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資料３－４ 研究報告の報告状況［920KB］ (17 ページ)
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| 出典情報 | 薬事審議会 医薬品等安全対策部会（令和7年度第4回 3／6）《厚生労働省》 |
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研究報告の報告状況
（2025年8月1日～2025年11月30日）
165
Prada D, et al. Evaluation of the evidence on acetaminophen
トラマドール塩酸塩・アセトアミノフェン
use and neurodevelopmental disorders using the Navigation
配合剤
Guide methodology. Environ Health. 2025; 24(1): 56-.
166 セルトラリン塩酸塩
Zhou Y, et al. Safety of antidepressants commonly used in 617-year-old children and adolescents: A disproportionality
analysis from 2014-2023 on the basis of the FAERS
database.. PLoS ONE. 2025; 20(8): e0330025-.
167 エスシタロプラムシュウ酸塩
Zhou Y, et al. Safety of antidepressants commonly used in 617-year-old children and adolescents: A disproportionality
analysis from 2014-2023 on the basis of the FAERS
database.. PLoS ONE. 2025; 20(8): e0330025-.
168 イブプロフェン含有一般用医薬品
Cristina Anamaria Buciuman. Pharmacovigilance Insights into
Ibuprofen's Neuropsychiatric Safety: A Retrospective
Analysis of EudraVigilance Reports. Pharmaceuticals (Basel)
.. 2025 Aug 29;18(9):1-21
169 セマグルチド（遺伝子組換え）
C Kai-Yang, et al. Does semaglutide increase the risk of
non-arteritic anterior ischemic optic neuropathy? A
systematic review and meta-analysis of emerging evidence.
Asia-Pacific Journal of Ophthalmology. 2025; 100245: DOI
http://dx.doi.org/10.1016/j.apjo.2025.100245
170 ドネペジル塩酸塩
Kim, M.J. et al. Exploration of drugs associated with the
development of bullous pemphigoid: A nationwide study. J.
Dermatol.. 2025; 52(8): 1304-1313.
171 乾燥ＢＣＧワクチン
Yaghi, Marita et al. Analysis of the potential for
immunosuppression of infants with in-utero and breast milk
exposure to antitumor necrosis factor alpha agents: are all
agents equally safe?. International Journal of Women's
Dermatology 11.3 (Oct 1, 2025): e220.
172 乾燥ＢＣＧワクチン
Amir Ali Hamidieh et al. Importance of BCG Vaccination at
birth in Pediatric Patients with Chronic Granulomatous
Disease after Hematopoietic Stem Cell Transplantation in
Developing Countries. Immunology letters (Sep 1, 2025):
107083.
173 トラネキサム酸
Salim HA, et al.. Tranexamic acid with surgery vs. surgery
alone for chronic subdural hematoma: Propensity scorematched analysis: Clinical neurology and neurosurgery.
2025;257: 109071
174 モンテルカストナトリウム
Tunca, Seda 1 ; Yilmaz, Ozge 1 ; Ocalan, Merve 1 ; Arga,
Mustafa 2 ; Cavkaytar, Ozlem 2 ; Ozceker, Deniz 3 ; Kilic,
Mehmet 4 ; Duksal, Fatma 5 ; Can, Demet 6 ; Sancakli,
Ozlem 6 ; Kaya, Mehmet ?irin 6. Potentially Overlooked
Risk for Neuropsychiatric Symptoms in Children:
Montelukast Treatment. Journal of paediatrics and child
health. 2025; 61(8): 1287-1294.
175 ボロファラン（１０Ｂ）
Zhang Yushu et al,Side effects of boron neutron capture
therapy Journal of Cancer Research and Therapeutics
21(4):p 777-786, September 2025.
17/31
（2025年8月1日～2025年11月30日）
165
Prada D, et al. Evaluation of the evidence on acetaminophen
トラマドール塩酸塩・アセトアミノフェン
use and neurodevelopmental disorders using the Navigation
配合剤
Guide methodology. Environ Health. 2025; 24(1): 56-.
166 セルトラリン塩酸塩
Zhou Y, et al. Safety of antidepressants commonly used in 617-year-old children and adolescents: A disproportionality
analysis from 2014-2023 on the basis of the FAERS
database.. PLoS ONE. 2025; 20(8): e0330025-.
167 エスシタロプラムシュウ酸塩
Zhou Y, et al. Safety of antidepressants commonly used in 617-year-old children and adolescents: A disproportionality
analysis from 2014-2023 on the basis of the FAERS
database.. PLoS ONE. 2025; 20(8): e0330025-.
168 イブプロフェン含有一般用医薬品
Cristina Anamaria Buciuman. Pharmacovigilance Insights into
Ibuprofen's Neuropsychiatric Safety: A Retrospective
Analysis of EudraVigilance Reports. Pharmaceuticals (Basel)
.. 2025 Aug 29;18(9):1-21
169 セマグルチド（遺伝子組換え）
C Kai-Yang, et al. Does semaglutide increase the risk of
non-arteritic anterior ischemic optic neuropathy? A
systematic review and meta-analysis of emerging evidence.
Asia-Pacific Journal of Ophthalmology. 2025; 100245: DOI
http://dx.doi.org/10.1016/j.apjo.2025.100245
170 ドネペジル塩酸塩
Kim, M.J. et al. Exploration of drugs associated with the
development of bullous pemphigoid: A nationwide study. J.
Dermatol.. 2025; 52(8): 1304-1313.
171 乾燥ＢＣＧワクチン
Yaghi, Marita et al. Analysis of the potential for
immunosuppression of infants with in-utero and breast milk
exposure to antitumor necrosis factor alpha agents: are all
agents equally safe?. International Journal of Women's
Dermatology 11.3 (Oct 1, 2025): e220.
172 乾燥ＢＣＧワクチン
Amir Ali Hamidieh et al. Importance of BCG Vaccination at
birth in Pediatric Patients with Chronic Granulomatous
Disease after Hematopoietic Stem Cell Transplantation in
Developing Countries. Immunology letters (Sep 1, 2025):
107083.
173 トラネキサム酸
Salim HA, et al.. Tranexamic acid with surgery vs. surgery
alone for chronic subdural hematoma: Propensity scorematched analysis: Clinical neurology and neurosurgery.
2025;257: 109071
174 モンテルカストナトリウム
Tunca, Seda 1 ; Yilmaz, Ozge 1 ; Ocalan, Merve 1 ; Arga,
Mustafa 2 ; Cavkaytar, Ozlem 2 ; Ozceker, Deniz 3 ; Kilic,
Mehmet 4 ; Duksal, Fatma 5 ; Can, Demet 6 ; Sancakli,
Ozlem 6 ; Kaya, Mehmet ?irin 6. Potentially Overlooked
Risk for Neuropsychiatric Symptoms in Children:
Montelukast Treatment. Journal of paediatrics and child
health. 2025; 61(8): 1287-1294.
175 ボロファラン（１０Ｂ）
Zhang Yushu et al,Side effects of boron neutron capture
therapy Journal of Cancer Research and Therapeutics
21(4):p 777-786, September 2025.
17/31