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
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
收藏
页码:1134 / 1136
页数:3
相关论文
共 17 条
[11]   Maintaining normal hemoglobin levels with epoetin alfa in mainly nonanemic patients with metastatic breast cancer receiving first-line chemotherapy: A survival study [J].
Leyland-Jones, B ;
Semiglazov, V ;
Pawlicki, M ;
Pienkowski, T ;
Tjulandin, S ;
Manikhas, G ;
Makhson, A ;
Roth, A ;
Dodwell, D ;
Baselga, J ;
Biakhov, M ;
Valuckas, K ;
Voznyi, E ;
Liu, XY ;
Vercammen, E .
JOURNAL OF CLINICAL ONCOLOGY, 2005, 23 (25) :5960-5972
[12]   The risk associated with aprotinin in cardiac surgery [J].
Mangano, DT ;
Tudor, IC ;
Dietzel, C .
NEW ENGLAND JOURNAL OF MEDICINE, 2006, 354 (04) :353-365
[13]   Potential Safety Signals and Their Significance [J].
Powers, Abbey ;
Cook, G. Elliott .
ARCHIVES OF INTERNAL MEDICINE, 2012, 172 (01) :72-73
[14]   Aprotinin during coronary-artery bypass grafting and risk of death [J].
Schneeweiss, Sebastian ;
Seeger, John D. ;
Landon, Joan ;
Walker, Alexander M. .
NEW ENGLAND JOURNAL OF MEDICINE, 2008, 358 (08) :771-783
[15]   The effect of aprotinin on outcome after coronary-artery bypass grafting. [J].
Shaw, Andrew D. ;
Stafford-Smith, Mark ;
White, William D. ;
Phillips-Bute, Barbara ;
Swaminathan, Madhav ;
Milano, Carmelo ;
Welsby, Ian J. ;
Aronson, Solomon ;
Mathew, Joseph P. ;
Peterson, Eric D. ;
Newman, Mark F. .
NEW ENGLAND JOURNAL OF MEDICINE, 2008, 358 (08) :784-793
[16]   Role of Postmarketing Surveillance in Contemporary Medicine [J].
Woodcock, Janet ;
Behrman, Rachel E. ;
Dal Pan, Gerald J. .
ANNUAL REVIEW OF MEDICINE, VOL 62, 2011, 2011, 62 :1-10
[17]   Regulatory Action on Rosiglitazone by the US Food and Drug Administration [J].
Woodcock, Janet ;
Sharfstein, Joshua M. ;
Hamburg, Margaret .
NEW ENGLAND JOURNAL OF MEDICINE, 2010, 363 (16) :1489-1491