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OBJECTIVE: The objective of this study is to determine the nature and severity of adverse drug reactions (ADRs) in pediatric patients. MATERIALS AND METHODS: In this retrospective cohort study, we extracted the data from all the available pediatric ADR forms submitted to ADR monitoring center (AMC) from May 2014 to December 2016. The data including nature, frequency, causality (World Health Organization [WHO] causality scale), and the severity (Hartwig and Siegel scale for severity) of ADR were extracted. We also assessed the preventability of the event on modified Schumock and Thornton scale of ADR preventability. RESULTS: There were a total of 20 pediatric ADRs reported during this period. Nearly two-thirds of the ADRs occurred in patients who were receiving multiple drugs (polytherapy). Antimicrobial agents were the most commonly implicated drugs. The most common ADRs were skin rash (maculopapular, erythematous, and urticaria, itching, etc.). The severity and preventability scales indicated that most reactions (18/20) were moderate in nature and all were preventable. Four reactions were "certainly" and ten ADRs were "probably" related to the suspected drug as determined by the WHO causality assessment. CONCLUSION: Frequency of ADR increased with number of medications patient was receiving. Health-care providers (HCPs) involved in the care of children must be aware of this fact and should use additional drugs when absolutely necessary. They should be involved in pharmacovigilance program by exchanging and updating each other through sharing constructive information, communication, and education concerning the appropriate use of drugs in children. Pediatric pharmacovigilance is the need of the hour and should be given utmost importance for monitoring the safety of drugs in children. Motivating HCPs for voluntary reporting of ADRs for preventing the morbidity and mortality in this vulnerable population could be of immense importance. [ABSTRACT FROM AUTHOR]

Gingival overgrowth (GO) is one of the common findings in clinical practice. There could be several causes including drugs associated with the GO. Carbamazepine (CBZ) and amlodipine are the drugs which are infrequently documented as a cause in inducing the gingival hyperplasia. Certain drugs in the body fluid might limit the population of plaque bacteria and alter their metabolism that in turn induce the inflammatory mediators and also activate the genetic and biochemical factors responsible for gingival fibroblast growth. Drug-induced GO is a side effect with a multifactorial etiology that seems to orchestrate the interaction between drugs and fibroblasts in the gingiva. We describe a case of trigeminal neuralgia with hypertension treated with multiple drugs including amlodipine and CBZ. Although amlodipine is known to be infrequently associated with GO, an association of CBZ with GO is even rarer. Causality analysis on the World Health Organization Uppsala Monitoring Centre's scale indicates a probable association with offending drugs. [ABSTRACT FROM AUTHOR]