Adverse Cutaneous Drug Reactions Associated with Old- and New- Generation Antiepileptic Drugs Using the Japanese Pharmacovigilance Database

Hosohata, Keiko; Inada, Ayaka; Oyama, Saki; Niinomi, Iku; Wakabayashi, Tomohito; Iwanaga, Kazunori

doi:10.1007/s40261-019-00754-z

Cited by 23 publications

(26 citation statements)

References 35 publications

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“…This finding is different from that of previous retrospective studies of epilepsy patients but similar to that of a pharmacovigilance study using spontaneous reporting. 2,7,16 Valproic acid was the most frequently prescribed AED in Korea based on the 2007 databases of National Health Insurance. 29…”

Section: Antiepileptic Drugs and Adverse Skin Reactionsmentioning

confidence: 99%

“…In case of zonisamide, the number of reports was low in contrast to that in previous studies. 2,7,16 In Korea, zonisamide is available only as a single original drug, and although it seems that the low number of prescriptions is one of the reasons for low adverse event reports, further investigation is needed to confirm this.…”

Section: Antiepileptic Drugs and Adverse Skin Reactionsmentioning

confidence: 99%

“…Epilepsy is one of the most common neurologic disorders, with a global prevalence of almost 50-60 million people and an annual incidence of 50 per 100,000 persons per year in developed countries. 1,2 Antiepileptic drug (AED) treatment is the most important means of preventing seizures, and two-thirds of patients with epilepsy become seizure free with appropriate pharmacotherapy. 3 However, more than 25% of patients discontinue treatment because of adverse effects of the initial AED chosen, and up to one-third are refractory to multiple AEDs; such cases may potentially lead to recurrent adverse drug reactions (ADRs) and drug interactions.…”

Section: Introductionmentioning

confidence: 99%

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Adverse Skin Reactions with Antiepileptic Drugs Using Korea Adverse Event Reporting System Database, 2008–2017

Kim

Bae

et al. 2020

J Korean Med Sci

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Background: Severe and life-threatening drug eruptions include drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). One class of medications that has been highly associated with such drug eruptions is antiepileptic drugs (AEDs). We attempt to investigate drug eruptions associated with AEDs as a class, as well as with individual AEDs, in Korea. Methods: We used the Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System (KIDS-KAERS) database, a nationwide database of adverse events reports, between January 2008 and December 2017 to investigate the reporting count of all drug eruptions and calculated the ratio of DRESS/SJS/TEN reports for each AED. Results: Among a total of 2,942 reports, most were of rash/urticaria (2,702, 91.8%), followed by those of DRESS (109, 3.7%), SJS (106, 3.6%), and TEN (25, 0.85%). The common causative AEDs were lamotrigine (699, 23.8%), valproic acid (677, 23%), carbamazepine (512, 17.4%), oxcarbazepine (320, 10.9%), levetiracetam (181, 6.2%), and phenytoin (158, 5.4%). In limited to severe drug eruptions (DRESS, SJS, and TEN; total 241 reports), the causative AEDs were carbamazepine (117, 48.8%), lamotrigine (57, 23.8%), valproic acid (20, 8.3%), phenytoin (15, 6.3%), and oxcarbazepine (10, 4.2%). When comparing aromatic AED with non-aromatic AED, aromatic AEDs were more likely to be associated with severe drug eruption (aromatic AEDs: 204/1,793 versus non-aromatic AEDs: 37/1,149; OR, 3.86; 95% CI, 2.7-5.5). Death was reported in 7 cases; DRESS was the most commonly reported adverse event (n = 5), and lamotrigine was the most common causative AED (n = 5). Conclusion: Although most cutaneous drug eruptions in this study were rash or urticaria, approximately 8% of reports were of severe or life-threatening adverse drug reactions, such as SJS, TEN, or DRESS. When hypersensitivity skin reactions occurred, aromatic AEDs were associated with 4 fold the risk of SJS/TEN/DRESS compared with non-aromatic AEDs. Our findings further emphasize that high risk AEDs should be prescribed under careful monitoring, and early detection and prompt interventions are needed to prevent severe complications.

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Section: Antiepileptic Drugs and Adverse Skin Reactionsmentioning

confidence: 99%

Section: Antiepileptic Drugs and Adverse Skin Reactionsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Adverse Skin Reactions with Antiepileptic Drugs Using Korea Adverse Event Reporting System Database, 2008–2017

Kim

Bae

et al. 2020

J Korean Med Sci

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“…This analysis is often used to investigate the association between drugs and SJS or TEN because both conditions are serious diseases, but they rarely occur. [14][15][16][17] However, although there have been several proposals for algorithms to detect the signals of concomitant use of two drugs, 18,19 there are no reports on the association between two-drug combination therapy and SJS or TEN. In this study, we investigated the signals of individual AEDs, AED combination therapies, and SJS/TEN using JADER as a spontaneous reporting system.…”

Section: Discussionmentioning

confidence: 99%

“…12,13 Several recent studies investigated AED-induced cases using spontaneous reporting systems. [14][15][16][17] However, despite the need for combination therapy in about 30% of patients with new-onset epilepsy, few studies have investigated the association between AED combination therapy and the occurrence of SJS or TEN.…”

Section: Introductionmentioning

confidence: 99%

Antiepileptic combination therapy with Stevens‐Johnson syndrome and toxic epidermal necrolysis: Analysis of a Japanese pharmacovigilance database

et al. 2020

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Objective: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are immune-mediated diseases characterized by an extensive loss of the epidermal skin layer, often resulting in death. SJS and TEN are often triggered by certain drugs, including antiepileptic drugs (AEDs). Epilepsy is very difficult to treat and often involves the combination of two or more AEDs. In this study, we quantified not only the risk of SJS or TEN associated with single-AED therapy but also the risk related to concomitant AED treatment using reporting-derived signals. Methods: An analysis of the Japanese Adverse Drug Event Report (JADER) database was performed from the first quarter of 2004 to the fourth quarter of 2018. The single-AED signals were evaluated using the proportional reporting ratio (PRR), and the combination therapy signals were evaluated using Ω shrinkage measure and combination risk ratio (CRR). Results: SJS signals were associated with 11 AEDs, and TEN signals were related to 12 AEDs. Moreover, the following AED combinations were associated with SJS signals: carbamazepine-lorazepam (Ω 025 : 0.33, CRR: 2.18) and fosphenytoin-lorazepam (Ω 025 : 0.99, CRR: 39.20). The TEN signals were related to the following combi

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Spontaneous and Immune Checkpoint Inhibitor-Induced Autoimmune Diseases: Analysis of Temporal Information by Using the Japanese Adverse Drug Event Report Database

et al. 2021

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Adverse Cutaneous Drug Reactions Associated with Old- and New- Generation Antiepileptic Drugs Using the Japanese Pharmacovigilance Database

Cited by 23 publications

References 35 publications

Adverse Skin Reactions with Antiepileptic Drugs Using Korea Adverse Event Reporting System Database, 2008–2017

Adverse Skin Reactions with Antiepileptic Drugs Using Korea Adverse Event Reporting System Database, 2008–2017

Antiepileptic combination therapy with Stevens‐Johnson syndrome and toxic epidermal necrolysis: Analysis of a Japanese pharmacovigilance database

Spontaneous and Immune Checkpoint Inhibitor-Induced Autoimmune Diseases: Analysis of Temporal Information by Using the Japanese Adverse Drug Event Report Database

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