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資料３－４ 研究報告の報告状況［877KB］ (6 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6年度第1回 6／19）《厚生労働省》 |
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研究報告の報告状況
（2023年12月1日～2024年3月31日）
タクロリムス水和物
97 ボルテゾミブ
ペメトレキセドナトリウム水和物
98 ゾルピデム酒石酸塩
99
モルヒネ塩酸塩水和物
モルヒネ硫酸塩水和物
100 ゲーファピキサントクエン酸塩
101 トラマドール塩酸塩・アセトアミノフェン配合剤
102 アモキシシリン水和物
パロキセチン塩酸塩水和物
メトクロプラミド
103 塩酸メトクロプラミド
オランザピン
リスペリドン
104 アセトアミノフェン
105 クロピドグレル硫酸塩
モルヒネ塩酸塩水和物
アヘン
106 アヘンチンキ
アヘン・トコン
アヘンアルカロイド塩酸塩
Largeau, B. et al. (CHU Tours, Tours, France). Thrombotic microangiopathy
associated with anticancer and immune system targeting drugs: New insights
from real-world data using the WHO pharmacovigilance database. J. Intern.
Med.. 2023; 294(5): 665-678-.
Mekkawy KL, et al. Immediate Postoperative Zolpidem Use Increases Risk of
Falls and Implant Complication Rates Following Total Hip Arthroplasty: A
Retrospective Case-Control Analysis. J Arthroplasty ; 39(1.0): * 169173.e1.
Smith BL, et al.. Perinatal morphine but not buprenorphine affects
gestational and offspring neurobehavioral outcomes in mice..
NeuroToxicology. 2023; 99: 292-304 DOI:10.1016/j.neuro.2023.11.008.
Merck Provides U.S. Regulatory Update on Gefapixant - Merck.com. 2023
Xie L, Qin J, Wang T, Zhang S, Luo M, Cheng X, Cao X, Wang H, Yao B,
Xu D, Peng B. Impact of Prenatal Acetaminophen Exposure for Hippocampal
Development Disorder on Mice.. Molecular Neurobiology. 2023; 60(12):
6916-6930. https://link.springer.com/article/10.1007/s12035-023-035154
Dai Y, et al. Prenatal amoxicillin exposure induces developmental toxicity in
fetal mice and its characteristics. J Environ Sci (China) ; 137.0: 287-301.
Montastruc, J.-L. (Emeritus Professor of Medical and Clinical Pharmacology,
Toulouse, France). Drugs and bruxism: A study in the World Health
Organization's pharmacovigilance database. Brit. J. Clin. Pharmacol. 2023;
89(12): 3765-3768-.
Berg, S. et al. (Cook County Health, IL., USA). Acetaminophen overdose
treated in the emergency department: Analysis of Nationwide Emergency
Department Sample (NEDS). Ann. Emerg. Med.. 2023; 82(4,Suppl.): S20-.
Pattnaik, H. et al.. Pneumonia incidence and mortality in clopidogrel
compared to other antiplatelet drugs: A systematic review and meta-analysis.
Chest. 2023; 164(4,Suppl.): 882A-.
Lisa Szatkowski, Don Sharkey, Helen Budge, Shalini Ojha. Association
between opioid use during mechanical ventilation in preterm infants and
evidence of brain injury: a propensity score-matched cohort study.
eClinicalMedicine. 2023;65:102296
Procter TD, et al. Thrombosis with thrombocytopenia syndrome (TTS)
コロナウイルス（ＳＡＲＳ－ＣｏＶ－２）ワクチン（遺伝子組換え
following adenovirus vector COVID-19 vaccination in Canada. Vaccine 2023;
サルアデノウイルスベクター）
41(46): 6802-6809.
Montastruc, J.-L.Drugs and bruxism: A study in the World Health
108 リスペリドン
Organization's pharmacovigilance database.Brit. J. Clin. Pharmacol.
2023;89(12):3765-3768.
Rahman, A. et al. Gabapentinoids and the risk of severe exacerbations in
109 プレガバリン
patients with chronic obstructive pulmonary disease. Europ. Resp. J.
2023;62(Suppl.67):OA884.
Smith CL, Kasza J, Woods RL, Lockery JE, Kirpach B, Reid CM, et al.
Compliance-Adjusted Estimates of Aspirin Effects Among Older Persons in
110 アスピリン・ボノプラザンフマル酸塩配合剤
the ASPREE Randomized Trial. American Journal of Epidemiology.
2023;192(12):2063-2074
Roberti S, Higa R, White V. Critical role of mTOR, PPARγ and PPARδ
111 シロリムス
signaling in regulating early pregnancy decidual function, embryo viability and
feto-placental growth. Molecular Human Reproduction. 2018;24(6):327-340.
大北喜基，他. 潰瘍性大腸炎における術後長期予後：回腸嚢関連感染性合
112 プレドニゾロン
併症に関連する因子の検討. 第７８回日本消化器外科学会総会. 2023: O131.
Klomjit, N. et al. (University of Minnesota, MN., USA). Frequency and
characteristics of chemotherapy-associated thrombotic microangiopathy:
113 ボルテゾミブ
Analysis from a large pharmacovigilance database. Am. J. Hematol.. 2023;
98(12): E369-E372-.
Zimu Chen, Zhi Xu, Chenjie Gao, Lei Chen, Tingting Tan, Wenhao Jiang,
Bingwei Chen, Yonggui Yuan, Zhijun Zhang. Escitalopram-induced QTc
114 エスシタロプラムシュウ酸塩
prolongation and its relationship with KCNQ1, KCNE1, and KCNH2 gene
polymorphisms. Journal of Affective Disorders,2024,347,399-405
Jung-Hyun Kim, Hyesung Lee, Dongyeon Jeong, Ji-Hyang Lee, Hyouk-Soo
Kwon, Woo-Jung Song, You Sook Cho, Ye-Jee Kim, Yong-Wook Shin, TaeBum Kim. The Risk of Neuropsychiatric Adverse Events With Use of
115 モンテルカストナトリウム
Leukotriene Receptor Antagonists in Patients With Asthma: Analysis of
Korea's National Health Insurance Sharing Service Database.. The journal of
allergy and clinical immunology. In practice. 2023;11(12):3690-99.e7
Urooj Javed et al.Short-acting beta-agonists and steroids are associated with
116 デキサメタゾン
the development of aerodigestive disease in particulate matter-exposed
firefighters.Chest.2023;164(4):Suppl.5114A-5115A.
L.Wang, et al. Predictors of fatal and nonfatal overdose after prescription of
opioids for chronic pain: a systematic review and meta-analysis of
117 フェンタニルクエン酸塩
observational studies. Canadian Medical Association Journal
2023;195(41):E1399-E1411
107
6
（2023年12月1日～2024年3月31日）
タクロリムス水和物
97 ボルテゾミブ
ペメトレキセドナトリウム水和物
98 ゾルピデム酒石酸塩
99
モルヒネ塩酸塩水和物
モルヒネ硫酸塩水和物
100 ゲーファピキサントクエン酸塩
101 トラマドール塩酸塩・アセトアミノフェン配合剤
102 アモキシシリン水和物
パロキセチン塩酸塩水和物
メトクロプラミド
103 塩酸メトクロプラミド
オランザピン
リスペリドン
104 アセトアミノフェン
105 クロピドグレル硫酸塩
モルヒネ塩酸塩水和物
アヘン
106 アヘンチンキ
アヘン・トコン
アヘンアルカロイド塩酸塩
Largeau, B. et al. (CHU Tours, Tours, France). Thrombotic microangiopathy
associated with anticancer and immune system targeting drugs: New insights
from real-world data using the WHO pharmacovigilance database. J. Intern.
Med.. 2023; 294(5): 665-678-.
Mekkawy KL, et al. Immediate Postoperative Zolpidem Use Increases Risk of
Falls and Implant Complication Rates Following Total Hip Arthroplasty: A
Retrospective Case-Control Analysis. J Arthroplasty ; 39(1.0): * 169173.e1.
Smith BL, et al.. Perinatal morphine but not buprenorphine affects
gestational and offspring neurobehavioral outcomes in mice..
NeuroToxicology. 2023; 99: 292-304 DOI:10.1016/j.neuro.2023.11.008.
Merck Provides U.S. Regulatory Update on Gefapixant - Merck.com. 2023
Xie L, Qin J, Wang T, Zhang S, Luo M, Cheng X, Cao X, Wang H, Yao B,
Xu D, Peng B. Impact of Prenatal Acetaminophen Exposure for Hippocampal
Development Disorder on Mice.. Molecular Neurobiology. 2023; 60(12):
6916-6930. https://link.springer.com/article/10.1007/s12035-023-035154
Dai Y, et al. Prenatal amoxicillin exposure induces developmental toxicity in
fetal mice and its characteristics. J Environ Sci (China) ; 137.0: 287-301.
Montastruc, J.-L. (Emeritus Professor of Medical and Clinical Pharmacology,
Toulouse, France). Drugs and bruxism: A study in the World Health
Organization's pharmacovigilance database. Brit. J. Clin. Pharmacol. 2023;
89(12): 3765-3768-.
Berg, S. et al. (Cook County Health, IL., USA). Acetaminophen overdose
treated in the emergency department: Analysis of Nationwide Emergency
Department Sample (NEDS). Ann. Emerg. Med.. 2023; 82(4,Suppl.): S20-.
Pattnaik, H. et al.. Pneumonia incidence and mortality in clopidogrel
compared to other antiplatelet drugs: A systematic review and meta-analysis.
Chest. 2023; 164(4,Suppl.): 882A-.
Lisa Szatkowski, Don Sharkey, Helen Budge, Shalini Ojha. Association
between opioid use during mechanical ventilation in preterm infants and
evidence of brain injury: a propensity score-matched cohort study.
eClinicalMedicine. 2023;65:102296
Procter TD, et al. Thrombosis with thrombocytopenia syndrome (TTS)
コロナウイルス（ＳＡＲＳ－ＣｏＶ－２）ワクチン（遺伝子組換え
following adenovirus vector COVID-19 vaccination in Canada. Vaccine 2023;
サルアデノウイルスベクター）
41(46): 6802-6809.
Montastruc, J.-L.Drugs and bruxism: A study in the World Health
108 リスペリドン
Organization's pharmacovigilance database.Brit. J. Clin. Pharmacol.
2023;89(12):3765-3768.
Rahman, A. et al. Gabapentinoids and the risk of severe exacerbations in
109 プレガバリン
patients with chronic obstructive pulmonary disease. Europ. Resp. J.
2023;62(Suppl.67):OA884.
Smith CL, Kasza J, Woods RL, Lockery JE, Kirpach B, Reid CM, et al.
Compliance-Adjusted Estimates of Aspirin Effects Among Older Persons in
110 アスピリン・ボノプラザンフマル酸塩配合剤
the ASPREE Randomized Trial. American Journal of Epidemiology.
2023;192(12):2063-2074
Roberti S, Higa R, White V. Critical role of mTOR, PPARγ and PPARδ
111 シロリムス
signaling in regulating early pregnancy decidual function, embryo viability and
feto-placental growth. Molecular Human Reproduction. 2018;24(6):327-340.
大北喜基，他. 潰瘍性大腸炎における術後長期予後：回腸嚢関連感染性合
112 プレドニゾロン
併症に関連する因子の検討. 第７８回日本消化器外科学会総会. 2023: O131.
Klomjit, N. et al. (University of Minnesota, MN., USA). Frequency and
characteristics of chemotherapy-associated thrombotic microangiopathy:
113 ボルテゾミブ
Analysis from a large pharmacovigilance database. Am. J. Hematol.. 2023;
98(12): E369-E372-.
Zimu Chen, Zhi Xu, Chenjie Gao, Lei Chen, Tingting Tan, Wenhao Jiang,
Bingwei Chen, Yonggui Yuan, Zhijun Zhang. Escitalopram-induced QTc
114 エスシタロプラムシュウ酸塩
prolongation and its relationship with KCNQ1, KCNE1, and KCNH2 gene
polymorphisms. Journal of Affective Disorders,2024,347,399-405
Jung-Hyun Kim, Hyesung Lee, Dongyeon Jeong, Ji-Hyang Lee, Hyouk-Soo
Kwon, Woo-Jung Song, You Sook Cho, Ye-Jee Kim, Yong-Wook Shin, TaeBum Kim. The Risk of Neuropsychiatric Adverse Events With Use of
115 モンテルカストナトリウム
Leukotriene Receptor Antagonists in Patients With Asthma: Analysis of
Korea's National Health Insurance Sharing Service Database.. The journal of
allergy and clinical immunology. In practice. 2023;11(12):3690-99.e7
Urooj Javed et al.Short-acting beta-agonists and steroids are associated with
116 デキサメタゾン
the development of aerodigestive disease in particulate matter-exposed
firefighters.Chest.2023;164(4):Suppl.5114A-5115A.
L.Wang, et al. Predictors of fatal and nonfatal overdose after prescription of
opioids for chronic pain: a systematic review and meta-analysis of
117 フェンタニルクエン酸塩
observational studies. Canadian Medical Association Journal
2023;195(41):E1399-E1411
107
6