Association between anaphylaxis and anti-influenza drug use: An analysis of the Japanese Adverse Drug Event Report database

Tanaka, Hiroyuki; Ohyama, Katsuhiro; Horikomi, Yui; Ishii, Toshihiro

doi:10.5582/ddt.2021.01053

Cited by 9 publications

(9 citation statements)

References 19 publications

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“…In this study, RORs and ICs were used for the signal detection of SREs as previously Flow diagram of the study. reported (14,15). RORs, ICs, and their 95% confidence intervals (CIs) were calculated using a two-by-two contingency table (Table 2) and equations as described below.…”

Section: Signal Detectionmentioning

confidence: 95%

“…However, as the World Health Organization, PMDA, and other regulatory authorities have suggested, it is possible to estimate the potential risk of adverse events associated with a target drug by calculating parameters such as reporting odds ratios (RORs) and information components (ICs) based on two-by-two contingency tables ( 12 ). In this study, RORs and ICs were used for the signal detection of SREs as previously reported ( 14 , 15 ). RORs, ICs, and their 95% confidence intervals (CIs) were calculated using a two-by-two contingency table ( Table 2 ) and equations as described below.…”

Section: Methodsmentioning

confidence: 99%

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A pharmacovigilance approach for assessing the occurrence of suicide-related events induced by antiepileptic drugs using the Japanese adverse drug event report database

et al. 2023

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Increased suicidality after antiepileptic drug (AED) treatment remains controversial. This study aimed to investigate the occurrence of suicide-related events (SREs) in Japan. SREs signals with AEDs used orally were evaluated by calculating reporting odds ratios (RORs) and information components (ICs) using the Japanese Adverse Drug Event Report (JADER) database from April 2004 to December 2021. Additionally, factors affecting the occurrence of SREs and time-to-onset from the initial AED treatment were analyzed. Of 22 AEDs, 12 (perampanel hydrate, nitrazepam, levetiracetam, clonazepam, clobazam, sodium valproate, phenobarbital, lamotrigine, lacosamide, gabapentin, zonisamide, and carbamazepine) showed signals of SREs. Patients in their 20 and 30 s, female sex, and concomitant use of multiple AEDs affected the occurrence of SREs. In six AEDs, the median time-to-onset of SREs in patients taking all AEDs was <100 days. The pharmacovigilance approach revealed that several AEDs displayed suicidality signals. Female patients, those in their 20 and 30 s, undergoing combination therapy with ≥2 AEDs, and patients early (<100 days from the initial treatment) in the course of AED therapy should be cautioned about SREs.

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Section: Signal Detectionmentioning

confidence: 95%

Section: Methodsmentioning

confidence: 99%

A pharmacovigilance approach for assessing the occurrence of suicide-related events induced by antiepileptic drugs using the Japanese adverse drug event report database

et al. 2023

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“…This study used ROR and IC to evaluate the signal detection of IOHs, as previously reported ( 9 , 10 ). The ROR is an AE signal index, the odds ratio of reporting a particular AE versus all other AEs associated with the target drugs, compared to the reporting odds for all other drugs.…”

Section: Methodsmentioning

confidence: 99%

Occurrence of intraocular hemorrhages under monotherapy or combination therapy of antiplatelets and anticoagulants using the Japanese Adverse Drug Event Report database

Tanaka¹,

Koseki²,

Sekido³

et al. 2023

J. pharm. pharm. sci.

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Purpose: An intraocular hemorrhage is an adverse event that can lead to visual acuity impairment. Antithrombotic therapy with antiplatelet agents and anticoagulants may increase intraocular hemorrhage. However, since their frequency is low, studies on the risk of intraocular hemorrhage with these drugs, especially under combination therapy, are limited. This study aimed to investigate the occurrence of intraocular hemorrhages under monotherapy and combination therapy with antiplatelets and anticoagulants by analyzing a large pharmacovigilance database.Methods: Intraocular hemorrhage signals with oral antiplatelets and anticoagulants were evaluated by calculating reporting odds ratios and information components using the Japan Adverse Drug Reactions Report database from April 2004 to March 2022. In addition, differences in signals between younger and elderly patients, affecting factors, and time-to-onset from initial antiplatelet and anticoagulant treatments were analyzed.Results: Aspirin, clopidogrel, warfarin, apixaban, and rivaroxaban, but not ticagrelor, ticlopidine, prasugrel, dabigatran, and edoxaban showed intraocular hemorrhage signals under monotherapy. In combination therapy, dual therapy (aspirin + P2Y12 inhibitors, warfarin, direct oral anticoagulants, and P2Y12 inhibitors + warfarin) and triple therapy (aspirin + P2Y12 inhibitors + warfarin) resulted in intraocular hemorrhage signals. Intraocular hemorrhage signals were observed in younger patients receiving monotherapy with aspirin and in elderly patients receiving monotherapy and combination therapy with warfarin. Affecting factors were diabetes mellitus in patients with prasugrel, use of medications for intravitreal injections, and posterior sub-Tenon injections with some antiplatelets and anticoagulants. The median period of intraocular hemorrhage occurrence after starting monotherapy with aspirin, clopidogrel, warfarin, or rivaroxaban was within 90 days.Conclusion: In addition to monotherapy with several antiplatelets and anticoagulants, combination therapy using aspirin, P2Y12 inhibitors, and warfarin has the potential risk of intraocular hemorrhage. Particular attention should be paid to the occurrence of intraocular hemorrhages in younger patients taking aspirin, in elderly patients taking warfarin, and within the first 90 days of antiplatelet and anticoagulant use.

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“…The calculations were performed using Excel for Microsoft 365 (Microsoft Corporation, Redmond, WA, USA). The safety signals for OARs were positive when the lower limit of the 95% CI of the ROR exceeded 1, and that of the IC exceeded 0 (17). III shows the results of the disproportionality analysis with anticancer drugs which showed RORs with the lower limit of the 95% CI >1 and that of IC >0 for each of the OARs.…”

Section: Ic Equationsmentioning

confidence: 99%

“…The Japanese Adverse Drug Event Report (JADER) is a nationwide database of spontaneous reports of ADR published by the Pharmaceuticals and Medical Devices Agency (PMDA), a pharmaceutical regulatory authority in Japan. The calculation of reporting odds ratio (RORs) and information components (ICs) (15)(16)(17)(18) based on safety signal data from JADER allows for the investigation of anticancer drug-induced OARs.…”

mentioning

confidence: 99%

Analyses of Ocular Adverse Reactions Associated With Anticancer Drugs Based on the Japanese Pharmacovigilance Database

et al. 2022

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Background/Aim: The systemic administration of anticancer drugs may cause ocular adverse reactions (OARs). However, such adverse events are generally rare and occur with an unknown frequency. This study aimed to investigate the tendency of occurrence of OARs induced by systemic anticancer drugs using a large spontaneous pharmacovigilance database in Japan. Patients and Methods: The safety signals for eight OARs (periorbital and eyelid, conjunctival, corneal, scleral, lacrimal, lens, retinal, and optic nerve disorders) and their associations with anticancer drugs were evaluated by analyzing reporting odds ratios (RORs) and information components (ICs) based on data from the Japanese Adverse Drug Event Report (JADER). Results: Safety signals associated with anticancer drugs were detected for periorbital and eyelid disorders (imatinib), conjunctival disorders (imatinib and lapatinib), corneal disorders (S-1, erlotinib, capecitabine, cetuximab, gefitinib, vandetanib, trastuzumab emtansine, lapatinib), lacrimal disorders (S-1, pembrolizumab), lens disorders (lenalidomide, pomalidomide, elotuzumab, tamoxifen, bexarotene, venetoclax), retinal disorders (encorafenib, binimetinib, tamoxifen, nabpaclitaxel, trametinib, dabrafenib), and optic nerve disorders (tamoxifen and blinatumomab). Some anticancer drugs showed differences in safety signals based on sex and age. Conclusion: Safety signals indicative of the risk of occurrence of OARs were observed for several anticancer drugs, and several hitherto unreported ocular adverse events requiring caution were also detected. Our results will help predict the occurrence of OARs by oncologists, ophthalmologists, pharmacists, and other healthcare professionals.

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Association between anaphylaxis and anti-influenza drug use: An analysis of the Japanese Adverse Drug Event Report database

Cited by 9 publications

References 19 publications

A pharmacovigilance approach for assessing the occurrence of suicide-related events induced by antiepileptic drugs using the Japanese adverse drug event report database

A pharmacovigilance approach for assessing the occurrence of suicide-related events induced by antiepileptic drugs using the Japanese adverse drug event report database

Occurrence of intraocular hemorrhages under monotherapy or combination therapy of antiplatelets and anticoagulants using the Japanese Adverse Drug Event Report database

Analyses of Ocular Adverse Reactions Associated With Anticancer Drugs Based on the Japanese Pharmacovigilance Database

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