Safety in numbers - Monitoring risk in approved drugs

New England Journal of Medicine

Volumn 352, Issue 12, 2005, Pages 1173-1176

  Okie, Susan ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOOXYGENASE 2 INHIBITOR; ROFECOXIB;

ARTHRITIS; DRUG APPROVAL; DRUG EFFICACY; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL HEMORRHAGE; HEART INFARCTION; HUMAN; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DRUG APPROVAL; HEALTH POLICY; HUMANS; PHARMACEUTICAL PREPARATIONS; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 15444380375     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJMp058029     Document Type: Review

References (4)

1. FDA drug review, postapproval risks, 1976-85. Washington, D.C.: General Accounting Office, April 1990. (GAO/PEMD-90-15.)
2. Dai C, Stafford RS, Alexander GC. National trends in cyclooxygenase-2 inhibitor use since market release: nonselective diffusion of a selectively cost-effective innovation. Arch Intern Med 2005;165:158-60.
3. Psaty BM, Furberg CD, Ray WA, Weiss NS. Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis. JAMA 2004; 292:2622-31.
4. Harris G. F.D.A. moves toward more openness with the public. New York Times. February 20, 2005:A28.