Serious adverse drug reactions in older adults notified to pharmacovigilance

Therapie. 2012 Sep-Oct;67(5):465-70. doi: 10.2515/therapie/2012060. Epub 2012 Dec 18.

Abstract

Purpose: To report the serious adverse drug reactions (ADRs) in older adults notified to pharmacovigilance, to identify the incriminated drugs and to search for risk factors of occurrence.

Methods: A retrospective study including 106 serious adverse drug reactions notified to pharmacovigilance in patients aged of 65 years and more, over a period of 16 years. Imputation was established according to the French method and seriousness according to the World Health Organisation (WHO) criteria.

Results: Adverse drug reactions were essentially systemic. Incriminated drugs were mainly antibiotics, allopurinol and cardio-vascular drugs. Gender, age and number of administered drugs did not seem to be risk factors of serious ADRs occurrence. Among older adults, 4% died further to a serious ADRs.

Conclusion: Systemic notification to pharmacovigilance will allow a better analysis of risk factors of serious ADRs occurrence and to insure safety and health to the older adults.

Publication types

  • Evaluation Study

MeSH terms

  • Adverse Drug Reaction Reporting Systems / statistics & numerical data*
  • Age Factors
  • Aged
  • Aged, 80 and over
  • Disease Notification / statistics & numerical data
  • Drug Interactions
  • Drug-Related Side Effects and Adverse Reactions / diagnosis
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Drug-Related Side Effects and Adverse Reactions / etiology
  • Female
  • Humans
  • Male
  • Pharmacovigilance*
  • Retrospective Studies
  • Risk Factors
  • Severity of Illness Index
  • Tunisia / epidemiology