Research Article| Volume 20, SUPPLEMENT 3, C40-C44, 1998

Limitations and strengths of spontaneous reports data

  • Stephen A. Goldman
    Address correspondence to: Stephen A. Goldman, MD, Associate Director for Medicine, MedWatch, Office of the Commissioner, US Food and Drug Administration, 5600 Fishers Lane, HF-2, Room 17-65, Rockville, MD 20857.
    US Food and Drug Administration, Rockville, Maryland U.S.A.
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      US Food and Drug Administration (FDA) monitoring of the continued safety of marketed medical products depends greatly on spontaneous reporting of serious adverse events by health professionals. Despite its inherent limitations, the national postmarketing surveillance system provides vital information of clinical importance.


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        • Koch-Weser J
        • Sellers EM
        • Zacest R
        The ambiguity of adverse drug reactions.
        Eur J Clin Pharmacol. 1977; 11: 75-78
        • Green DM
        Pre-existing conditions, placebo reactions, and “side effects”.
        Ann Intern Med. 1964; 60: 255-265
        • Reidenberg MM
        • Lowenthal DT
        Adverse nondrug reactions.
        NEJM. 1968; 279: 678-679
        • Karch FE
        • Smith CL
        • Kerzner B
        • et al.
        Adverse drug reactions—a matter of opinion.
        Clin Pharmacol Ther. 1976; 19: 489-492
        • Chen RT
        • Rastogi SC
        • Mullen JR
        • et al.
        The Vaccine Adverse Event Reporting System (VAERS).
        Vaccine. 1994; 12: 542-550
        • Rawlins MD
        Pharmacovigilance: Paradise lost, regained or postponed? The William Withering Lecture 1994.
        J R Coll Physicians Lond. 1995; 29: 41-49
        • Strom BL
        • Tugwell P
        Pharmacoepidemiology: Current status, prospects, and problems.
        Ann Intern Med. 1990; 113: 179-181
        • Scott HD
        • Rosenbaum SE
        • Waters WJ
        • et al.
        Rhode Island physicians' recognition and reporting of adverse drug reactions.
        R I Med J. 1987; 70: 311-316
        • Sachs RM
        • Bortnichak EA
        An evaluation of spontaneous adverse drug reaction monitoring systems.
        Am J Med. 1986; 81 (Suppl 5B): 49-55
        • Weber JCP
        Epidemiology of adverse reactions to nonsteroidal antiinflammatory drugs.
        in: Rainsford KD Velo GP Advances in Inflammation Research. 6. Raven Press, New York1984: 1-7
        • Begaud B
        • Moride Y
        • Tubert-Bitter P
        • et al.
        False-positives in spontaneous reporting: Should we worry about them?.
        Br J Clin Pharmacol. 1994; 38: 401-404
        • Serradell J
        • Bjornson DC
        • Hartzema AG
        Drug utilization study methodologies: National and international perspectives.
        Drug Intell Clin Pharm. 1987; 21: 994-1001
        • Fletcher AP
        Spontaneous adverse drug reaction reporting vs event monitoring: A comparison.
        J R Soc Med. 1991; 84: 341-344
        • Finney DJ
        The detection of adverse reactions to therapeutic drugs.
        Stat Med. 1982; 1: 153-161
        • Finney DJ
        Statistical aspects of monitoring for dangers in drug therapy.
        Methods Inf Med. 1971; 10: 1-8
      1. Standardization of definitions and criteria of causality assessment of adverse drug reactions: Drug-induced liver disorders: Report of an international consensus meeting.
        Int J Clin Pharmacol Ther Toxicol. 1990; 28: 317-322
        • Auriche M
        • Loupi E
        Does proof of causality ever exist in pharmacovigilance?.
        Drug Saf. 1993; 9: 230-235
        • Temple RJ
        • Jones JK
        • Crout JR
        Adverse effects of newly marketed drugs.
        NEJM. 1979; 300: 1046-1047
        • Rossi AC
        • Knapp DE
        Discovery of new adverse drug reactions: A review of the Food and Drug Administration's Spontaneous Reporting System.
        JAMA. 1984; 252: 1030-1033