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A2595 - Analysis of Adverse Drug Events in Pulmonary Mycobacterium Avium Complex Disease Using the Japanese Adverse Drug Event Report (JADER) Database
Author Block: H. Namkoong1, Y. Takahashi2, M. Ishii1, T. Asakura3, S. Suzuki4, H. Kamata1, K. Yagi1, T. Betsuyaku1, K. Matsumoto2, J. Kizu2, N. Hasegawa5; 1Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine, Tokyo, Japan, 2Division of Practical Pharmacy, Keio University Faculty of Pharmacy, Tokyo, Japan, 3Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine, Shinjuku, Japan, 4Division of Pulomonary Medicine, Department of Medicine, Keio University School of Medicine, Shinjuku, Japan, 5Center for Infectious Diseases and Infection Control, Keio Universtity School of Medicine, Tokyo, Japan.
Introduction:
The incidence of pulmonary nontuberculous mycobacterial (NTM) disease has been increasing globally. Patients with pulmonary NTM disease receiving antimicrobial chemotherapy often experience adverse drug events, resulting in chemotherapy interruption and treatment failure. To improve treatment outcomes of pulmonary NTM disease, it is essential to grasp the perspectives of adverse drug events. However, their details are not fully understood thus far. Recently, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has released the Japanese Adverse Drug Event Report (JADER) database, which is a large, public, spontaneous reporting system. It is thought to reflect current clinical practice in Japan, and an increasing number of clinical studies implementing the JADER database has been reported in the fields of various diseases.
Objectives:
To clarify adverse drug events in pulmonary Mycobacterium avium complex (MAC) disease treatment.
Methods:
Adverse events recorded between April 2004 and March 2014 in the JADER database were obtained from the PMDA website (www.pmda.go.jp).
Results:
During the observation period, 6360 adverse events (638 patients) regarding pulmonary MAC disease were extracted. Among all adverse events, ocular toxicity (100 patients), blood and lymphatic system disorders (97 patients), abnormal laboratory findings (92 patients), and hepatobiliary disorders (89 patients) were frequently reported. Among those who received antimicrobial chemotherapy, adverse events (64 events) of ethambutol (EB) were frequently reported, while those of clarithromycin (27 events) and rifampicin (25 events) were reported less frequently. Regarding emergence times, the adverse events of EB showed a bimodal distribution: at three months and at six months or later after treatment initiation. The adverse events of clarithromycin and rifampicin occurred mostly within three months after treatment initiation. Additionally, ocular toxicity due to EB tended to show unrecoverable outcomes.
Conclusions:
In antimicrobial chemotherapy against pulmonary MAC disease, it is important to pay attention to ocular toxicity due to EB, which occurs six months or later after treatment initiation, in addition to adverse events appearing at the early stage.