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Key words: Mucolytics, Adverse reaction, Risk/benefit profile, Italian Drug Agency
Following a signal from France, which showed an increase in the cases of bronchial obstruction and worsening respiratory disorders in children under 2 years of age treated with mucolytics, the Italian Drug Agency (AIFA) has revised the risk/benefit profile of this drug class (ATC R05CB), administrated by oral and rectal route, in children under 2 years of age, authorized at a national level. This re-valuation gave unfavourable results; indeed, despite the widely use of these drugs, mainly available without prescription, and in the absence of sufficient evidence of efficacy in children, the safety profile is compromised by the risk of serious adverse reactions. Therefore, AIFA has adopted a regulatory action, currently under implementation, to contraindicate the medicines, for oral and rectal use, containing acetylcysteine, carbocysteine, ambroxol, bromexine, sobrerol, neltenexine, erdosteine and telmesteine in the age class 0-2 years.
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