Cutaneous adverse drug reaction of antiepileptic drugs with pharmacovigilance of the Korea Adverse Event Reporting System
Antiepileptic drugs (AEDs) have common adverse drug reactions including skin reactions. The drugs can induce severe cutaneous adverse reactions such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). This study aimed to analyze the cutaneous adverse drug reaction (ADR) of AEDs using the database of the Korea Adverse Event Reporting System (KAERS). The KAERS data of adverse events reported related to AEDs from 2011 to 2021 were analyzed for the type of drugs, characteristics, and numbers of cutaneous ADR, specifically. The cutaneous ADRs were assessed for the reporting odds ratios (RORs) with 95% confidence intervals (CIs). The total number of pairs of AEDs-ADR was 46,963 during the study period. The cutaneous ADRs were 8,438 cases which were the second most frequent to the most frequent ADR with the central nervous system, 12,484 cases among the system organ class-based ADRs. The AEDs with causality were 66.7% of sodium channel blockers (SCBs) and 33.3% of non-SCBs. The ROR with 95% CI of SCB drugs were carbamazepine (4.22; 3.91-4.54), oxcarbazepine (6.44; 5.79–7.16), phenytoin (3.41; 2.97-3.91), and valproate (1.74; 1.61-1.87). The ROR of non-SCBs were levetiracetam (1.93; 1.78-2.09), and phenobarbital (4.62; 3.58- 5.96). The onset time of rash, pruritis, and urticaria was delayed in 2 days with SCBs. The SJS/TEN was detected as the ADR signal with carbamazepine, lamotrigine, phenytoin, valproate, and phenobarbital. In conclusion, SCBs were the major drugs causing the cutaneous ADRs in the KAERS data. Severe SJS and TEN were also reported and efforts are required for careful observation and prevention of serious ADRs.
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