資料
カルバマゼピンとラモトリギンが関連した副作用の現状調査:
「副作用が疑われる症例報告に関する情報」, 「副作用救済給付の決定に関する情報」と 「レセプト情報・特定健診等情報データベース」による解析
2017 年 19 巻 2 号 p. 72-81
詳細
2017 年 19 巻 2 号 p. 72-81
Objective: We previously showed that interstitial lung disease, pneumonia, abnormal liver function, and anaphylactic reactions were frequent adverse events, and we analyzed outcomes, suspected causative drugs, and the onset of adverse events using information derived from the “Japanese Adverse Drug Event Report” (JADER) database. Here, we aimed to determine the status of actual adverse reactions to carbamazepine (CBZ) and lamotrigine (LTG) using national public databases.
Methods: Data from the “Information on Decision on Payment/non-payment of Adverse Reaction Relief Benefits” (IARRB; April 2012-March 2016) and JADER (April 2012-March 2016) databases were downloaded from the website of the Pharmaceuticals and Medical Devices Agency. Information from the national database of the “Health Insurance Claims and Specific Health Checkups of Japan” (NDB) (April 2014-March 2015) was downloaded from the website of the Ministry of Health, Labour and Welfare.
Results: The numbers of females and males in the IARRB were 169 and 229, respectively, for CBZ and 135 and 56, respectively, for LTG. Those in JADER were 1,152 and 1,352, respectively, for CBZ and 1,358 and 806, respectively, for LTG. The respective ratios of males and females prescribed CBZ and LTG in the NDB were 46.2 and 53.8%, and 56.3 and 43.7%, respectively. Both CBZ and LTG were identified as very high-risk drugs associated with extreme skin reactions such as drug-induced hypersensitivity syndrome (DIHS), toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), erythema multiforme type drug eruption (EM), and disseminated papuloerythematous drug eruption (DPE). CBZ induced DIHS, EM, and DPE more frequently among elderly men (over 60 years old), whereas LTG induced these reactions in women of reproductive age.
Conclusions: Elderly men prescribed CBZ and women of reproductive age prescribed LTG should be advised about extreme adverse skin reactions.
