18 < Relevant articles > PubMed Kinoshita, Y., Kajiyama, K., Ishiguro, C., Nonaka, T., Kimura, R., Kikuchi, Y., Horiuchi, N., Iguchi, T. & Uyama, Y. Characterizing granulocytopenia associated with thiamazole in patients with hyperthyroidism based on real-world data from the MID-NET® in Japan. Clin Pharmacol Ther 113, 924-31 (2023). 10.1002/cpt.2850 < Background > Granulocytopenia including agranulocytosis is known as an important adverse event caused by thiamazole, which is used for the treatment of hyperthyroidism. For the purpose of early detection and prevention of more serious granulocytopenia caused by thiamazole, a precaution has been issued to conduct routine blood tests during treatment granulocytopenia have been reported after administration of thiamazole, the appropriateness of the contents of the precautions was examined. < Outline> In patients prescribed thiamazole, the association between the implementation status of the routine tests and the occurrence of granulocytopenia was evaluated utilizing the MID-NET®, a medical information database managed and operated by PMDA. MID-NET® contains the results of various laboratory tests including neutrophil count, which can be used for various investigations. The occurrence of granulocytopenia (neutrophil count ≤ 1,500/μL) in a given period was compared between patients prescribed thiamazole with and without the routine tests to determine whether the routine tests can prevent the occurrence of granulocytopenia. As a result, granulocytopenia was observed to a certain degree even in the patients having the routine tests, and the occurrence did not tend to be lower than that in the patients granulocytopenia or the prevention of aggravation (See Table: age and sex adjusted odds ratio). This may be explained by the fact that patients who underwent the routine tests had some risk factors for granulocytopenia compared to those However, in the patients who experienced granulocytopenia during the period from Day 43 to Day 56 after thiamazole the occurrence date of granulocytopenia. Therefore, routine tests in some patients may help detect the trend of the occurrence of granulocytopenia early. Although the results of this study did not provide clear findings that routine tests contributed to early detection of granulocytopenia and prevention of its aggravation, it would lead to early detection of granulocytopenia and prevention of its aggravation in some patients. Therefore, we concluded that routine tests have a certain significance as a precaution. Office of Pharmacovigilance I, Yuki Kinoshita with thiamazole (once every 2 weeks for the first 2 months of treatment, and on a regular basis thereafter.) for monitoring a decreasing trend in granulocyte count. However, since a certain number of serious cases of without the routine tests. There was no finding that routine blood tests necessarily contributed to the early detection of without the routine tests, suggesting that the patients with the routine tests had more substantial need for testing. was prescribed (Period 4), neutrophil counts tended to gradually decrease from first prescription date of thiamazole to Characterizing granulocytopenia associated with thiamazole in patients with hyperthyroidism based on real-world data from the MID-NET® in Japan
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