Antibacterials frequently linked to adverse drug reactions in infants
Antibacterial drugs may account for two-thirds of adverse drug reactions (ADRs) in Malaysian children under 2 years of age, a new study suggests.
In a retrospective analysis of 11,932 reports of ADRs in children received by the Malaysian National Pharmaceutical Control Bureau (NPCB) from 2000 to 2013, researchers from Universiti Teknologi MARA (UITM) identified 1,667 reports (14.1% of total) related to children under 2 years. Of the ADRs analysed in this age group, antibacterial drugs for systemic use accounted for 61.9%. [Front Pharmacol 2017;doi:10.3389/fphar.2017.00030]
“The majority of ADRs were subacute reactions that occurred within 24 hours of exposure to the drug,” the authors noted. “A high proportion of ADRs was classified as mild, and most victims had no sequela.”
The most common ADRs reported were skin appendage disorders (60.1%), categorized as rash (n=215), maculopapular rash (n=206), urticaria (n=169), erythematous rash (n=76), and pruritus (n=58). The authors added that the common usage of antibiotics among this age group could account for its frequent association with ADRs, in addition to a general increased vulnerability due to their stage of physiological development.
Of the causal antibacterials identified, penicillin was the most commonly recurring (30.3% of all ADRs), followed by other β-lactam antibacterials (13.6%); macrolides, lincosamides and streptogramins (6.0%); and aminoglycosides (3.5%).
Exclusion criteria from the study included patients being older than 2 years; ADRs with causality evaluated as neither certain, possible nor probable; ADRs due to drug administration to the mother; non-citizen; non-drug products; reports with no information on ADR onset); and miscellaneous/others . After exclusion criteria, only 907 ADR reports (neonates, n=109; infants, n=798) remained for analysis, covering 1,667 ADRs.
Issues in ADR reporting
In discussing the results, the authors acknowledged that their data was limited to the NPCB’s spontaneous reporting database, and that ADRs among children under 2 years old could be underreported therein. A previous study by the same team found that the age group accounted for only 12.8% of reports to the NPCB between 2000 and 2013 for ADRs in patients aged 0 to 17 years. [PLoS One 2016;11(6):e0155385]
In addition to this, they highlighted that more than 90% of ADR reports they were able to obtain were submitted from healthcare professionals in the public sector, with the majority from pharmacists (51.4%), followed by doctors (38.7%).
“Active surveillance studies should be conducted in the Malaysian pediatric population since our findings as well as studies reported by Rashed et al. have shown relatively high rates of ADRs experienced by pediatric inpatients in Malaysia,” wrote the authors. “Future studies monitoring ADRs should be undertaken in a real hospital setting involving neonates and children under 2 years of age, as this study observed only a small number of ADRs for this group being reported to the national pharmacovigilance system.” [Eur J Clin Pharmacol 2012;68:801–810]