Causality assessment and examples of adverse drug reactions (drug-induced liver injury, renal, skin, and major adverse cardiac events)

Charles Schubert, Monali Desai, Meenal Patwardhan, Fabio Lievano, Syed S. Islam, Deepa H. Chand, Hans Peter Bacher, Suzanne Pauline Green, Arsalan Shabbir, Jawed Fareed, Verghese Mathew

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

An adverse drug reaction is a side effect for which the cause can be directly attributed to a drug and its physiologic properties. The ability to discern if a side effect is truly caused by a specific drug or is confounded by the patient’s concurrent medical condition(s) and/or concomitant medications is an art based on the totality of the available evidence combined with a systematic approach. In addition to an introduction to the methodology for evaluating causality, this chapter focuses on the evaluation of side effects seen in commonly affected organs/organ systems (the liver, kidney, skin, and cardiovascular system) and highlights the factors that may need to be considered within these areas to determine a causal relationship. Examples of common drug-induced reactions in these organ systems are also provided to demonstrate the process of assessing such reactions.

Original languageEnglish
Title of host publicationPharmacovigilance
Subtitle of host publicationA Practical Approach
PublisherElsevier
Pages47-67
Number of pages21
ISBN (Electronic)9780323581165
ISBN (Print)9780323581172
DOIs
StatePublished - Jan 1 2018
Externally publishedYes

Keywords

  • Adverse drug reaction
  • Adverse event
  • Causality
  • Drug association
  • Side effect

Fingerprint Dive into the research topics of 'Causality assessment and examples of adverse drug reactions (drug-induced liver injury, renal, skin, and major adverse cardiac events)'. Together they form a unique fingerprint.

  • Cite this

    Schubert, C., Desai, M., Patwardhan, M., Lievano, F., Islam, S. S., Chand, D. H., Bacher, H. P., Green, S. P., Shabbir, A., Fareed, J., & Mathew, V. (2018). Causality assessment and examples of adverse drug reactions (drug-induced liver injury, renal, skin, and major adverse cardiac events). In Pharmacovigilance: A Practical Approach (pp. 47-67). Elsevier. https://doi.org/10.1016/B978-0-323-58116-5.00004-3