for me to know if it really works. Nothing changed when it was added.
Carolina
I have been on montelukast for years. It was prescribed by my regular doctor and later, by my allergy doctor. Neither doctor has mentioned anything about depression although they are aware that I take medication for it. I have had various ups and down with depression and now I am wondering if the montelukast has played a part. I have also wondered if I had been over-medicated at times because of depression, allergies, rheumatoid arthritis and breast cancer. I have tapered off montelukast and am beginning to notice a difference in my depression. My allergist is very concerned that I am not taking it anymore. I am concerned the allergist is more interested in prescribing drugs. I am proceeding cautiously.
Sherrie
I have been on Singulair or Montelukast for for several years. Is this also a warning for adults. I am 71 and as far as I can tell, I have no side effects from it. I do not have a tendency for depression though.
Richard
Well, this explains easily 30 years of on-again, off-again depression. Or, perhaps, more coincidental. I knew about “thrush-mouth” side-effects, but not once a suggestion of that black-box’s listings—all I’ve had. Sigh. If it’s not one damn thing it’s another with medicine.
Grandma
Had 3 grandchildren on this drug with serious side effects. Weight gain is also a serious side effect not listed. Issues seem to resolve when the drug is stopped.