Farmacoriflessioni
Sicurezza ed efficacia dei mucolitici in età pediatrica
SAFETY AND EFFICACY OF MUCOLYTICS IN PAEDIATRIC AGE
Loriana Tartaglia, Francesco Trotta e i componenti del Working Group Pediatrico dell’AIFA
Febbraio 2011 - pagg. 110 -113
Abstract
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.
Parole chiave
Suggerite dall'AI
Classificazione MeSH
Bibliografia
1. Nota Informativa Importante dell’Agenzia
Italiana del farmaco (AIFA). Mucolitici per
uso orale e rettale: controindicazione nei
bambini al di sotto dei 2 anni. www.agenziafarmaco.
it (accesso del 20.01.2011).
2. Domande e Risposte. Informazioni sulla
tosse nei bambini sotto i 2 anni d’età: perché
i mucolitici non devono più essere utilizzati?
www.agenziafarmaco.it (accesso del 20.01.
2011).
3. Gennazzani E, Giotti A, Mantegazza P.
Trattato di Farmacologia e Chemioterapia.
2° ed. USES, 1986.
4. Havez R, Degand P, Roussel P, et al. Biochemical
mechanism of action of cysteine derivates
on bronchial mucus. Poumon Coeur
1970;26:81-90.
5. Puchelle E, Girard F, Polu JM, et al. Effect
of the mucoregulator S-carboxy-methyl-cysteine
in patients with cyhronic bronchitis.
Eur J Clin Pharmacol 1978;14:177-84.
6. Goodman and Gilman. The pharmacological
basis of therapeutics. 11th ed. New York:
McGraw-Hill, 2006.
7. Chalumeau M, Cheron G, Assanthiany R,
et al. Mucolytic agents for acute respiratory
tract infections in infants: a Pharmacoepidemiologic
problem? Arch Pediatr 2002;9: 1128-
36.
8. Duijvestijn YC, Mourdi N, Smucny J, Pons
G, Chalumeau M. Acetylcysteine and carbocysteine
for acute upper and lower respiratory
tract infections in paediatric patients
without chronic broncho-pulmonary disease.
Cochrane Database Syst Rev 2009;(1):CD-
003124.
9. Mourdi N, Dubus JC, Bavoux F, et al. Les
fluidifiants bronchiques: vers une contre-indication
chez le nourrisson. Mucolytic drugs:
towards a contraindication in infants. Arch
Pediatr 2010;17:735-36.
10. http://www.afssaps.fr/(ultimo accesso
02.02.2011).
11. Smith SM, Schroeder K, Fahey T. Overthe-
counter medications for acute cough in
children and adults in ambulatory settings.
Cochrane Database Syst Rev 2008;(1):CD-
001831.
12. Rimsza ME, Newberry S. Unexpected infant
deaths associated with use of cough and
cold medications. Pediatrics 2008;122:e318-
22.
13. Marchetti F. La prescrizione dei mucolitici:
tra provvedimenti restrittivi e ricerca delle
evidenze. Medico e Bambino 2011;30:7-10.
14. Chang CC, Cheng AC, Chang AB. Overthe-
counter (OTC) medications to reduce
cough as an adjunct to antibiotics for acute
pneumonia in children and adults. Cochrane
Database Syst Rev 2007;(4):CD006088;doi:
10.1002/14651858.CD006088.pub2.
15. Crockett A, Cranston JM, Alpers JH, Latiner
KM. Mucolytics for bronchiectasis. Cochrane
Database Syst Rev 2001;(1):
CD001289; doi: 10.1002/14651858. CD00-
1289.
16. The Clinical Evidence. BMJ Publishing
Group. http://clinicalevidence.bmj.com/
ceweb/index.jsp.
Corrispondenza: l.tartaglia@aifa.gov.it