scholarly journals Angioedema Caused by Drugs That Prevent the Degradation of Vasoactive Peptides: A Pharmacovigilance Database Study

2021 ◽  
Vol 10 (23) ◽  
pp. 5507
Author(s):  
Yoshihiro Noguchi ◽  
Azusa Murayama ◽  
Hiroki Esaki ◽  
Mayuko Sugioka ◽  
Aisa Koyama ◽  
...  
Keyword(s):  
Substance P ◽  
Ace Inhibitors ◽  
Ace Inhibitor ◽  
Drug Event ◽  
Event Report ◽  
Disproportionality Analysis ◽  
Drug Induced ◽  
Dipeptidyl Peptidase 4 ◽  
Vasoactive Peptides ◽  
Pharmacovigilance Database

Angioedema results from the decreased degradation of vasoactive peptides such as substance P and bradykinin. In this study, we sought to clarify whether dipeptidyl peptidase-4 (DPP-4) and angiotensin-converting enzyme (ACE) inhibitors that suppress the degradation of substance P and bradykinin are involved in angioedema onset. We calculated information coefficients (ICs) by performing a disproportionality analysis to evaluate DPP-4/ACE inhibitor-induced angioedema using the Japanese Adverse Drug Event Report (JADER) database. No angioedema signals were detected for DPP-4 inhibitors; however, a signal was detected for ACE inhibitors (IC: 2.42, 95% confidence interval (CI): 2.19 to 2.65). Of the patients treated with DPP-4 inhibitors, four developed drug-induced angioedema in combination with ACE inhibitors, and all were taking vildagliptin. Signals were detected for enalapril (IC: 2.39, 95% CI: 2.06 to 2.71), imidapril (IC: 2.83, 95% CI: 2.38 to 3.27), lisinopril (IC: 2.28, 95% CI: 1.55 to 3.00), temocapril (IC: 1.35, 95% CI: 0.29 to 2.40), and trandolapril (IC: 1.57, 95% CI: 0.19 to 2.95). Both inhibitors inhibited the degradation of substance P and bradykinin and were thus expected to cause angioedema. However, no signal of angioedema was detected with the DPP-4 inhibitors, in contrast to some ACE inhibitors. This study found that ACE inhibitors and DPP-4 inhibitors, which inhibit the degradation of substance P and bradykinin, tended to have different effects on the onset of angioedema in clinical practice.

scholarly journals Pharmacovigilance Assessment of Drug-Induced Acute Pancreatitis Using a Spontaneous Reporting Database

2019 ◽  
Vol 38 (6) ◽  
pp. 487-492 ◽  
Author(s):  
Iku Niinomi ◽  
Keiko Hosohata ◽  
Saki Oyama ◽  
Ayaka Inada ◽  
Tomohito Wakabayashi ◽  
...  
Keyword(s):  
Acute Pancreatitis ◽  
Odds Ratio ◽  
Spontaneous Reporting ◽  
Adverse Drug Events ◽  
Drug Event ◽  
Reporting Odds Ratio ◽  
Event Report ◽  
Disproportionality Analysis ◽  
Drug Induced ◽  
Spontaneous Reporting Database

Background: Acute pancreatitis (AP) is associated with risks of morbidity and mortality. The incidence of AP recently increased compared to that traditionally reported in the literature. Objective: The purpose of this study was to evaluate the possible association between AP and drugs using the Japanese Adverse Drug Event Report (JADER) database, which is a spontaneous reporting database of adverse drug events. Methods: Adverse event reports submitted to the JADER database between 2004 and 2017 were analyzed. Disproportionality analysis was performed by calculating the reporting odds ratio (ROR) with 95% confidence intervals for signal detection. Results: A total of 3,443 reports (0.17% of all adverse events) were identified as drug-induced AP, in which 431 different drugs were involved. Acute pancreatitis was frequently reported in men (58.5%) in their 60s (19.1%); 40.6% developed AP within 4 weeks after the treatment. Among the most frequently reported drugs, signals were detected for prednisolone, ribavirin, sitagliptin, mesalazine, tacrolimus, and l-asparaginase, which are well-known causes of AP. Telaprevir, donepezil, and ustekinumab also generated signals. As for drugs with high RORs, l-asparaginase and alogliptin were noteworthy. Conclusion: Most of the identified drugs were already known to induce AP, but the likelihood of the reporting of AP varied among the drugs. Our results should raise physicians’ awareness of drugs associated with AP, but further investigation of these medications is warranted.

Drug-induced neuropsychiatric adverse events using post-marketing surveillance

2021 ◽  
Vol 16 ◽  
Author(s):  
Tomohito Wakabayashi ◽  
Takahiro Nakatsuji ◽  
Hiroko Kambara ◽  
Iku Niinomi ◽  
Saki Oyama ◽  
...  
Keyword(s):  
Spontaneous Reporting ◽  
Abnormal Behavior ◽  
Drug Event ◽  
Reporting Odds Ratio ◽  
Neuraminidase Inhibitors ◽  
Disproportionality Analysis ◽  
Drug Induced ◽  
Real World Setting ◽  
Post Marketing Surveillance ◽  
Post Marketing

Background: Several studies reported that abnormal behavior was noted in pediatric patients receiving several drugs including neuraminidase inhibitors (NIs). However, information on drugs associated with abnormal behavior in a real-world setting remains limited. The purpose of this study was to clarify drugs associated with abnormal behavior using a spontaneous reporting system database. Methods: We performed a retrospective pharmacovigilance disproportionality analysis using the Japanese Adverse Drug Event Report database. Adverse event reports submitted to the Pharmaceuticals and Medical Devices Agency were analyzed. Drug associated with abnormal behavior were estimated using disproportionality analysis with calculation of the reporting odds ratio and 95% confidence interval. Results: A total of 1,144 reports of abnormal behavior were identified. Signals were detected showing the association of 4 including neuraminidase inhibitors (oseltamivir, zanamivir, laninamivir, and peramivir) with abnormal behavior, and these signals were stronger for oseltamivir than other neuraminidase inhibitors. Signals were also detected for acetaminophen and montelukast. Conclusion: Our results should raise physicians’ awareness of drugs associated with abnormal behavior, but further investigation of these medications is warranted.

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.

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