Pharmacovigilance in the paediatric respiratory medicine. The misuse of some mucolytic drugs in children

[Speaker] Ioan Magyar:1
[Co-author] Madalina Vidican:1, Cristian Sava:2, Andrea Badale:3
1:Pharmacology, University of Oradea, Romania, 2:Paediatrics, University of Oradea, Romania, 3:Pharmacology Institute, University of Debrecen, Hungary

Background. There are several agents with mucolytic properties. The main effect of these compounds is related to reduce viscosity of sputum. Seven years ago we observed a lot of children who presented in emergency department of paediatrics that the main symptoms were cough, wheezing, bronchospasm, and sometime reflex vomiting. The intensity and duration of cough and bronchospasm were strongly linked to orally use of carbocysteine. Method. Two years ago we noted the same symptoms after use of carbocysteine, acetylcysteine, and ambroxol hydrochloride in children. We tried to establish if a relationship between the use of these three mucolytic drugs and exaggereted cough or/and bronchospasm in children can be done. This time we focused on 220 paediatric subjects receiving one of the three mucolytic drugs: acetylcysteine, carbocysteine or ambroxol or even a combination of these agents. The statistical evaluation was carried out using chi square test. Results. The use for a few days of any of three agents was associated with prolonged coughing, the development of wheezing and even acute asthma episodes. By the age subgroup distribution we can emphasize that a significant percentage of children belongs to 1-2 years category (37.73%, 83 cases), folowed by the 3-4 years subgoup (24.09%, 53 cases). Other important aspect regard to use of mucolytic drugs in children is the presence and misuse of those three mentioned drugs in the management of respiratory infections or other respiratory diseases of infants: 38 cases in 0-1 years category. All three mucolytic agents are responsible for admission into the hospital in a great proportion: 43 of 48 admitted children. Conclusions. These drugs elicits an irritating effect on the airways. In children with asthma, recurrent wheezing or upper and lower respiratory tract infection the use of acetylcysteine, carbocysteine, and ambroxol should be avoided. Orally administered, these agents are relatively well tolerated, but clinical studies in chronic bronchitis and asthma have been disappointing. Overall, we believe that the use of carbocysteine, acetylcysteine, and ambroxol hydrochloride in children exceeds the therapeutic benefit.
Key words: mucolytic, children, pharmacovigilance

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