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Children on Montelukast - FDA requires Boxed Warning about serious mental health side effects

Daniel Moore • May 1, 2024

FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis

***Risks may include suicidal thoughts or actions

One of my main concerns as a physician is whether the benefit of a medication outweighs the side effects.

A young teenager that I've been treating has always had a measure of mood issues, distractibility and social anxiety. These symptoms are common in the adolescent population; you don’t have to be a doctor to know that! And so I attributed it to their personality. But recently they stopped a common drug prescribed to treat asthma, montelukast. And as a result of stopping the montelukast, they have had a profound improvement in their psychiatric symptoms. My patient is more focused, their thoughts are clearer and they feel more like themself. Their parents feel like the child they knew four years ago is back!

There are two things I take away from this experience. First, even though a side effect of a medication may be rare, it doesn't mean that it is insignificant in our patient population. Next, it is imperative on us to not give too much weight to anecdotal evidence. The Richmond area is infamous for exacerbating asthma symptoms. As a result, a number of our young people are started on montelukast and similar leukotriene receptor antagonists because we want to be able to provide relief from asthma symptoms. For many of these people, it's possible that the drug has prevented exacerbations, which may have landed them in the hospital or worse.

For those of us who do treat children with montelukast, we may want to consider trials off the medication to see if there are any changes in common psychiatric conditions, particularly if the child has been taking montelukast for some time. Childhood and adolescent mental illness is certainly not unusual, and there can be many, many causes but oftentimes we can fail to consider drugs that we consider relatively innocuous.

I hope in writing this blog is to draw attention to the new black box warning that has been placed on Montelukast and to discuss my experience with my own patient. The boxed warning isn’t new, it was issued by the FDA in March of 2020. But I was slightly focused on other health news at that time, and hadn’t really noted this warning. Patients can be more informed, particularly parents of children who are taking this medication, and physicians can be more aware of potential pitfalls that can come with prescribing this medicine.

One reason I like to have the type of practice I have is that we can talk about potential issues with medications and really address trials of going off of a medicine. For this particular patient, I've prescribed an alternative leukotriene receptor antagonist, but at this point parents are hesitant to start that. And I certainly can understand their hesitancy.

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