The healthcare burden of asthma and allergic rhinitis is significantly higher than commonly recognised. Published reports anticipate approximately 40 million asthmatic patients residing in India. India has poor air quality, and the people are exposed to ambient PM2.5 (particulate matter with aerodynamic diameter ≤ 2.5 µm) far exceeding the limit set by the National Air Quality Standards in India. Cold winds during winter, along with farm fires and vehicle exhausts and road dust and other pollutants and allergens, further worsen asthmatic conditions affecting the large masses in India. Indian cities have been listed time and again among the most polluted cities across the world, highlighting the drastic air quality and its implication on respiratory health. Moreover, toxins from cooking stoves using biomass fuel and industrial fumes add another layer to the respiratory crisis in India even in smaller cities and villages.
Asthma and allergic rhinitis can be effectively managed with inhalers, nebulizers and oral medications. Inhaled corticosteroids (ICS) and oral leukotriene receptor antagonists (LTRA) are important therapeutic options. Among the various LTRA available, Montelukast is a widely available drug, potentially useful for improving allergic respiratory symptoms of millions in India. Montelukast works by blocking leukotrienes, chemicals responsible for inflammation and airway narrowing in the lungs. In conditions like asthma and allergic rhinitis, leukotrienes are released in response to allergens or pollutants, triggering symptoms such as wheezing, coughing, and nasal congestion. By inhibiting leukotriene activity, Montelukast reduces inflammation, alleviates symptoms, and improves breathing, helping some patients lead a more comfortable life.
Given the weather conditions and exposure to toxic pollutants, asthmatic patients require effective treatment options. Broad-spectrum therapies, such as Montelukast can sometimes provide significant symptom relief in a small subset of patients The drug provides the convenience of a once-daily oral dose, unlike inhalers and prolonged allergen immunotherapy treatments. This simplicity is particularly advantageous for individuals who face challenges with inhaler techniques or have limited access to specialized treatments. It also can control asthmatic symptoms over time rather than providing immediate relief which remains only for a short duration with as required or SOS inhaler use.
Montelukast targets the root pathways causing inflammation, reducing patient dependency on inhalers in a small subset of patients where it may be found to be quite effective. Clinical studies highlight the enhanced benefits of using Montelukast in combination with antihistamines for managing allergic rhinitis (AR). Research shows that pairing Montelukast with levocetirizine significantly improves symptoms and quality of life compared to using levocetirizine alone in some patients. Moreover, its affordability aligns with India's economic realities. At a per capita GDP of $2,172, many patients cannot afford more expensive options like multiple inhaler / nebulizer combinations or the newer injectible biological drugs recently being introduced for a subset of patients of severe asthma. Its affordability, accessibility, and convenient dosing make Montelukast an excellent treatment option for some Indian patients .
However, recently the US Food and Drug Administration (FDA) issued a black box warning regarding the usage of Montelukast in 2020. The FDA warning raised concerns regarding the rare neuropsychiatric side effects of Montelukast, such as mood and behavior changes, irritability, nightmares, anxiety, and suicidal ideation. This issue highlighted concerns regarding the potential neuropsychiatric adverse effects of Montelukast and stirred apprehension among healthcare practitioners and patients globally, including in India.
It is important to note that severe asthma itself is often linked to anxiety and depression, which can sometimes be misinterpreted as side effects of the medication. These factors should be carefully considered when evaluating patients and side effects.
In India, where environmental factors like severe air pollution and distinct healthcare scenarios critically influence respiratory health, Montelukast has established itself as a popular treatment option. Montelukast’s ease of use, affordability, and accessibility make it useful treatment option for many patients in India. While rare neuropsychiatric side effects have been reported, its ability to provide substantial relief and improve respiratory health remains far more prevalent and impactful. Ensuring its continued effectiveness requires a balanced understanding of its risks and benefits, coupled with diligent patient monitoring and responsible prescribing practices including careful patient selection where it is considered to be beneficial .
Indian healthcare providers should judicially prescribe Montelukast by identifying the right patient population rather than abandoning it completely. The GINA (Global Initiative for Asthma) guidelines clearly include Montelukast as a second or alternative controller option in the stepwise approach to asthma medication and therapy. Patients should be screened for their history of neuropsychiatric events and proactively monitored for unusual behaviors such as mood changes, anxiety, or suicidal thoughts.
Educating the patients and the caregivers about the benefits of the drug along with its potential risks is important to ensure its safe and effective usage. Open communication between doctors and patients can empower patients to identify unusual behavioral symptoms and report them promptly. This proactive reporting enables timely intervention, whether through dosage adjustments or alternative treatments, to reduce risks and provide the best care.
Montelukast has emerged as a vital medication, helping millions of Indians manage respiratory conditions and breathe easier as it helps control asthma and nasal blockage and allergic rhinitis. Responsible use is key to maximizing its benefits. This involves improving prescribing practices, avoiding unnecessary combination formulations and educating patients about Self medication use and overuse and tailoring treatment by personalized patient management as in selecting patients where other treatments like antihistamines have been ineffective. With a proactive approach, healthcare professionals can ensure Montelukast remains as an option in the Asthma and Rhinitis pharmacopeia for selected patients providing relief and enhancing the quality of life for countless individuals across the country.
