What effect does long-term use of montelukast sodium in children have on growth and development?

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In our comment area, the drug used for treating asthma and allergic rhinitis, is often mentioned,Parents always have some concerns when treating allergic diseases for their children –Is long-term continuous use of a certain drug not good for growth and development?
This issue, let’s talk about the impact of montelukast on growth and development.

What is Montelukast?

Montelukast is a selective leukotriene receptor antagonist,which we can understand by breaking it down:

📚“Leukotrienes”It is a potent lipid inflammatory mediator that, when combined with receptors, can mediate physiological responses such as “airway edema,” “smooth muscle contraction,” “increased mucus secretion,” “increased vascular permeability and pro-inflammatory” and so on,a series of airway inflammatory symptoms appear.

📚“Receptor Antagonist”

It inhibits the physiological effects of leukotrienes by binding to receptors(e.g., airway edema, bronchial constriction, and damage to normal cells), thereby reducing or even preventing inflammatory responses.

Leukotrienes have different subtypes, among which “cys-leukotrienes”(CysLT)are a class of potent bronchoconstrictor factors and innate immune effector cell activators,which have been proven to trigger asthma.Montelukast targets the “Type 1 CysLT” receptor,as a receptor antagonist, it is currently approved for the treatment of asthma and allergic rhinitis.(Asthma and rhinitis, we call “two babies from the same womb,” the two are closely related)

Indications and Precautions for Children Using Montelukast

Below are the indications for montelukast approved by the FDA:

1. Asthma: Suitable for children ≥ 12 months old.

2. Exercise-induced bronchoconstriction (EIB): Also known as “exercise-induced asthma,” suitable for children ≥ 6 years old.

3. Seasonal allergic rhinitis: Suitable for children ≥ 2 years old.

4. Perennial allergic rhinitis: Suitable for children ≥ 6 months old.

When used as a controller medication for asthma, montelukast can be used continuously
to prevent asthma symptoms from occurring.In a crossover study, for the early and late bronchoconstriction caused by allergen provocation in 12 asthma patients, montelukast
had an inhibitory effect. In the control experiment, montelukast reduced the inflammatory response of eosinophils in the airway and improved clinical symptoms, and it is because of this characteristic that it is used to treat asthma.

However, parents need to pay attention, during the medication process, it is necessary to monitorwhether the child has any neuropsychiatric symptoms, such as changes in behavior and emotions?That is the “black box warning” that has been much discussed. For details you can read this article: Montelukast with a ‘black box warning’, can children with cough and asthma take it?

It is estimated that many parents will say “Ever since I saw the black box warning a few years ago, I have been very cautious about using this drug.”. But indeed, some children need to use montelukast for a long time due to the condition, in this case, will it affect the growth and development of children?

What is the impact of long-term continuous use of montelukast on growth and development?

First, the answer:In terms of growth and development, montelukast has good tolerability and good safety.Because, in the patient population treated with “montelukast” or “placebo,” the incidence of adverse events observed is similar.

In a large randomized controlled trial, children with asthma taking montelukast for 56 weeks(Reference: about 52 weeks in a year)compared to the control group, no abnormal growth and development was shown.In a randomized, double-blind controlled experiment, the entire process of 4mg montelukast treatment for 12 weeks recorded physical examinations(including neurological examinations, height, weight, vital signs), common adverse reactions during the trial were asthma, urinary tract infections, and fever, and the probability of occurrence was similar to the control group,no serious adverse reactions related to the treatment were found.

In a randomized, double-blind, placebo-controlled, parallel group trial, children aged 6 months to 24 months, receiving 4mg montelukast for more than 6 weeks of treatment, compared to the control group, at baseline, there were no clinically significant differences in changes in vital signs, height and weight measurements or physical examination measurements,showing good tolerability.

Conclusion: Based on existing research and literature, compared with the disease itself, montelukast has a smaller impact on children’s growth.

When weighing the pros and cons, we should not only focus on the side effects of the drug itself, but also assess the harm brought by the disease itself.

The currently available evidence shows that asthma itself, especially severe, uncontrolled cases, may also have adverse effects on the growth and development of children.Controlling asthma well can not only avoid growth and development problems caused by the disease itself but also reduce the incidence and mortality rate.

The popular science comes to an end, and finally, I want to emphasize three points:

1. This article only discusses the concerns of “parents about the impact of drugs on growth and development.”

2.Parents are not advised to use montelukast for their children without supervision.If there are airway allergy issues, please use medication under the guidance of a doctor.If you have doubts about the doctor’s orders, you can consider seeking a second medical opinion and decide on the treatment plan after a comprehensive assessment.

3. It is recommended to regularly monitor the child’s growth during the treatment process, and if any abnormalities are found, communicate with the doctor in time to adjust the treatment plan.

Peer Review Expert Shujuan Luo

Distinct Children’s Respiratory SpecialistMaster of West China Medical Center, Sichuan University

References

1.Montelukast – StatPearls – NCBI Bookshelf2.Uptodate

3.Montelukast: its role in the treatment of childhood asthma

4.An Evidence-Based Review: Montelukast in the Treatment of Allergic Rhinitis

5.Treatment of Allergic Rhinitis in Infants and Children: Efficacy and Safety of Second-Generation Antihistamines and the Leukotriene Receptor Antagonist Montelukast

6.Safety, tolerability, and exploratory efficacy of montelukast in 6- to 24-month-old patients with asthma

7.The impact of asthma and its treatment on growth: an evidence-based review

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