scholarly journals Drug-induced hyperglycemia in the Japanese Adverse Drug Event Report database: association of evelolimus use with diabetes

2019 ◽  
Vol 66 (6) ◽  
pp. 571-574 ◽  
Author(s):  
Hiromi Konishi ◽  
Jun Shirakawa ◽  
Masanori Arai ◽  
Yasuo Terauchi
Keyword(s):  
Adverse Drug Event ◽  
Drug Event ◽  
Event Report ◽  
Drug Induced

scholarly journals Comprehensive Analysis of Antibiotic-induced Agranulocytosis Using the Japanese Adverse Drug Event Report Database

2021 ◽  
Author(s):  
Yuki Asai ◽  
Takanori Yamamoto ◽  
Yasuharu Abe
Keyword(s):  
Confidence Intervals ◽  
Adverse Drug Event ◽  
Shape Parameter ◽  
Comprehensive Analysis ◽  
Drug Event ◽  
Event Report ◽  
Odds Ratios ◽  
Drug Induced ◽  
Failure Type

Although infrequent, drug-induced agranulocytosis can be stimulated by antibiotics. Here, we analyzed the Japanese Adverse Drug Event Report database to identify profiles of antibiotic-induced agranulocytosis. Ten of 60 antibiotics showed signals for agranulocytosis; the reporting odds ratios (95% confidence intervals) for ampicillin/sulbactam, amikacin, cefmetazole, cefozopran, clindamycin, ciprofloxacin, imipenem/cilastatin, kanamycin, teicoplanin, and vancomycin were 2.65 (1.79–3.80), 2.49 (1.91–4.34), 4.48 (2.27–6.92), 2.77 (1.88–3.95), 1.64 (1.04–2.47), 2.01 (1.40–2.82), 2.78 (2.11–3.60), 6.05 (2.16–13.7), 2.05 (1.31–3.07), and 3.54 (2.73–4.54), respectively. The median times-to-onset of agranulocytosis for ampicillin/sulbactam, cefmetazole, cefozopran, clindamycin, imipenem/cilastatin, kanamycin, teicoplanin, and vancomycin were 20, 6, 10, 16, 12, 3, 18, and 13 days, respectively. The 95% confidence intervals of the Weibull shape parameter β for these antibiotics were over and excluded 1, indicating that the antibiotics were the wear out failure type. These findings provided insights into the characteristics of antibiotic-induced agranulocytosis.

scholarly journals Analysis of Drug-Induced Gastrointestinal Obstruction and Perforation Using the Japanese Adverse Drug Event Report Database

2021 ◽  
Vol 12 ◽  
Author(s):  
Riko Satake ◽  
Kiyoka Matsumoto ◽  
Mizuki Tanaka ◽  
Ririka Mukai ◽  
Kazuyo Shimada ◽  
...  
Keyword(s):  
Prescription Drugs ◽  
Adverse Drug Event ◽  
Barium Sulfate ◽  
Gastrointestinal Perforation ◽  
Drug Event ◽  
Event Report ◽  
Drug Induced ◽  
X Ray ◽  
Gastrointestinal Obstruction ◽  
Time To Onset

Drug-induced gastrointestinal obstruction (DIGO) and gastrointestinal perforation (DIGP) may be the result of gastrointestinal hypomotility and severe constipation, which may lead to potentially fatal complications of bowel ischemia, sepsis and perforation. We evaluated the onset profile of DIGs (DIGO and DIGP) associated with prescription drugs by analyzing data in the Japanese Adverse Drug Event Report (JADER) database. We selected 161 DIG-related drugs and categorized them into 19 classes based on the Anatomical Therapeutic Chemical (ATC) Classification System. Finally, we focused on 58 drugs and conducted subsequent analyses for the time-to-onset and outcomes. We extracted 79 preferred terms (PTs) with the strings “ileus,” “stenosis,” “obstruction,” “obstructive,” “impaction,” “perforation,” “perforated,” “hypomotility,” and “intussusception” from the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) of SMQ20000104: gastrointestinal perforation, ulcer, hemorrhage, obstruction non-specific findings/procedures; SMQ20000105: gastrointestinal obstruction; and SMQ20000107: gastrointestinal perforation. Among the 667, 729 reports in the JADER database submitted between April 2004 and November 2020, we identified 11,351 occurrences of DIGs. The reporting odds ratios (RORs) (95% confidence interval) of “barium sulfate containing X-ray media,” “drugs for treatment of hyperkalemia and hyperphosphatemia,” and “oral bowel cleanser” were 142.0 (127.1–158.6), 25.8 (23.1–28.8), and 29.7 (24.8–35.6), respectively. The median number of days (interquartile range) until the onset of an adverse event caused by each drug category was as follows: barium sulfate containing X-ray contrast media [2.0 (1.0–3.0)], diazepines, oxazepines, thiazepines, and oxepines [8.0 (8.0–18.5)], drugs for treatment of hyperkalemia and hyperphosphatemia [29.0 (8.0–55.0)], non-selective monoamine reuptake inhibitors [19.0 (7.0–47.5)], and oral bowel cleanser [0.0 (0.0–0.0)]. Depending on the drug, the time to onset of side effects ranged from days to several months. Our results highlighted the need to perform detailed monitoring of each drug for possible association with DIGs, which might otherwise have fatal consequences.

Risk Assessment for Anti-Infectives-Related Acute Kidney Injury Using the Japanese Adverse Drug Event Report Database

2020 ◽  
Author(s):  
Satoshi Nakao ◽  
Shiori Hasegawa ◽  
Ryogo Umetsu ◽  
Kazuyo Shimada ◽  
Ririka Mukai ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Adverse Drug Event ◽  
Association Rule ◽  
Association Rule Mining ◽  
Kidney Injury ◽  
Drug Event ◽  
Event Report ◽  
Rule Mining ◽  
Drug Induced ◽  
Medical Dictionary

Abstract Background: Acute kidney injury (AKI) is associated with significant increases in short- and long-term morbidity and mortality. Drug-induced AKI is a major concern in the present healthcare system. Our spontaneous reporting system (SRS) analysis assessed links between AKIs, along with patients’ age, as healthcare-associated risks and administered anti-infectives. We also generated anti-infectives-related AKI-onset profiles.Method: We calculated adjusted reporting odds ratios (RORs) for reports of anti-infectives-related AKIs (per Medical Dictionary for Regulatory Activities) in the Japanese Adverse Drug Event Report database and evaluated associations between anti-infectives and age by association rule mining. We evaluated time-to-onset data and hazard types using the Weibull parameter.Results: Among 534,688 reports (submission period: April 2004–June 2018), there were 21,727 AKI events. Anti-infective treatments including glycopeptide antibacterials, fluoroquinolones, third-generation cephalosporins, triazole derivatives, and carbapenems were associated with 596, 494, 341, 315, and 313 AKI incidences, respectively. Adjusted RORs of anti-infectives-related AKIs increased among older patients and were higher in anti-infective combination therapies [anti-infectives, ≥ 2; ROR, 2.75 (2.56–2.95)] than in monotherapies [ROR, 1.52 (1.45–1.61)]. In association rule mining, the number of anti-infectives and age were associated with anti-infectives-related AKI lift values (as consequent). Moreover, 48.1% of AKIs occurred within 5 days (median, 5.0 days) of anti-infective therapy initiation.Conclusion: Thus, adjusted RORs derived from our new SRS analysis indicate potential AKI risks linked to age and number of administered anti-infectives.

scholarly journals Evaluation of Drug-Induced Photosensitivity Using the Japanese Adverse Drug Event Report (JADER) Database

2017 ◽  
Vol 40 (12) ◽  
pp. 2158-2165 ◽  
Author(s):  
Satoshi Nakao ◽  
Haruna Hatahira ◽  
Sayaka Sasaoka ◽  
Shiori Hasegawa ◽  
Yumi Motooka ◽  
...  
Keyword(s):  
Adverse Drug Event ◽  
Drug Event ◽  
Event Report ◽  
Drug Induced

Evaluation of the Expression Profile of Antibiotic-Induced Thrombocytopenia Using the Japanese Adverse Drug Event Report Database

2021 ◽  
pp. 109158182110481
Author(s):  
Yuki Asai ◽  
Takanori Yamamoto ◽  
Yasuharu Abe
Keyword(s):  
Adverse Drug Event ◽  
Shape Parameter ◽  
Expression Profiles ◽  
Oral Treatment ◽  
Multiple Logistic Regression Analysis ◽  
Drug Event ◽  
Reporting Odds Ratio ◽  
Event Report ◽  
Drug Induced ◽  
Male Sex

Drug-induced thrombocytopenia (DITP) can be triggered by antibiotics; however, the details remain unclear. Here, we evaluated the expression profiles of DITP using the Japanese Adverse Drug Event Report (JADER) database. We analyzed reports of DITP between April 2004 and January 2021 from the JADER database. The reporting odds ratio (ROR) and 95% confidence interval (CI) were used to detect DITP signals. Factors thought to affect DITP, such as male sex and an age of at least 60 years, were added as covariates. We evaluated the time-to-onset profile and hazard type using the Weibull shape parameter. The JADER database contained 1,048,576 reports. Twelve of 60 antibiotics showed signals for DITP; the RORs (95% CIs) for ampicillin/sulbactam, ceftazidime, cefozopran, ciprofloxacin, fluconazole, fos-fluconazole, linezolid, pazufloxacin, piperacillin/tazobactam, teicoplanin, trimethoprim/sulfamethoxazole, and voriconazole were 1.75 (1.41-2.16), 1.77 (1.42-2.18), 1.35 (1.06-1.72), 2.56 (2.19-2.98), 1.93 (1.67-2.23), 2.08 (1.76-2.46), 5.29 (2.73-9.60), 1.92 (1.51-2.41), 1.54 (1.05-2.19), 1.47 (1.16-1.84), 1.92 (1.73-2.14), and 2.32 (1.59-3.30), respectively. In multiple logistic regression analysis, 7 and 6 antibiotics were detected for the factors age and male sex, respectively. The median times-to-onset of DITP for ciprofloxacin (oral treatment), fluconazole, linezolid, piperacillin/tazobactam, and trimethoprim/sulfamethoxazole were 91, 91, 11.5, 10, and 9 days, respectively. Furthermore, the 95% CI of the Weibull shape parameter β for these antibiotics was above and excluded 1, indicating that the antibiotics were the wear out failure type. We revealed the expression profiles of DITP following treatment with 12 antibiotics.

scholarly journals Analysis of drug-induced interstitial lung disease using the Japanese Adverse Drug Event Report database

2020 ◽  
Vol 8 ◽  
pp. 205031212091826 ◽  
Author(s):  
Kiyoka Matsumoto ◽  
Satoshi Nakao ◽  
Shiori Hasegawa ◽  
Toshinobu Matsui ◽  
Kazuyo Shimada ◽  
...  
Keyword(s):  
Interstitial Lung Disease ◽  
Lung Disease ◽  
Adverse Drug Event ◽  
Association Rule ◽  
Association Rule Mining ◽  
Drug Event ◽  
Event Report ◽  
Rule Mining ◽  
Drug Induced ◽  
Time To Onset

Objectives: Drug-induced interstitial lung disease occurs when exposure to a drug causes inflammation and, eventually, fibrosis of the lung interstitium. Drug-induced interstitial lung disease is associated with substantial morbidity and mortality. The aim of this retrospective study was to obtain new information on the time-to-onset profiles of drug-induced interstitial lung disease by consideration of other associated clinical factors using the Japanese Adverse Drug Event Report database. Methods: We identified and analyzed reports of drug-induced interstitial lung disease between 2004 and 2018 from the Japanese Adverse Drug Event Report database. The reporting odds ratio and 95% confidence interval was used to detect the signal for each drug-induced interstitial lung disease incidence. We evaluated the time-to-onset profile of drug-induced interstitial lung disease and used the applied association rule mining technique to uncover undetected relationships, such as possible risk factors. Results: The reporting odds ratios (95% confidence intervals) of drug-induced interstitial lung disease due to temsirolimus, gefitinib, sho-saiko-to, sai-rei-to, osimertinib, amiodarone, alectinib, erlotinib, everolimus, and bicalutamide were 18.3 (15.6–21.3), 17.8 (16.5–19.2), 16.3 (11.8–22.4), 14.5 (11.7–18.2), 12.5 (10.7–14.7), 10.9 (9.9–11.9), 10.6 (8.1–13.9), 9.6 (8.8–10.4), 9.4 (8.7–10.0), and 9.2 (7.9–10.6), respectively. The median durations (day (interquartile range)) for drug-induced interstitial lung disease were as follows: amiodarone (123.0 (27.0–400.5)), methotrexate (145.5 (67.8–475.8)), fluorouracil (86.0 (35.5–181.3)), gemcitabine (53.0 (20.0–83.0)), paclitaxel (52.0 (28.5–77.5)), docetaxel (47.0 (18.8–78.3)), bleomycin (92.0 (38.0–130.5)), oxaliplatin (45.0 (11.0–180.0)), nivolumab (56.0 (21.0–135.0)), gefitinib (24.0 (11.0–55.0)), erlotinib (21.0 (9.0–49.0)), temsirolimus (38.0 (14.0–68.5)), everolimus (56.0 (35.0–90.0)), osimertinib (51.5 (21.0–84.8)), alectinib (78.5 (44.3–145.8)), bicalutamide (50.0 (28.0–147.0)), pegylated interferon-2α (140.0 (75.8–233.0)), sai-rei-to (35.0 (20.0–54.5)), and sho-saiko-to (33.0 (13.5–74.0)) days. Association rule mining suggested that the risk of drug-induced interstitial lung disease was increased by a combination of amiodarone or sho-saiko-to and aging. Conclusion: Our results showed that patients who receive gefitinib or erlotinib should be closely monitored for the development of drug-induced interstitial lung disease within a short duration (4 weeks). In addition, elderly people who receive amiodarone or sho-saiko-to should be carefully monitored for the development of drug-induced interstitial lung disease.

scholarly journals Pharmacovigilance study of anti-infective-related acute kidney injury using the Japanese adverse drug event report database

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Satoshi Nakao ◽  
Shiori Hasegawa ◽  
Ryogo Umetsu ◽  
Kazuyo Shimada ◽  
Ririka Mukai ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Propensity Score ◽  
Combination Therapy ◽  
Adverse Drug Event ◽  
Kidney Injury ◽  
Drug Event ◽  
Event Report ◽  
Drug Induced ◽  
Medical Dictionary ◽  
Healthcare Associated

Abstract Background Acute kidney injury (AKI) is associated with significant increases in short- and long-term morbidity and mortality. Drug-induced AKI is a major concern in the present healthcare system. Our spontaneous reporting system (SRS) analysis assessed links between AKI, along with patients’ age, as healthcare-associated risks and administered anti-infectives. We also generated anti-infective-related AKI-onset profiles. Method We calculated reporting odds ratios (RORs) for reports of anti-infective-related AKI (per Medical Dictionary for Regulatory Activities) in the Japanese Adverse Drug Event Report database and evaluated the effect of anti-infective combination therapy. The background factors of cases with anti-infective monotherapy and combination therapy (≥ 2 anti-infectives) were matched using propensity score. We evaluated time-to-onset data and hazard types using the Weibull parameter. Results Among 534,688 reports (submission period: April 2004–June 2018), there were 21,727 AKI events. The reported number of AKI associated with glycopeptide antibacterials, fluoroquinolones, third-generation cephalosporins, triazole derivatives, and carbapenems were 596, 494, 341, 315, and 313, respectively. Crude RORs of anti-infective-related AKI increased among older patients and were higher in anti-infective combination therapies [anti-infectives, ≥ 2; ROR, 1.94 (1.80–2.09)] than in monotherapies [ROR, 1.29 (1.22–1.36)]. After propensity score matching, the adjusted RORs of anti-infective monotherapy and combination therapy (≥ 2 anti-infectives) were 0.67 (0.58–0.77) and 1.49 (1.29–1.71), respectively. Moreover, 48.1% of AKI occurred within 5 days (median, 5.0 days) of anti-infective therapy initiation. Conclusion RORs derived from our new SRS analysis indicate potential AKI risks and number of administered anti-infectives.

Sign in / Sign up

Export Citation Format

Share Document