Novel considerations on drug safety in epilepsy

Mifsud, Janet

doi:10.1080/14740338.2021.1865913

Cited by 2 publications

(2 citation statements)

References 14 publications

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“…Understanding the safety profile of AEDs is crucial due to the long-term pharmacotherapy required to control symptoms in patients with epilepsy. However, there is a limitation in using high-quality evidence on AED safety due to the lack of standardized reporting [20]. Therefore, our goal is to identify the major safety concerns associated with AEDs, including neurological, skin, and sexual/reproductive disorders.…”

Section: Discussionmentioning

confidence: 99%

“…Epilepsy is a chronic neurological disorder that requires long-term pharmacotherapy. Therefore, it is necessary to develop individual clinical strategies that take into account the safety profile of AEDs, as the possibility of adverse events inevitably increases [20]. This study aims to analyze the patterns of ADRs based on the mechanisms of action of AEDs, with a focus on major ADRs including neurological, dermatological, and sexual/reproductive disorders, using real-world data.…”

Section: Introductionmentioning

confidence: 99%

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A Real-World Safety Profile in Neurological, Skin, and Sexual disorders of Antiepileptic Drugs Using Pharmacovigilance Database of the Korea Adverse Event Reporting System (KAERS)

Kim,

Lee

2024

Preprint

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This study aims to examine the safety profile of antiepileptic drugs (AEDs) using real-world data, with a focus on neurological, skin, and sexual/reproductive disorders. Data were collected from AED-caused reports in the Korea Adverse Event Reporting System Database (KAERS-DB) from 2012 to 2022. Totally, 46,963 adverse drug reaction (ADR)-drug pairs were analyzed. At the system organ class level, the most frequently reported classes for sodium channel blockers (SCBs) were skin (37.9%), neurological (16.7%), and psychiatric disorders (9.7%). However, for non-SCBs, these were neurological (31.2%), gastrointestinal (22.0%), and psychiatric disorders (18.2%). The most common ADRs induced by SCBs were rash (17.8%), pruritus (8.2%), and dizziness (6.7%). In contrast, non-SCBs induced dizziness (23.7%), somnolence (13.0%), and nausea (6.3%). Among the most commonly reported ADRs, rash, pruritus, and urticaria occurred on average two days later with SCBs compared to non-SCBs. Sexual/reproductive disorders were reported at a frequency of 0.23%. SCBs were reported as the cause more frequently than non-SCBs (59.8% vs. 40.2%, Fisher’s exact test, p&lt;0.0001). Based on real-world data, we identified the safety profiles of AEDs. AED-induced ADRs exhibited different patterns depending on the mechanism. Therefore, it is important to establish different pharmacovigilance strategies to ensure proper monitoring.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A Real-World Safety Profile in Neurological, Skin, and Sexual disorders of Antiepileptic Drugs Using Pharmacovigilance Database of the Korea Adverse Event Reporting System (KAERS)

Kim,

Lee

2024

Preprint

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A Real-World Safety Profile in Neurological, Skin, and Sexual Disorders of Anti-Seizure Medications Using the Pharmacovigilance Database of the Korea Adverse Event Reporting System (KAERS)

Kim,

Lee

2024

JCM

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(1) Background: The utilization of high-quality evidence regarding the safety of anti-seizure medications (ASMs) is constrained by the absence of standardized reporting. This study aims to examine the safety profile of ASMs using real-world data. (2) Methods: The data were collected from the Korea Adverse Event Reporting System Database (KAERS-DB) between 2012 and 2021. In total, 46,963 adverse drug reaction (ADR)–drug pairs were analyzed. (3) Results: At the system organ class level, the most frequently reported classes for sodium channel blockers (SCBs) were skin (37.9%), neurological (16.7%), and psychiatric disorders (9.7%). For non-SCBs, these were neurological (31.2%), gastrointestinal (22.0%), and psychiatric disorders (18.2%). The most common ADRs induced by SCBs were rash (17.8%), pruritus (8.2%), and dizziness (6.7%). Non-SCBs were associated with dizziness (23.7%), somnolence (13.0%), and nausea (6.3%). Rash, pruritus, and urticaria occurred, on average, two days later with SCBs compared to non-SCBs. Sexual/reproductive disorders were reported at a frequency of 0.23%. SCBs were reported as the cause more frequently than non-SCBs (59.8% vs. 40.2%, Fisher’s exact test, p < 0.0001). (4) Conclusions: Based on real-world data, the safety profiles of ASMs were identified. The ADRs induced by SCBs exhibited different patterns when compared to those induced by non-SCBs.

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Novel considerations on drug safety in epilepsy

Cited by 2 publications

References 14 publications

A Real-World Safety Profile in Neurological, Skin, and Sexual disorders of Antiepileptic Drugs Using Pharmacovigilance Database of the Korea Adverse Event Reporting System (KAERS)

A Real-World Safety Profile in Neurological, Skin, and Sexual disorders of Antiepileptic Drugs Using Pharmacovigilance Database of the Korea Adverse Event Reporting System (KAERS)

A Real-World Safety Profile in Neurological, Skin, and Sexual Disorders of Anti-Seizure Medications Using the Pharmacovigilance Database of the Korea Adverse Event Reporting System (KAERS)

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