Safety and tolerability of Esberitox® tablets in children with viral cold diseases: a post-authorisation safety study (PASS)

Aim: Documentation on safety and tolerability of Esberitox® tablets (Thujae occidentalis herba, Echinaceae radix, Baptisiae tinctoriae radix; formerly Esberitox® N) in a group of children from 4–11 years of age treated for viral cold diseases.

Methods: Two age groups were included in a prospective, open, multi-centre, non-interventional study: children from 4–6 years (dosage: 3×1–2 tablets/d) and children from 7–11 years (dosage: 3×2 tablets/d). The maximum observation period per patient was 2 weeks. At the initial examination the duration of the symptoms, the anamnestic frequency of cold diseases, an allergic disposition, the severity of the current disease, concomitant diseases, concomitant therapies and pretreatment of the current symptoms were documented. Dose changes, clinical complications (fever >38.5°C, bacterial superinfection etc.) and reasons for termination of the treatment were recorded at the follow-up visit. The tolerability of Esberitox® tablets and adverse events were explicitly questioned and documented in detail.

Results: The analysis comprises data of 266 children, of whom 138 were between 4 and 6 years and 128 between 7 and 11 years. Clinical complications (mainly fever or superinfections) were registered in 25 cases. The tolerability of Esberitox® was assessed as „very good“ or „good“ by 96–97% of parents and physicians. In six cases, treatment was terminated due to adverse events. Only two of them (with at least possible causality) were judged to be related to Esberitox® by the investigators: One case of itching and 1 case of abdominal pain with mushy stool. Both cases were mild in severity, reversible and non-serious.

Conclusion: Based on these results, the administration of Esberitox® tablets to children from 4 to 11 years of age can be considered as safe.