quote in full the AIFA important note regarding the contraindication to the use of mucolytics in children under 2 years of age
Dear Doctor, Dear Doctor,
Office di Farmacovigilanza dell’ Agenzia Italiana del Farmaco (AIFA) ha condotto una revisione di sicurezza dell’intera classe dei mucolitici per uso orale e rettale.
I principi attivi coinvolti sono stati: acetilcisteina, carbocisteina, ambroxolo, bromexina, sobrerolo, neltenexina, erdosteina e telmesteina , contenuti in numerosi medicinali che sono per la maggior parte dispensabili senza obbligo di ricetta.
Questi farmaci hanno attività mucolitica e fluidificante e sono per lo più prescritti, o somministrati dal genitore, nel trattamento delle affezioni acute e croniche dell’apparato respiratorio.
Un’analisi dei dati francesi di farmacovigilanza ha messo highlighted an increase in cases of respiratory obstruction and worsening of respiratory diseases in children under 2 years and receiving mucolytics. In fact, the drainage capacity of the bronchial mucus is limited in this age group, due to the physiological characteristics of the respiratory tract.
reported adverse reactions occurred primarily affecting the respiratory system (worsening of bronchiolitis, increased cough, increased bronchial secretions, wheezing, difficulty breathing, vomiting viscous), were for the most serious and required the ' hospitalization. The risk of these adverse reactions and the absence of efficacy data for pediatric in acute bronchial diseases, has led France to contraindicate the use of mucolytics in children under 2 years of age.
The AIFA, after reviewing the safety data available mucolytics the country, there are few data to support the effectiveness of these drugs in children under 2 years and on the basis of French data, adopted a restrictive measure, currently under implementation, to prohibit the use of mucolytics, oral and rectal use in children under 2 years.
This measure involves the introduction in the Summaries of Product Characteristics and Package Leaflet of the following changes:
- controindicazione all’uso nei bambini di età inferiore ai 2 anni;
- avvertenza sul rischio di ostruzione bronchiale nei bambini di età inferiore ai 2 anni;
- inserimento del termine “ostruzione bronchiale” nel paragrafo “Effetti indesiderati”, qualora la segnalazione di tale reazione avversa sia stata riportata.
Il paragrafo “Posologia e modo di somministrazione” sarà aggiornato di conseguenza, laddove necessario.
Si precisa che la controindicazione non riguarda l’uso antidotico dei medicinali contenenti acetilcisteina.
A seguito dell’introduzione della controindicazione, le confezioni a base di sobrerolo e ambroxolo, dedicated exclusively to children younger than 2 years shall be subject to revocation.
It is therefore considered necessary to draw the attention of general practitioners, pediatricians and pharmacists telling them that:
- mucolytics are prescribed or recommended always after careful evaluation of the benefit / risk of each patient and never in children under 2 years of age;
- to inform / educate parents on the proper management of cough, appropriate use of mucolytics and the availability of alternative therapies in children;
- pharmacists to make this possible risks and contraindications below 2 years of the parent who requires a mucolytic in order to prevent improper use of children in that age group. The AIFA
take this opportunity to remind all doctors and pharmacists of the importance of reporting suspected adverse drug reactions, as an indispensable tool to confirm a favorable risk benefit ratio in the real conditions of use. The
this Information is also posted on the AIFA, which is recommended for regular consultation with the best information and professional service to the citizen.
This Information paper prepared by the AIFA, covers all medicinal products for oral and rectal containing acetylcysteine, carbocysteine, Ambroxol, bromexina, sobrerol, neltenexina, and erdosteina telmesteina, regardless of their mode of delivery and was distributed by the National Association of Pharmaceutical Industry of self-medication (Anif), and by Assogenerici Farmindustria .
The Office of the Italian Drug Pharmacovigilance
