Characteristics of paediatric adverse drug reaction reports in Malaysia

During clinical trials, special populations such as children, pregnant women and elderly are excluded, creating lack of information on safety profile of medicines in these population. The lack of reliable efficacy and safety data often leads to under- or over-dosing in paediatric age groups which make them susceptible to adverse drug reactions (ADRs). This study was aimed to investigate the characteristics of ADR reports and serious ADRs among paediatric population in Malaysia. Descriptive analyses were undertaken for demographic characteristics and severity of the ADRs. Binary logistic regression was performed to identify association between selected variables and ADRs. A total of 3410 paediatric case reports for 6769 ADRs were reported within the 5-year period. Children aged one to 12 years old were the most frequently reported to experience ADRs (n=5488, 81%). Male gender exceeds more than half of the ADR reports (n=3812, 56.3%) and Malay race has the highest ADR reports (n=4780, 72%). Majority of the ADR reports were not serious (n=6285, 93%). Anti-infective medicines contributed most of the ADR reports (n=6024, 75%). The most common ADRs were from general disorders and administration site conditions (n=2879, 43%). A binary logistic regression showed male gender were more likely to experience nervous and respiratory system disorder ADRs (p < 0.05). Surveillance of medicines marketed for use in children must be strengthened to prevent severe life-threatening ADRs. Effective support decision tool for prescribing in paediatric population with an integrated pharmacovigilance monitoring will support continuous safety monitoring for all marketed medicines.