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Br Med J (Clin Res Ed). 1983 February 5; 286(6363): 458–460.
PMCID: PMC1546762

Identification of adverse reactions to new drugs. III: Alerting processes and early warning systems.

Abstract

The process of discovery for 18 important adverse drug reactions was analysed in terms of study designs and other features which determined whether published reports of suspected adverse reactions were convincing or provided valid evidence of causality. First alerts were almost always anecdotal reports. For earlier alerting during clinical trials event recording is needed, associated with dose-response data and the use of patients as their own controls.

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.
  • Venning GR. Identification of adverse reactions to new drugs. I: What have been the important adverse reactions since thalidomide? Br Med J (Clin Res Ed) 1983 Jan 15;286(6360):199–202. [PMC free article] [PubMed]
  • Venning GR. Identification of adverse reactions to new drugs. II--How were 18 important adverse reactions discovered and with what delays? Br Med J (Clin Res Ed) 1983 Jan 22;286(6361):289–292. [PMC free article] [PubMed]
  • Venning GR. Identification of adverse reactions to new drugs. II (continued): How were 18 important adverse reactions discovered and with what delays? Br Med J (Clin Res Ed) 1983 Jan 29;286(6362):365–368. [PMC free article] [PubMed]
  • Skegg DC, Doll R. Record linkage for drug monitoring. J Epidemiol Community Health. 1981 Mar;35(1):25–31. [PMC free article] [PubMed]
  • Venning GR. Validity of anecdotal reports of suspected adverse drug reactions: the problem of false alarms. Br Med J (Clin Res Ed) 1982 Jan 23;284(6311):249–252. [PMC free article] [PubMed]

Articles from British Medical Journal (Clinical Research Ed.) are provided here courtesy of BMJ Publishing Group