Pediatric adverse drug reactions collected by an electronic reporting system in a single tertiary university hospital

PURPOSE: The incidence of adverse drug reactions (ADRs) is increasing. However, studies on the prevalence of ADRs in children are rare. The aim of this study was to investigate the causative drugs and clinical features of ADRs for children in a tertiary university hospital of Korea. METHODS: We retrospectively collected ADRs by a computerized self-reporting system in Asan Medical Center. ADRs of children under the age 18 were collected from January 2005 to August 2015, and we analyzed only ADRs containing current symptoms among total ADR data. RESULTS: A total of 1,408 ADR cases were reported, There were 764 male (54.3%) and 644 female patients (45.7%), and the mean age was 11.5±5.8 years (range, 0–18 years). Antibiotics (n=479, 34.0%) were the most common causative drugs, followed by tramadol (n=173, 12.3%), nonsteroidal anti-inflammatory agents (NSAIDs) and acetylsalicylic acid (n=103, 7.3%), narcotics (n=91, 6.5%), antineoplastics (n=87, 6.2%), and sedatives (n=82, 5.8%). The most common clinical features were skin manifestations (n=500, 34.4%). Gastrointestinal symptoms (n=435, 29.9%) were the second most common clinical features, followed by neuropsychiatric symptoms (n=155, 10.7%) and respiratory symptoms (n=123, 8.5%). Among antibiotics, glycopeptides (n=110, 23.0%), third-generation cephalosporins (n=83, 17.3%), and penicillin/β-lactamase inhibitors (n=60, 12.7%) were the most frequently reported causative drugs. CONCLUSION: Antibiotics were the most reported common causative drugs of ADRs in children, followed by tramadol, NSAID, and narcortics. Compared with adults, the prevalence of contrast medium-induced ADR was lower in children with a higher prevalence of sedative-associated ADR. Greater attention to possible ADRs in children is needed among medical personnel.

Gastrointestinal Hemorrhage after Concurrent Chemoradiotherapy in Locally Advanced Pancreatic Cancer

BACKGROUND/AIMS: While chemoradiotherapy (CRT) is considered to be a reasonable treatment for locally advanced pancreatic cancer (LAPC), there is little information about the associated risk of gastrointestinal (GI) hemorrhage. We investigated the clinical features of GI toxicity after CRT in patients with LAPC and examined the effect of GI hemorrhage on survival. METHODS: Patients enrolled in this study had received CRT for pathologically proven LAPC. Their medical records were retrospectively reviewed. RESULTS: A total of 156 patients with LAPC (median age, 65 years; range, 39 to 90 years) who received treatment between August 2005 and March 2009 were included in this study. The most common GI toxicities were ulcer formation (25.6%) and hemorrhage (25.6%), and the most common grade 3 to grade 5 GI toxicity was hemorrhage (65%). The origins of GI hemorrhage were gastric ulcer (37.5%), duodenal ulcer (37.5%), and radiation gastritis (15.0%). The independent risk factor for GI hemorrhage was tumor location in the pancreatic body. The median overall survival of the patients with a GI hemorrhage was 13.8 months (range, 2.8 to 50.8 months) and was not significantly different from that of patients without GI hemorrhage. CONCLUSIONS: GI hemorrhage was common in patients with LAPC after CRT. Although GI hemorrhage was controlled with endoscopic hemostasis, preventive measures should be investigated to reduce needless suffering.