{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,25]],"date-time":"2026-02-25T12:44:26Z","timestamp":1772023466340,"version":"3.50.1"},"reference-count":17,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2023,1,31]],"date-time":"2023-01-31T00:00:00Z","timestamp":1675123200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2023,4]]},"abstract":"<jats:p>Despite the requirement of routine blood tests during thiamazole treatment in Japan, granulocytopenia among patients treated with thiamazole has been occasionally reported to the Pharmaceuticals and Medical Devices Agency (PMDA). To characterize granulocytopenia in patients with thiamazole in Japan, the effects of routine blood tests were examined in a cohort of new users of thiamazole or propylthiouracil utilizing the MID\u2010NET. The occurrence of granulocytopenia (neutrophil count \u2264\u20091,500\/\u03bcL) in a given period was compared between patients with and without blood test results prior to the period. The trend in neutrophil count during thiamazole treatment was also compared between patients with and without granulocytopenia. A nested case\u2013control study based on the cohort was conducted to identify potential risk factors for granulocytopenia during thiamazole treatment. In the new user cohort including 4,371 patients treated with thiamazole, the occurrence of granulocytopenia in patients who had undergone blood tests at all previous periods was similar or higher than that among those who had not undergone blood test in all previous periods (e.g., adjusted odds ratio in period 2 was 1.63). The neutrophil count was relatively lower in the group of patients with granulocytopenia even before the occurrence of granulocytopenia. In a nested case\u2013control study, an upward tendency of the risk was observed when a patient was co\u2010prescribed anti\u2010arrhythmic drugs or antiulcer drugs with thiamazole. The characteristics of granulocytopenia during thiamazole treatment elucidated in this study should be recognized in clinical practice for the proper use of thiamazole.<\/jats:p>","DOI":"10.1002\/cpt.2850","type":"journal-article","created":{"date-parts":[[2023,1,17]],"date-time":"2023-01-17T13:28:00Z","timestamp":1673962080000},"page":"924-931","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Characterizing Granulocytopenia Associated with Thiamazole in Patients with Hyperthyroidism Based on Real\u2010World Data from the <scp>MID\u2010NET<\/scp> in Japan"],"prefix":"10.1111","volume":"113","author":[{"given":"Yuki","family":"Kinoshita","sequence":"first","affiliation":[{"name":"Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0570-2792","authenticated-orcid":false,"given":"Kazuhiro","family":"Kajiyama","sequence":"additional","affiliation":[{"name":"Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chieko","family":"Ishiguro","sequence":"additional","affiliation":[{"name":"Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1320-6190","authenticated-orcid":false,"given":"Takahiro","family":"Nonaka","sequence":"additional","affiliation":[{"name":"Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryota","family":"Kimura","sequence":"additional","affiliation":[{"name":"Office of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuki","family":"Kikuchi","sequence":"additional","affiliation":[{"name":"Office of Pharmacovigilance II, Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naoya","family":"Horiuchi","sequence":"additional","affiliation":[{"name":"Office of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toyotaka","family":"Iguchi","sequence":"additional","affiliation":[{"name":"Office of Pharmacovigilance II, Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0430-9887","authenticated-orcid":false,"given":"Yoshiaki","family":"Uyama","sequence":"additional","affiliation":[{"name":"Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,1,31]]},"reference":[{"key":"e_1_2_12_1_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra042972"},{"key":"e_1_2_12_2_1","unstructured":"Pharmaceuticals and Medical Devices Agency.Package Insert of MERCAZOLE INJECTION 10 mg [in Japanese]. <https:\/\/www.pmda.go.jp\/PmdaSearch\/iyakuDetail\/470007_2432400A1034_2_03#HDR_Warnings>. Accessed December 26 2022."},{"key":"e_1_2_12_3_1","unstructured":"Pharmaceuticals and Medical Devices Agency.Package Insert of MERCAZOLE TABLETS 2.5mg\/MERCAZOLE TABLETS 5\u2009mg [in Japanese]. <https:\/\/www.pmda.go.jp\/PmdaSearch\/iyakuDetail\/470007_2432001F1033_2_05#HDR_Warnings>. Accessed December 26 2022."},{"key":"e_1_2_12_4_1","unstructured":"Pharmaceuticals and Medical Devices Agency.PMDA Alert for Proper Use of Drugs (No. 5 December 2011):Periodic blood tests and symptom checks should be performed for prevention and early detection of agranulocytosis associated with the antithyroid drug thiamazole. <https:\/\/www.pmda.go.jp\/files\/000153926.pdf>. Accessed December 26 2022."},{"key":"e_1_2_12_5_1","unstructured":"Ministry of Health Labour and Welfare Act on securing quality efficacy and safety of products including pharmaceuticals and medical devices Japan<https:\/\/www.japaneselawtranslation.go.jp\/en\/laws\/view\/3213>. Accessed December 26 2022."},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1159\/000448586"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.1990.00390150107020"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1507\/endocrj.49.29"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1159\/000490384"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1089\/thy.2016.0229"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4879"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4777"},{"key":"e_1_2_12_13_1","unstructured":"Pharmaceuticals and Medical Devices Agency.Information for studies approved by the expert committee of MID\u2010NET\u00ae [in Japanese]. <https:\/\/www.pmda.go.jp\/safety\/mid\u2010net\/0010.html>. Accessed December 26 2022."},{"key":"e_1_2_12_14_1","unstructured":"Act on the Pharmaceuticals and Medical Devices Agency (Act No.192 of 2002). [in Japanese]. <https:\/\/elaws.e\u2010gov.go.jp\/document?lawid=414AC0000000192>. Accessed December 26 2022."},{"key":"e_1_2_12_15_1","unstructured":"Pharmaceuticals and Medical Devices Agency (PMDA).Pharmacoepidemiological studies for drug safety assessment under MIHARI framework(Japanese only). <https:\/\/www.pmda.go.jp\/safety\/surveillance\u2010analysis\/0045.html>. Accessed December 26 2022."},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2013-2569"},{"key":"e_1_2_12_17_1","volume-title":"The Treatment Guideline of Basedow's Disease 2019","author":"Japan Thyroid Association","year":"2019"}],"container-title":["Clinical Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.2850","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpt.2850","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.2850","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,7]],"date-time":"2023-11-07T13:32:05Z","timestamp":1699363925000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.2850"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,1,31]]},"references-count":17,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2023,4]]}},"alternative-id":["10.1002\/cpt.2850"],"URL":"https:\/\/doi.org\/10.1002\/cpt.2850","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,1,31]]},"assertion":[{"value":"2022-10-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-01-08","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-01-31","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}