M Chalumeau1, G Chéron, R Assathiany, F Moulin, F Bavoux, G Bréart, G Pons. 1. Université 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
Abstract
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).
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).