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[Mucolytic agents for acute respiratory tract infections in infants: a pharmacoepidemiologic problem?]
M Chalumeau1, G Chéron, R Assathiany
1Université René-Descartes, groupe hospitalier Cochin-Saint-Vincent-de-Paul, Assistance publique-Hôpitaux de Paris, Inserm U149, Recherches épidémiologiques sur la santé périnatale et la santé des femmes, Paris, France. martin.chalumeau@wanadoo.fr
Insights
The efficacy of mucolytics agents like acetylcysteine and carbocysteine in infants has not been proven. Evidence suggests potential safety concerns, including paradoxical bronchial congestion, particularly in younger infants.
Area of Science:
- Pediatric Pharmacology
- Respiratory Medicine
- Evidence-Based Medicine
Context:
- Mucolytics agents, including acetylcysteine and carbocysteine, are frequently prescribed for respiratory conditions in infants.
- Current prescribing practices and available scientific literature lack robust support for their use in this population.
Purpose:
- To evaluate the efficacy and safety of mucolytics agents in infants.
- To analyze prescription patterns and review existing literature on mucolytics use in pediatric patients.
Summary:
- A survey of 1327 infant prescriptions showed 4.3% involved mucolytics for rhinopharyngitis, cough, and bronchitis.
- No high-quality studies confirmed the efficacy or safety of these agents in infants for labeled or off-label indications.
- Six cases of paradoxical bronchial congestion in infants under eight months were reported, with potential overdosing concerns due to variable dosing recommendations.
Impact:
- Highlights the lack of evidence supporting mucolytics use in infants, challenging current clinical practices.
- Suggests a need for further research into the safety and efficacy of these agents in pediatric populations.
- Informs healthcare providers about potential risks and the importance of evidence-based prescribing for infant respiratory conditions.
Objective:
To study the use of mucolytics agents, i.e. acetylcystein and carbocystein, in infants. To evaluate their efficacy and safety for their main indications.
Methods:
A prospective one-day survey of prescriptions among 95 office-based pediatricians. A systematic review of the literature.
Results:
Among 1327 prescriptions regarding infants, 4.3% were mucolytics agents. Main indications were rhinopharyngitis, isolated cough, and acute bronchitis. Our review did not identify any study of rigorous methodological quality that supported the efficacy or safety of mucolytics agents in infants for their in-label (isolated cough, acute bronchitis) and off-label (rhinopharyngitis) indications. Six cases of infants, aged less than eight months, presenting paradoxical bronchial congestion during a treatment with mucolytics agents, have been reported to the French pharmacovigilance system. No causal relationship was established from these cases because of a possible protopathic bias.
Discussion:
Our results concerning mucolytics agents use are similar to those reported by the French Health Care Funds. In addition to the lack of studies on efficacy, no studies on the dose-response relationship were available, leading to suggested dose regimens in the French license of acetylcystein ranging from 44.4 to 16.4 mg kg-1 j-1 between one to 24 months. These dose regimens could predispose to overdosing in the youngest infants as it seems observed in the six reported cases.
Conclusion:
In infants, mucolytics agents efficacy has never been demonstrated and some elements suggest poor safety (paradoxical bronchial congestion).