Post-market drug safety evidence sources: an analysis of FDA drug safety communications

被引：27

作者：

Ishiguro, Chieko ^{[1
]}

Hall, Marni ^{[2
]}

Neyarapally, George A. ^{[2
]}

Dal Pan, Gerald ^{[2
]}

机构：

[1] Pharmaceut & Med Devices Agcy, Off Safety 1, Div Surveillance & Anal, Tokyo, Japan

[2] US FDA, Off Surveillance & Epidemiol, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA

来源：

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY | 2012年 / 21卷 / 10期

关键词：

APROTININ; RISK; ROSIGLITAZONE; DEATH;

D O I：

10.1002/pds.3317

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

引用

页码：1134 / 1136

页数：3

共 17 条

[1]

[Anonymous], 2011, FDA DRUG SAF COMM SA, V11, P1

[2] Developing the Sentinel System - A National Resource for Evidence Development [J].

Behrman, Rachel E. ;

Benner, Joshua S. ;

Brown, Jeffrey S. ;

McClellan, Mark ;

Woodcock, Janet ;

Platt, Richard .

NEW ENGLAND JOURNAL OF MEDICINE, 2011, 364 (06) :498-499

[3] ADHD Drugs and Serious Cardiovascular Events in Children and Young Adults [J].

Cooper, William O. ;

Habel, Laurel A. ;

Sox, Colin M. ;

Chan, K. Arnold ;

Arbogast, Patrick G. ;

Cheetham, T. Craig ;

Murray, Katherine T. ;

Quinn, Virginia P. ;

Stein, C. Michael ;

Callahan, S. Todd ;

Fireman, Bruce H. ;

Fish, Frank A. ;

Kirshner, Howard S. ;

O'Duffy, Anne ;

Connell, Frederick A. ;

Ray, Wayne A. .

NEW ENGLAND JOURNAL OF MEDICINE, 2011, 365 (20) :1896-1904

[4]

Drug Safety Information for Healthcare Professionals, 2010, DRUG SAF INF HEALTHC

[5]

FDA, 2008, SENT IN NAT STRAT MO

[6]

FDA, 2010, FDA DRUG SAF COMM ER

[7]

FDA significantly restricts access to the diabetes drug Avandia, 2010, FDA SIGN RESTR ACC D

[8]

Food And Drugs Administration (FDA), 2007, FDA DIR ADHD DRUG MA

[9] Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated With Rosiglitazone or Pioglitazone [J].

Graham, David J. ;

Ouellet-Hellstrom, Rita ;

MaCurdy, Thomas E. ;

Ali, Farzana ;

Sholley, Christopher ;

Worrall, Christopher ;

Kelman, Jeffrey A. .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2010, 304 (04) :411-418

[10] Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy:: randomised, double-blind, placebo-controlled trial [J].

Henke, M ;

Laszig, R ;

Rübe, C ;

Schäfer, U ;

Haase, KD ;

Schilcher, B ;

Mose, S ;

Beer, KGT ;

Burger, U ;

Dougherty, C ;

Frommhold, H .

LANCET, 2003, 362 (9392) :1255-1260

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