Regulatory action on rosiglitazone by the U.S. Food and Drug Administration

New England Journal of Medicine

Volumn 363, Issue 16, 2010, Pages 1489-1491

  Woodcock, Janet ^a   Sharfstein, Joshua M ^b   Hamburg, Margaret ^b  

^a Center for Drug Evaluation and Research   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLIMEPIRIDE PLUS ROSIGLITAZONE; METFORMIN; METFORMIN PLUS ROSIGLITAZONE; PIOGLITAZONE; PLACEBO; ROSIGLITAZONE; SULFONYLUREA DERIVATIVE; 2,4 THIAZOLIDINEDIONE DERIVATIVE;

CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CLINICAL DECISION MAKING; CLINICAL TRIAL; CONSULTATION; DIET; DISEASE SEVERITY; DRUG CONTROL; DRUG LABELING; DRUG MARKETING; DRUG SAFETY; EXERCISE; FOOD AND DRUG ADMINISTRATION; GLYCEMIC CONTROL; HEART INFARCTION; HUMAN; HYPERGLYCEMIA; ISCHEMIC HEART DISEASE; MEDICAL INFORMATION; NON INSULIN DEPENDENT DIABETES MELLITUS; OBSERVATIONAL STUDY; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; SHORT SURVEY; UNITED STATES; CHEMICALLY INDUCED; DIABETES MELLITUS, TYPE 2; MORTALITY;

CARDIOVASCULAR DISEASES; DIABETES MELLITUS, TYPE 2; DRUG AND NARCOTIC CONTROL; HUMANS; MYOCARDIAL INFARCTION; THIAZOLIDINEDIONES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77957952617     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1010788     Document Type: Short Survey

References (5)

1. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007;356:2457-71. [Erratum, N Engl J Med 2007;357:100.]
2. UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998;352:854-65. [Erratum, Lancet 1998;352:1558.]
3. U.S. Food and Drug Administration. FDA drug safety communication: ongoing safety review of Actos (pioglitazone) and potential increased risk of bladder cancer after two years exposure. (http://www.fda.gov/Drugs/ DrugSafety/ ucm226214.htm.)
4. Home PD, Pocock SJ, Beck-Nielsen H, et al. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet 2009; 373:2125-35.
5. U.S. Food and Drug Administration. Guidance for industry diabetes mellitus - evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. (http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/ Guidances/UCM071627.pdf.)