Value of epidemiologic studies in determining the true incidence of adverse events: The nonsteroidal anti-inflammatory drug story

Archives of Internal Medicine

Volumn 157, Issue 18, 1997, Pages 2129-2136

  Miwa, Linda J ^a   Jones, Judith K ^a   Pathiyal, Atul ^a   Hatoum, Hind ^b  

^a The Degge Group Ltd   (United States)

^b PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DICLOFENAC; NABUMETONE; NAPROXEN; NONSTEROID ANTIINFLAMMATORY AGENT; PIROXICAM;

ANALGESIA; ANTIINFLAMMATORY ACTIVITY; ARTICLE; COMPUTER PROGRAM; DATA ANALYSIS; DISEASE ASSOCIATION; DUODENUM BLEEDING; EPIDEMIOLOGICAL DATA; FOOD AND DRUG ADMINISTRATION; HUMAN; INCIDENCE; INFLAMMATION; META ANALYSIS; PRIORITY JOURNAL; QUANTITATIVE DIAGNOSIS; RELIABILITY; RISK FACTOR; STOMACH HEMORRHAGE;

EID: 0030923555     PISSN: 00039926     EISSN: None     Source Type: Journal    
DOI: 10.1001/archinte.157.18.2129     Document Type: Article

References (11)

1. Gabriel SE, Jaakkimainen L, Bombardier C. Risk for serious gastrointestinal complications related to use of nonsteroidal anti-inflammatory drugs: a metaanalysis. Ann Intern Med. 1991;115:787-796.
2. Rabinovitz M, Van Thiel DH. Hepatotoxicity of nonsteroidal anti-inflammatory drugs. Am J Gastroenterol. 1992;87:1696-1704.
3. Roujeau JC, Kelly JP, Naldi L, et al. Medication use and the risk of Stevens-Johnson syndrome or toxic epidermal necrolysis. N Engl J Med. 1995;333:1600-1607.
4. Sachs RM, Dieck GS. The feldene experience: a case study. In: Horisberger B, Dinkel R, eds. The Perception and Management of Drug Safety Risks. New York, NY: Springer-Verlag NY Inc; 1989:81-89.
5. Banks AT, Zimmerman HJ, Ishak KG, Harter JG. Diclofenac-associated hepatotoxicity. Hepatology. 1995;22:820-827.
6. Jones JK. Regulatory use of adverse drug reactions. In: Skandia International Symposia on Detection and Prevention of Adverse Drug Reactions. Stockholm, Sweden: Almqvist & Wiksell International; 1984:203-214.
7. Meinzinger MM, Barry WS. Prospective study of the influence of the media on reporting medical events. Drug Inform J. 1990;24:575-577.
8. Stang PE, Fox JL. Adverse events and the Freedom of Information Act: an apple in Eden. Ann Pharmacother. 1992;26:238-243.
9. Department of Health and Human Services, Public Health Service, Food and Drug Administration. 'COSTART' Coding Symbols for Thesaurus of Adverse Reaction Terms. Springfield, Va: National Technical Information Service; 1994.
10. Adverse experience reporting requirements for human drug and licensed biological products: proposed rule (21 CFR) Docket 93N-0181, parts 20, 310, 312, 314, and 600. Federal Register. 1994;59:54046-54064.
11. Baum C, Kweder SL, Anello C. The spontaneous reporting system in the United States. In: Strom BL, ed. Pharmacoepidemiology. 2nd ed. New York, NY: John Wiley & Sons Inc; 1994:125-137.