Division of Neurology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
Pharmacovigilance Section, Centre of Compliance and Quality Control, National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health, Kuala Lumpur, Malaysia.
J Clin Pharmacol. 2022 Aug;62(8):983-991. doi: 10.1002/jcph.2040. Epub 2022 Mar 29.
Antiseizure medication can potentially cause severe cutaneous adverse reactions, and certain antiseizure medication-induced severe cutaneous adverse reactions are associated with specific human leukocyte antigen alleles. This caused a change in antiseizure medication prescribing patterns, which may influence the incidence of antiseizure medication-induced severe cutaneous adverse reactions. Thus, we aimed to determine the incidence of antiseizure medication-induced severe cutaneous adverse reactions and its change over 15 years (2006-2019) in Malaysia. This retrospective analysis combined antiseizure medication-induced SCAR cases from the national adverse drug reaction database in the National Pharmaceutical Regulatory Agency, antiseizure medication usage data from the Malaysian Statistics of Medicine, and prescribing data from University Malaya Medical Centre, a national-level tertiary hospital to calculate antiseizure medication-induced SCAR incidence in Malaysia. We observed an upward trend in reported antiseizure medication-induced SCAR cases from 28 cases in 2006 to 92 in 2016. The incidence of carbamazepine (CBZ)-induced severe cutaneous adverse reactions increased from 7.5 per 1000 person-years (2006) to 17.8 per 1000 person-years (2016) but dropped to 7.2 per 1000 person-years subsequently (2019). Concurrently, there was an increase in the incidence of severe cutaneous adverse reactions secondary to phenytoin and lamotrigine. The prevalent users of CBZ had reduced from 22.8% (2006) to 14.1% (2016), whereas the levetiracetam and sodium valproate users increased by 5.5% and 4.8%, respectively. The incidence of CBZ-induced severe cutaneous adverse reactions had reduced since 2016, probably related to the implementation of human leukocyte antigen-B*1502 screening in Malaysia or substitution of CBZ with other antiseizure medications. However, this was accompanied by an increase in SCAR incidence related to phenytoin and lamotrigine.
抗癫痫药物可能会导致严重的皮肤不良反应，某些抗癫痫药物引起的严重皮肤不良反应与特定的人类白细胞抗原等位基因有关。这导致了抗癫痫药物处方模式的改变，可能会影响抗癫痫药物引起的严重皮肤不良反应的发生率。因此，我们旨在确定 15 年来（2006-2019 年）在马来西亚抗癫痫药物引起的严重皮肤不良反应的发生率及其变化。这项回顾性分析结合了国家药物不良反应数据库中的抗癫痫药物引起的 SCAR 病例、马来西亚医药统计中的抗癫痫药物使用数据以及马来亚大学医学中心的处方数据，以计算马来西亚抗癫痫药物引起的 SCAR 发生率。我们观察到报告的抗癫痫药物引起的 SCAR 病例从 2006 年的 28 例呈上升趋势，到 2016 年增加到 92 例。卡马西平（CBZ）引起的严重皮肤不良反应的发生率从 2006 年的每 1000 人年 7.5 例增加到 2016 年的每 1000 人年 17.8 例，但随后降至 2019 年的每 1000 人年 7.2 例。同时，苯妥英和拉莫三嗪引起的严重皮肤不良反应发生率有所增加。CBZ 的主要使用者从 2006 年的 22.8%降至 2016 年的 14.1%，而左乙拉西坦和丙戊酸钠的使用者分别增加了 5.5%和 4.8%。自 2016 年以来，CBZ 引起的严重皮肤不良反应发生率有所下降，这可能与马来西亚实施人类白细胞抗原-B*1502 筛查或用其他抗癫痫药物替代 CBZ 有关。然而，这伴随着与苯妥英和拉莫三嗪相关的 SCAR 发生率的增加。
