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Reported Adverse Drug Reactions in Infants: A Nationwide Analysis in Malaysia
Rosliana Rosli1, Ahmad Fauzi Dali1, Noorizan Abd Aziz1
1Faculty of Pharmacy, Universiti Teknologi MARA Puncak Alam, Malaysia.
Insights
Spontaneous reporting of adverse drug reactions (ADRs) in infants under 2 years old in Malaysia revealed that antibacterials, particularly penicillins, were the most common cause of skin reactions. Most reactions were mild and occurred within 24 hours.
Area of Science:
- Pharmacovigilance and Drug Safety
- Pediatric Pharmacology
- Clinical Toxicology
Background:
- Spontaneous adverse drug reactions (ADRs) reporting is crucial for understanding drug safety in infants, as clinical trials primarily focus on adult populations.
- Evaluating ADRs in children under 2 years old is essential due to their unique physiological characteristics and developing systems.
- Malaysia's national pharmacovigilance database provides a valuable resource for analyzing pediatric ADR trends.
Purpose of the Study:
- To evaluate spontaneously reported ADRs in children under 2 years of age using WHO Adverse Reaction Terminology.
- To identify common drugs associated with ADRs in this vulnerable pediatric population.
- To characterize the nature and outcomes of ADRs in Malaysian infants.
Main Methods:
- Retrospective analysis of ADR data for children under 2 years old from Malaysia's QUEST2 System (2000-2013).
- Analysis included age, gender, reporting source, reporter type, suspected medicines, and ADR characteristics (category, onset, severity, outcomes).
- Data from 907 ADR reports (1312 ADRs) were analyzed.
Main Results:
- 14.0% of reported ADRs involved children under 2 years old.
- Skin appendage disorders were the most common ADRs (60.1%), with rash and maculopapular rash being frequent symptoms.
- Systemic antibacterials (58.8%), especially penicillins and other β-Lactam Antibacterials (>40%), were the most frequent drug culprits. Most ADRs were mild skin reactions occurring within 24 hours.
Conclusions:
- Systemic antibacterials are the primary cause of ADRs in Malaysian children under 2 years, predominantly manifesting as skin reactions.
- The study highlights rare cutaneous ADRs in this age group, emphasizing their significance as a cause of harm.
- Findings underscore the importance of pharmacovigilance for monitoring drug safety in pediatric populations.
Abstract:
Spontaneous adverse drug reactions (ADRs) reporting is a useful source of drug safety information in infants as only adult patients are routinely tested in clinical trials. This study was aimed to evaluate the spontaneously reported ADRs using WHO Adverse Reaction Terminology and to identify the common drugs associated with ADRs in children under 2 years of age. A retrospective analysis of ADR data for children below 2 years old from 2000 to 2013 was conducted using the data extracted from Malaysia's national pharmacovigilance database, QUEST2 System. From 2000 to 2013, Malaysia's National Pharmaceutical Control Bureau received a total of 11,932 reports for children from various healthcare facilities in Malaysia. 14.0% (n = 1667) of the ADRs reported for those children were related to children under 2 years old. The data retrieved was analyzed in terms of age, gender, source of reporting, type of reporters, suspected medicines and characteristics of ADRs (category, onset, severity, and outcomes). A total of 1312 ADRs reported in 907 ADR reports were analyzed. The most common ADRs reported were skin appendage disorders (60.1%), and the most frequently reported symptoms were rash (n = 215), maculopapular rash (n = 206), urticaria (n = 169), erythematous rash (n = 76), and pruritus (n = 58). In general, drugs from antibacterials for systemic use (58.8%) appeared to be the most common contributors to ADRs in children below 2 years old. Penicillins and other β-Lactam Antibacterials accounted for more than 40% of all drugs implicated in ADRs. The majority of ADRs were subacute reactions that occurred within 24 h of exposure to the drug. A high proportion of ADRs was classified as mild, and most victims had no sequela. Only one fatality was seen. There were 10 cases for each symptom, namely erythema multiforme and Stevens-Johnson Syndrome, observed in this study. A large proportion of ADRs in children under 2 years old were mainly caused by drugs from antibacterial for systemic use, with most of the ADRs manifesting in skin reactions. This study also reveals rare cutaneous ADRs experienced by Malaysian children under the age of 2, which constitutes a crucial cause of harm among children.
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