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

Noguchi, Yoshihiro; Takaoka, Mirai; Hayashi, Tsuyoshi; Tachi, Tomoya; Teramachi, Hitomi

doi:10.1111/epi.16626

Cited by 23 publications

(12 citation statements)

References 41 publications

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“…In addition, the child was given fluid replacement, intravenous antibiotics, and daily wound care; and discharged home improved. Epilepsy is a common neurological disorder in sub-Saharan Africa; epilepsy is characterized as a chronic condition of recurrent unprovoked seizures [1,15,18,21]. Antiepileptic drugs (AEDs) are vital in controlling the seizure attaché in epileptic patients.…”

Section: Discussionmentioning

confidence: 99%

“…Antiepileptic drugs (AEDs) are vital in controlling the seizure attaché in epileptic patients. Thus, it's important for the clinicians to be familiar with AEDs associated with highest incidences of TEN/SJS; these include: carbamazepine, lamotrigine, phenobarbital, phenytoin and valproic acid [1,15,18,21]. Therefore, before prescribing these AEDs, it is important to ask history of drug allergy, atopic history, and family history of allergy; to avoid occurrence of delayed hypersensitivity reactions such as TEN.…”

Section: Discussionmentioning

confidence: 99%

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Toxic epidermal necrosis associated with phenobarbitone: a case report and brief review of the literatures

Ayele

Ali

Mulatu

2021

Allergy Asthma Clin Immunol

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Background Toxic epidermal necrolysis (TEN)/Stevens–Johnson syndrome (SJS) is the spectrum of severe, acute, mucocutaneous, T-cell mediated delayed type IV hypersensitivity reaction and universally related to different drugs. Phenobarbitone is known to cause hypersensitivity reactions with benign pattern; ranging from a mild to moderate rashes but not life-threatening reactions such as TEN/SJS. Case report We report a 14-year-old asthmatic male patient admitted to a local hospital for an acute exacerbation of asthma, after he presented with shortness of breath, cough, and fever. He was treated with bronchodilator and antibiotics. On subsequent days, the patient developed new onset generalized tonic clonic seizure in the hospital for which he was started on phenobarbitone of 100 mg twice daily. Two weeks after initiation of phenobarbitone, the patient developed extensive blistering skin eruptions; which subsequently exfoliated unevenly. Associated with the hypersensitivity skin reaction, the patient reported low grade fever, sore throat, and dysphagia. The exfoliation also involved oral and conjunctival mucosa; with estimated 65% body surface area involvement. The laboratory investigations were relevant for mild leucocytosis, prolonged prothrombin time, and reduced albumin. Phenobarbitone was discontinued and replaced with clonazepam; and the patient was managed with fluids replacement, IV antibiotics, twice daily wound care, analgesics, and naso gastric tube feeding. On subsequent days the patients’ clinical condition started improving; the skin lesion also started to heal and exfoliate in most of the affected skin surface areas, and the patient was discharged improved after ten days of intensive care unit. Conclusion In summary, the present case describes, a 14-years-old young child with history of asthma and seizure disorder; and developed toxic epidermal necrosis following exposure to Phenobarbitone. This case also highlighted the better prognosis observed in pediatric population with TEN.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Toxic epidermal necrosis associated with phenobarbitone: a case report and brief review of the literatures

Ayele

Ali

Mulatu

2021

Allergy Asthma Clin Immunol

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“…On the other hand, there are some combinations that have not yet been reported. Recently, we used the Ω shrinkage measure model to report potential drug combinations for the onset of SJS in concomitant use with antiepileptic drugs [21]. Not all AEs have been identified and there are still many unknown AEs.…”

Section: Discussionmentioning

confidence: 99%

Subset Analysis for Screening Drug–Drug Interaction Signal Using Pharmacovigilance Database

2020

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Many patients require multi-drug combinations, and adverse event profiles reflect not only the effects of individual drugs but also drug–drug interactions. Although there are several algorithms for detecting drug–drug interaction signals, a simple analysis model is required for early detection of adverse events. Recently, there have been reports of detecting signals of drug–drug interactions using subset analysis, but appropriate detection criterion may not have been used. In this study, we presented and verified an appropriate criterion. The data source used was the Japanese Adverse Drug Event Report (JADER) database; “hypothetical” true data were generated through a combination of signals detected by three detection algorithms. The accuracy of the signal detection of the analytic model under investigation was verified using indicators used in machine learning. The newly proposed subset analysis confirmed that the signal detection was improved, compared with signal detection in the previous subset analysis, on the basis of the indicators of Accuracy (0.584 to 0.809), Precision (= Positive predictive value; PPV) (0.302 to 0.596), Specificity (0.583 to 0.878), Youden’s index (0.170 to 0.465), F-measure (0.399 to 0.592), and Negative predictive value (NPV) (0.821 to 0.874). The previous subset analysis detected many false drug–drug interaction signals. Although the newly proposed subset analysis provides slightly lower detection accuracy for drug–drug interaction signals compared to signals compared to the Ω shrinkage measure model, the criteria used in the newly subset analysis significantly reduced the amount of falsely detected signals found in the previous subset analysis.

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“…This study defined a conservative signal detection algorithm as one that detects few signals that are specific to that detection algorithm, and many signals that are common to other algorithms. Surprisingly, however, there have only been few papers using the Ω shrinkage measure [17]; rather, several reports have used a detection method that extends the reporting odds ratio (ROR) score [18][19][20]. In addition, there is also a report that evaluated the ROR score of the concomitant use [21].…”

Section: Introductionmentioning

confidence: 99%

Verification of the “Upward Variation in the Reporting Odds Ratio Scores” to Detect the Signals of Drug–Drug Interactions

et al. 2021

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The reporting odds ratio (ROR) is easy to calculate, and there have been several examples of its use because of its potential to speed up the detection of drug–drug interaction signals by using the “upward variation of ROR score.” However, since the validity of the detection method is unknown, this study followed previous studies to investigate the detection trend. The statistics models (the Ω shrinkage measure and the “upward variation of ROR score”) were compared using the verification dataset created from the Japanese Adverse Drug Event Report database (JADER). The drugs registered as “suspect drugs” in the verification dataset were considered as the drugs to be investigated, and the target adverse event in this study was Stevens–Johnson syndrome (SJS), as in previous studies. Of 3924 pairs that reported SJS, the number of positive signals detected by the Ω shrinkage measure and the “upward variation of ROR score” (Model 1, the Susuta Model, and Model 2) was 712, 2,112, 1758, and 637, respectively. Furthermore, 1239 positive signals were detected when the Haldane–Anscombe 1/2 correction was applied to Model 2, the statistical model that showed the most conservative detection trend. This result indicated the instability of the positive signal detected in Model 2. The ROR scores based on the frequency-based statistics are easily inflated; thus, the use of the “upward variation of ROR scores” to search for drug–drug interaction signals increases the likelihood of false-positive signal detection. Consequently, the active use of the “upward variation of ROR scores” is not recommended, despite the existence of the Ω shrinkage measure, which shows a conservative detection trend.

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

Cited by 23 publications

References 41 publications

Toxic epidermal necrosis associated with phenobarbitone: a case report and brief review of the literatures

Toxic epidermal necrosis associated with phenobarbitone: a case report and brief review of the literatures

Subset Analysis for Screening Drug–Drug Interaction Signal Using Pharmacovigilance Database

Verification of the “Upward Variation in the Reporting Odds Ratio Scores” to Detect the Signals of Drug–Drug Interactions

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