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資料２－４ 研究報告の報告状況 (13 ページ)
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| 出典情報 | 薬事・食品衛生審議会 薬事分科会医薬品等安全対策部会（令和3年度 第3回 3／11）《厚生労働省》 |
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研究報告の報告状況
(2021年8月1日～2021年11月30日)
NO 一般名
309 クロピドグレル硫酸塩
310 クロピドグレル硫酸塩
ドンペリドン
311 メトクロプラミド
塩酸メトクロプラミド
クエチアピンフマル酸塩
312 オランザピン
アリピプラゾール
文献名
Kaur, A. et al. (McGill University Health Centre, Quebec, Canada). Role of genetics in sex-specific
effects of clopidogrel on atherothrombotic events. J. Am. Coll. Cardiol.. 2021; 77(18,Suppl.1): 181-.
Patel, M. et al. (University of Toledo, OH., USA). Single antiplatelet versus dual antiplatelet therapy in
patients after transcatheter aortic valve replacement: A systematic review and meta-analysis. J. Am.
Coll. Cardiol.. 2021; 77(18,Suppl.1): 942-.
Ou, L.B. et al. (Sunnybrook Health Sciences Centre, Ontario, Canada). Domperidone and the risks of
sudden cardiac death and ventricular arrhythmia: A systematic review and meta-analysis of observational
studies. Brit. J. Clin. Pharmacol.. 2021; 87(10): 3649-3658-.
Gouverneur, A. et al. (Universitaire de Bordeaux, Bordeaux, France). A safety signal of somnambulism
with the use of antipsychotics and lithium: A pharmacovigilance disproportionality analysis. Brit. J. Clin.
Pharmacol.. 2021; 87(10): 3971-3977-.
サルメテロールキシナホ酸塩
サルメテロールキシナホ酸塩・フ
ルチカゾンプロピオン酸エステル
サルブタモール硫酸塩
ビランテロールトリフェニル酢酸 CLINICAL STUDY Inhaled Beta2－Agonists Increase In－Hospital Mortality in ICU Patients
313 塩・フルチカゾンフランカルボン with Heart Failure A Real－World Propensity Score－Matched Study. International Heart
酸エステル
Journal. 2021;62:1076-1082
フルチカゾンフランカルボン酸エ
ステル・ウメクリジニウム臭化物・
ビランテロールトリフェニル酢酸
塩
Ellfolk, M. et al. Second-generation antipsychotic use during pregnancy and risk of congenital
malformations. Europ. J. Clin. Pharmacol. 2021;77(11),1737-1745.
Tsakiridis T, et al. Metformin in Combination With Chemoradiotherapy in Locally Advanced Non-Small
アログリプチン安息香酸塩・メトホ
315
Cell Lung Cancer: The OCOG-ALMERA Randomized Clinical Trial. JAMA Oncology. 2021;7(9):1333ルミン塩酸塩配合剤
1341
Ellfolk, M. et al..Second-generation antipsychotic use during pregnancy and risk of congenital
316 オランザピン
malformations.Europ. J. Clin. Pharmacol. 2021;77(11):1737-1745.
Liang D, et al.. The relationship between valproate versus lamotrigine/levetiracetam use and prognosis in
317 バルプロ酸ナトリウム
patients with epilepsy and heart failure: A Danish register-based study. Pharmacoepidemiology and Drug
Safety (37th International Conference on Pharm、以下略. 2021;30(SUPPL 1):77-78
Effect of adalimumab interventions on general infection among adults: a systematic review and meta318 アダリムマブ（遺伝子組換え）
analysis of randomized controlled trialsExpert Review of Anti-Infective Therapy (United Kingdom),
Volume:19,Issue:10, 1281-1297 : 2021
Association between maternal ritodrine hydrochloride administration during pregnancy and childhood
319 リトドリン塩酸塩
wheezing up to three years of age: The Japan environment and children's study. Pediatric allergy and
immunology : official publication of the European Society of Pediatric Al
アセトアミノフェン
Bauer, Ann Z.Paracetamol use during pregnancy - a call for precautionary action.Nature reviews.
320 トラマドール塩酸塩・アセトアミノ
Endocrinology 2021
フェン配合剤
トラマドール塩酸塩・アセトアミノ Hassaan, S.H..Effects of extended abstinence on cognitive functions in tramadol-dependent patients: A
321
フェン配合剤
cohort study.Neuropsychopharmacology Reports 2021;41(3):371-378.
Fontana RJ，Li YJ，Phillips E，Saeed N，Barnhart H，Kleiner D，Hoofnagle J. Allopurinol hepatotoxicity is
322 アロプリノール
associated with human leukocyte antigen Class I alleles.. Liver International. 2021;41:1884-1893
Schneider, R. et al. Risk of skin cancer in new users of thiazides and thiazide-like diuretics: a cohort
323 インダパミド
study using an active comparator group. Brit. J. Dermatol. 2021;185(2):343-352.
Kaur, A. et al., Role of genetics in sex-specific effects of clopidogrel on atherothrombotic events, J. Am.
324 クロピドグレル硫酸塩
Coll. Cardiol. 77(18),Suppl.1,181,2021
Topical Minoxidil Exposures and Toxicoses in Dogs and Cats: 211 Cases (2001?2019).J AmAnim Hosp
325 ミノキシジル含有一般用医薬品
Assoc 2021;57:225?231
Boncyk, C.S. et al.. Pharmacologic management of intensive care unit delirium: clinical prescribing
326 オランザピン
practices and outcomes in more than 8500 patient encounters. Anesth. Analg.. 2021; 133(3): 713-722.
バルプロ酸ナトリウム
カルバマゼピン
Malformation risk of new anti-epileptic drugs in women with epilepsy; observational data from the Kerala
327
フェノバルビタール
registry of epilepsy and pregnancy (KREP)
フェニトイン
Gross M, Poets C. Lipid enemas for meconium evacuation in preterm infants - a retrospective cohort
328 インドメタシンナトリウム水和物
study. BMC pediatrics. 2021 OCT 18;21(1):454.
Budani, M.. Maternal use of fluconazole and congenital malformations in the progeny: A meta-analysis of
329 フルコナゾール
the literature. Reproductive toxicology. 2021;100:42-51
Cardwell CR，McDowell RD，Hughes CM，Hicks B，Murchie P. Exposure to Ranitidine and Risk of
330 ラニチジン塩酸塩
Bladder Cancer: A Nested Case-Control Study.. The American journal of gastroenterology.
2021;116:1612-1619
Hayato Akimoto，Takuya Nagashima，Takashi Hayakawa，Satoshi Asai，Kimino Minagawa，Yasuo
Takahashi. Regular Article Signal Detection of Potential Hepatotoxic Drugs：Case－Control Study
331 Ｌ－カルボシステイン
Using Both a Spontaneous Reporting System and Electronic Medical Records. Biological ＆
Pharmaceutical Bulletin. 2021; 44(10): 1514-1523.
Charles-Schoeman, C.. The Risk of Venous Thromboembolic Events in Patients with RA Aged >= 50
332 トファシチニブクエン酸塩
Years with >= 1 Cardiovascular Risk Factor: Results from a Phase 3b/4 Randomized Safety Study of
Tofacitinib vs TNF Inhibitors. ACR Convergence 2021. 2021
バルサルタン
Cohen Sedgh, R.. Neoplasm Reports in Food and Drug Administration Adverse Event Reporting System
333 バルサルタン・アムロジピンベシ Following Angiotensin Receptor Blocker Recalls. Circulation. Cardiovascular quality and outcomes.
ル酸塩配合剤
2021;14(8):e007476
314 オランザピン
13
(2021年8月1日～2021年11月30日)
NO 一般名
309 クロピドグレル硫酸塩
310 クロピドグレル硫酸塩
ドンペリドン
311 メトクロプラミド
塩酸メトクロプラミド
クエチアピンフマル酸塩
312 オランザピン
アリピプラゾール
文献名
Kaur, A. et al. (McGill University Health Centre, Quebec, Canada). Role of genetics in sex-specific
effects of clopidogrel on atherothrombotic events. J. Am. Coll. Cardiol.. 2021; 77(18,Suppl.1): 181-.
Patel, M. et al. (University of Toledo, OH., USA). Single antiplatelet versus dual antiplatelet therapy in
patients after transcatheter aortic valve replacement: A systematic review and meta-analysis. J. Am.
Coll. Cardiol.. 2021; 77(18,Suppl.1): 942-.
Ou, L.B. et al. (Sunnybrook Health Sciences Centre, Ontario, Canada). Domperidone and the risks of
sudden cardiac death and ventricular arrhythmia: A systematic review and meta-analysis of observational
studies. Brit. J. Clin. Pharmacol.. 2021; 87(10): 3649-3658-.
Gouverneur, A. et al. (Universitaire de Bordeaux, Bordeaux, France). A safety signal of somnambulism
with the use of antipsychotics and lithium: A pharmacovigilance disproportionality analysis. Brit. J. Clin.
Pharmacol.. 2021; 87(10): 3971-3977-.
サルメテロールキシナホ酸塩
サルメテロールキシナホ酸塩・フ
ルチカゾンプロピオン酸エステル
サルブタモール硫酸塩
ビランテロールトリフェニル酢酸 CLINICAL STUDY Inhaled Beta2－Agonists Increase In－Hospital Mortality in ICU Patients
313 塩・フルチカゾンフランカルボン with Heart Failure A Real－World Propensity Score－Matched Study. International Heart
酸エステル
Journal. 2021;62:1076-1082
フルチカゾンフランカルボン酸エ
ステル・ウメクリジニウム臭化物・
ビランテロールトリフェニル酢酸
塩
Ellfolk, M. et al. Second-generation antipsychotic use during pregnancy and risk of congenital
malformations. Europ. J. Clin. Pharmacol. 2021;77(11),1737-1745.
Tsakiridis T, et al. Metformin in Combination With Chemoradiotherapy in Locally Advanced Non-Small
アログリプチン安息香酸塩・メトホ
315
Cell Lung Cancer: The OCOG-ALMERA Randomized Clinical Trial. JAMA Oncology. 2021;7(9):1333ルミン塩酸塩配合剤
1341
Ellfolk, M. et al..Second-generation antipsychotic use during pregnancy and risk of congenital
316 オランザピン
malformations.Europ. J. Clin. Pharmacol. 2021;77(11):1737-1745.
Liang D, et al.. The relationship between valproate versus lamotrigine/levetiracetam use and prognosis in
317 バルプロ酸ナトリウム
patients with epilepsy and heart failure: A Danish register-based study. Pharmacoepidemiology and Drug
Safety (37th International Conference on Pharm、以下略. 2021;30(SUPPL 1):77-78
Effect of adalimumab interventions on general infection among adults: a systematic review and meta318 アダリムマブ（遺伝子組換え）
analysis of randomized controlled trialsExpert Review of Anti-Infective Therapy (United Kingdom),
Volume:19,Issue:10, 1281-1297 : 2021
Association between maternal ritodrine hydrochloride administration during pregnancy and childhood
319 リトドリン塩酸塩
wheezing up to three years of age: The Japan environment and children's study. Pediatric allergy and
immunology : official publication of the European Society of Pediatric Al
アセトアミノフェン
Bauer, Ann Z.Paracetamol use during pregnancy - a call for precautionary action.Nature reviews.
320 トラマドール塩酸塩・アセトアミノ
Endocrinology 2021
フェン配合剤
トラマドール塩酸塩・アセトアミノ Hassaan, S.H..Effects of extended abstinence on cognitive functions in tramadol-dependent patients: A
321
フェン配合剤
cohort study.Neuropsychopharmacology Reports 2021;41(3):371-378.
Fontana RJ，Li YJ，Phillips E，Saeed N，Barnhart H，Kleiner D，Hoofnagle J. Allopurinol hepatotoxicity is
322 アロプリノール
associated with human leukocyte antigen Class I alleles.. Liver International. 2021;41:1884-1893
Schneider, R. et al. Risk of skin cancer in new users of thiazides and thiazide-like diuretics: a cohort
323 インダパミド
study using an active comparator group. Brit. J. Dermatol. 2021;185(2):343-352.
Kaur, A. et al., Role of genetics in sex-specific effects of clopidogrel on atherothrombotic events, J. Am.
324 クロピドグレル硫酸塩
Coll. Cardiol. 77(18),Suppl.1,181,2021
Topical Minoxidil Exposures and Toxicoses in Dogs and Cats: 211 Cases (2001?2019).J AmAnim Hosp
325 ミノキシジル含有一般用医薬品
Assoc 2021;57:225?231
Boncyk, C.S. et al.. Pharmacologic management of intensive care unit delirium: clinical prescribing
326 オランザピン
practices and outcomes in more than 8500 patient encounters. Anesth. Analg.. 2021; 133(3): 713-722.
バルプロ酸ナトリウム
カルバマゼピン
Malformation risk of new anti-epileptic drugs in women with epilepsy; observational data from the Kerala
327
フェノバルビタール
registry of epilepsy and pregnancy (KREP)
フェニトイン
Gross M, Poets C. Lipid enemas for meconium evacuation in preterm infants - a retrospective cohort
328 インドメタシンナトリウム水和物
study. BMC pediatrics. 2021 OCT 18;21(1):454.
Budani, M.. Maternal use of fluconazole and congenital malformations in the progeny: A meta-analysis of
329 フルコナゾール
the literature. Reproductive toxicology. 2021;100:42-51
Cardwell CR，McDowell RD，Hughes CM，Hicks B，Murchie P. Exposure to Ranitidine and Risk of
330 ラニチジン塩酸塩
Bladder Cancer: A Nested Case-Control Study.. The American journal of gastroenterology.
2021;116:1612-1619
Hayato Akimoto，Takuya Nagashima，Takashi Hayakawa，Satoshi Asai，Kimino Minagawa，Yasuo
Takahashi. Regular Article Signal Detection of Potential Hepatotoxic Drugs：Case－Control Study
331 Ｌ－カルボシステイン
Using Both a Spontaneous Reporting System and Electronic Medical Records. Biological ＆
Pharmaceutical Bulletin. 2021; 44(10): 1514-1523.
Charles-Schoeman, C.. The Risk of Venous Thromboembolic Events in Patients with RA Aged >= 50
332 トファシチニブクエン酸塩
Years with >= 1 Cardiovascular Risk Factor: Results from a Phase 3b/4 Randomized Safety Study of
Tofacitinib vs TNF Inhibitors. ACR Convergence 2021. 2021
バルサルタン
Cohen Sedgh, R.. Neoplasm Reports in Food and Drug Administration Adverse Event Reporting System
333 バルサルタン・アムロジピンベシ Following Angiotensin Receptor Blocker Recalls. Circulation. Cardiovascular quality and outcomes.
ル酸塩配合剤
2021;14(8):e007476
314 オランザピン
13