Severe drug eruptions due to lamotrigine in Japan based on data from the relief system of the Pharmaceuticals and Medical Devices Agency

• Published in: Allergology International Vol. 66; no. 1; pp. 156 - 158
• Main Authors: Saeki, Hidehisa, Yamada, Kazuo, Morikawa, Norifumi, Asahina, Akihiko, Ochiai, Toyoko, Iijima, Masafumi
• Format: Journal Article
• Language: English
• Published: England Elsevier B.V 01.01.2017; JAPANESE SOCIETY OF ALLERGOLOGY; Elsevier
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Child; Child, Preschool; Databases, Factual; Drug Eruptions - epidemiology; Female; Humans; Infant; Infant, Newborn; Japan - epidemiology; Male; Middle Aged; Retrospective Studies; Triazines - administration & dosage; Triazines - adverse effects
• ISSN: 1323-8930; 1440-1592
• DOI: 10.1016/j.alit.2016.07.006

Dear Editor, Lamotrigine (LTG) is one of the newer antiepileptic drugs (AED) and is also effective for the treatment of bipolar disorder. In Japan, LTG was first approved as add-on therapy for patients with recalcitrant epilepsy in 2008. It was approved for the suppression of recurrent/relapsed mood episodes in patients with bipolar disorder in 2011, and was also approved for monotherapy in epileptic patients in 2014. The primary safety concern with LTG is drug eruptions, with benign eruptions occurring in about 10% of patients and serious eruptions in about 0.1%. The incidence of drug eruptions is well recognized to be dose- and titration-dependent, and is related to concomitant use of valproic acid (VPA). Slow titration of LTG is known to markedly reduce the incidence of serious drug eruptions. Japan has a relief system for sufferers from adverse drug reactions (ADRs) managed by the Pharmaceuticals and Medical Devices Agency (PMDA). This system provides relief benefits for patients with diseases that require hospitalization caused by ADRs in the appropriate use of the drugs concerned.