Pharmacogenomics (PGx) has been utilized as a tool to improve a drug's benefit/risk ratio and the efficiency of drug developments. In order to examine what factors are involved to determine the level of contexts (contents and descriptions) of drug-PGx biomarker information, we graded sections of Japanese package inserts and US drug labels into six levels according to the importance of cautions in regards to clinical practice and compared similarities and differences of the contexts between the two countries. Out of 54 contexts identified, 33 (61%) were graded differently between Japan and the US. The different contexts were mainly related to metabolizing enzymes used in terms of safety, therapeutic areas other than oncology, outcome before 1993, Japan-based companies having marketing authorization and no PGx data on the Japanese population. We describe the potential reasons that could lead to the differences between the two countries such as genetic differences and quantitative evidence in the Japanese population, and also discuss future perspectives to improve PGx utilization in clinical practices in Japan.

Black dot ringworm (BDR), caused by Trichophyton violaceum var. glabrum (T. glabrum), was observed in a 28-year-old Japanese female who had been treated with prednisolone (22.5 mg/day) for systemic lupus erythematosus. It was successfully treated with oral terbinafine (125 mg/day) for 12 weeks. The causative fungus was identified by molecular analysis as well as morphological and biochemical examination. The chitin synthase 1 (CHS1) gene cleavage pattern of the clinical isolate with restricted enzyme HinfI was identical to that of T. violaceum. We reviewed previous reports of BDR to determine the historical trend of this infection in Japan. Since 1974, 93 Japanese cases have been reported. The age distribution was bi-modal: the higher peak consisted of children (aged 0-15 years), and the lower peak was composed of the elderly (aged 60-75 years). In the elderly group, females were predominant (M:F=1:22, p<0.001). T. violaceum, including T. glabrum, was identified as the most common causative fungus of BDR (75.3%). Sixty percent of cases showed slight erythema. In 8 families, 16 cases were found to be intrafamilial infections. A history of previous steroid treatment was described in about 40%.

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