A Pharmacovigilance Study on Anti-Asthmatic Agent

Abstract

Pharmacovigilance plays a critical role in ensuring the safety and efficacy of anti-asthmatic agents, including inhaled corticosteroids (ICS), long-acting beta-agonists (LABAs), and leukotriene receptor antagonists (LTRAs). This study evaluates adverse drug reactions (ADRs) associated with these medications, emphasizing their clinical impact, risk factors, and patient outcomes. A systematic approach, including spontaneous ADR reporting, database reviews, and post-marketing surveillance, was utilized to identify patterns of drug-related complications, such as dysphonia, oral candidiasis, and cardiovascular risks. Findings highlight the importance of monitoring combination therapies, optimizing medication use, and enhancing patient education to improve asthma management while minimizing risks. Future directions include integrating pharmacogenomic data into safety assessments to personalize asthma treatment.

Introduction

overview of pharmacovigilance in asthma treatment, emphasizing the detection, assessment, and prevention of adverse drug reactions (ADRs). It highlights the importance of monitoring medications, particularly those used to treat asthma, as their therapeutic benefits can sometimes lead to significant side effects.

Key Points:

1. Pharmacovigilance in Asthma:

   • Asthma treatments, including bronchodilators, corticosteroids, leukotriene modifiers, and monoclonal antibodies, can cause ADRs.

   • Inhaled corticosteroids (ICS), though effective, may cause side effects like oral candidiasis, dysphonia, and osteoporosis.

   • Long-acting beta-agonists (LABAs), especially when used alone, can increase the risk of severe asthma exacerbations.

   • Newer biologic agents like monoclonal antibodies may induce immune-related side effects.

2. Asthma Pathophysiology:

   • Airway inflammation: Asthma involves an immune response that recruits inflammatory cells, leading to swelling and narrowing of the airways.

   • Bronchoconstriction: Smooth muscles constrict around the airways, limiting airflow, which is treated with bronchodilators.

   • Airway hyperresponsiveness and airway remodeling: Chronic inflammation can cause permanent structural changes in the airways.

3. Asthma Triggers & Etiology:

   • Asthma is genetically predisposed, but environmental factors like allergens, air pollution, respiratory infections, and obesity also contribute.

   • Genetic factors include certain genes related to immune system regulation, while environmental factors like allergens and pollutants can worsen the condition.

4. Diagnosis and Clinical Manifestations:

   • Asthma symptoms include wheezing, coughing, shortness of breath, and chest tightness, often triggered by external factors.

   • Diagnosis involves clinical evaluation, lung function tests like spirometry, and exclusion of other diseases.

5. Treatment:

   • Bronchodilators (e.g., beta-agonists) and anti-inflammatory drugs (e.g., corticosteroids, leukotriene modifiers) are used.

   • Inhaled corticosteroids (ICS) are the mainstay of long-term asthma control, reducing inflammation and preventing exacerbations.

   • Leukotriene receptor antagonists (LTRAs) block inflammatory mediators like leukotrienes, and mast cell stabilizers prevent allergic reactions by stabilizing mast cells.

6. Pharmacovigilance Studies:

   • Studies show that inhaled corticosteroids like Beclomethasone and Budesonide are linked to oral thrush, while beta-agonists like Salbutamol cause systemic ADRs such as palpitations and tremors.

   • Inhaler misuse can cause throat irritation, and polypharmacy increases the risk of drug interactions and ADRs.

   • Long-acting beta-agonists (LABAs) and anticholinergics may cause delayed or cardiovascular side effects.

Conclusion

This pharmacovigilance study on antiasthmatic agents highlight the significant role of monitoring and managing adverse drug reactions (ADRs) to improve patient outcomes. Inhalational corticosteroids, particularly Beclomethasone and Budesonide, are frequently associated with oral thrush, underscoring the importance of preventive measures such as oral hygiene. Beta-2 agonists like Salbutamol and long-acting beta-agonists (LABAs) such as Salmeterol can lead to systemic and cardiacADRs, necessitating dose optimization and ECG monitoring in at-risk populations. Leukotriene receptor antagonists, methylxanthines, and anticholinergics also exhibit distinctADR profiles, including headaches, tremors, and nausea, respectively, which emphasize the need for individualized therapy and vigilant monitoring.

References

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Copyright

Copyright © 2025 Sandip Mande , Sakshi Maknikar, Varsha Kshirsagar, Prajyot Manjramkar, Arati Landage. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.