The bronchospasm and worsening of the cough as adverse drug reactions after carbocysteine in children

I Magyar1, A Maghiar2, B Cuparencu1, M Botea2, C Pantis3, R Dorcu1. 1University of Oradea, Pharmacology Department, 410068, Romania, 2University of Oradea, Emergency Department, Romania, 3University of Oradea, Anaesthesiology & Intensive Care Unit, Romania

Introduction. Carbocysteine is a mucolytic drug similar to acetylcysteine​​ regard to clinical uses. Carbocysteine is widely used in children with respiratory diseases such as bronchitis, pneumonia and other diseases in which the viscous and sticky tracheo-bronchial hypersecretion is present. Annually, in the paediatric emergency department (EDP) are evaluated, investigated and treated on average 24 000 children aged from a couple of weeks up to 18 years. Materials and methods. This study started from the observation that many children who received carbocysteine (and no other mucolytics and expectorants) on arrival in EDP presented a worsening cough (intensity and duration) and even phenomena of bronchospasm. We believe these indications are carbocysteine adverse drug reactions (ADRs). It is a retrospective study on 192 children who had various respiratory diseases, recorded at EDP – Oradea Clinical County Hospital, in the first four months of 2011. The special paper was used for the recorder of ADRs, a paper provided by Pharmacovigilance Department which belongs to Romanian National Drug Agency. Children were divided into two groups: group A (89 subjects) - who received carbocysteine and group B (103 subjects) - who have not received carbocysteine. The data were processed statistically using chi square test (χ2). Results. Discussion of the results. Girls predominated in group A (57.30%), while in group B boys predominated (53.40%) (p = 0.032). In group A more than 68.54% of patients were younger than 4 years, compared to group B where this percentage was 55.34% (p = 0.035). It can be observed a statistically significant difference between the two groups of patients. The most common symptom was cough in both groups (93.26% and 88.35%), followed by fever (65.17% and 65.05%) and rhinoreea (22.47% and 20.39 %). The most common combination of symptoms was cough + fever + rhinoreea (22.47% in group A and 20.39% in group B). In both groups prevailed the productive cough (46.99% and 45.05%). Dry cough and spastic cough was found in 21.69 percent and respective 12.05 percent in group A, respectively, 18.68 and 14.29 percent in group B. The two groups received especially antibiotics and antipyretic (49.44%, respectively 46.07% in the group A and 27.18% and 48.54% in group B). Combination of the two groups of drugs was recorded for 19.10% of patients in group A and 19.42% in group B. In the group that received carbocysteine the percentage of hospitalized subjects was 37.08%, significantly lower than in the non carbocysteine group (p = 0.006). Conclusions. In this study we sought to determine whether there is a direct correlation between the occurrence of cough, worsening of it, occurrence of bronchospasm or even respiratory failure. Our research does not show the presence of respiratory failure or some very serious symptoms that could have a direct connection with the use of carbocysteine. Instead it can be concluded that this drug has an irritating effect on the airways, thus, it should be used with caution in children. In all cases of worsening cough, this effect was credited ​​(anamnestic) on the use of carbocysteine. Also, the use for a few days of carbocysteine was associated with the development of wheezing and bronchospasm. In cases of asthma, recurrent wheezing or othe bronchospastic diseases the use of carbocysteine should be avoided. Generally, in the cases of children and especially in infants is advisable to provide mucolytics and expectorants as plants extract.

Key words: carbocysteine, cough, bronchospasm, children