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. 2018 Jul;27(7):789-796.
doi: 10.1002/pds.4446. Epub 2018 May 24.

Characteristics of drugs safety signals that predict safety related product information update

Widya N Insani  1   2 , Alexandra C Pacurariu  2   3 , Aukje K Mantel-Teeuwisse  1 , Liana Gross-Martirosyan  2
Affiliations

Characteristics of drugs safety signals that predict safety related product information update

Widya N Insani et al. Pharmacoepidemiol Drug Saf. 2018 Jul.

Abstract

Purpose: Investigation of drug safety signals is one of the major tasks in pharmacovigilance. Among many potential signals identified, only a few reflect adverse drug reactions requiring regulatory actions, such as product information (PI) update. Limited information is available regarding the signal characteristics that might predict PI update following signal evaluation. The objective of this study was to identify signal characteristics associated with PI updates following signal evaluation by the European Medicines Agency Pharmacovigilance Risk Assessment Committee during 2012 to 2016.

Methods: A comparative study was performed based on data from 172 safety signals. Characteristics of signals were extracted from the European Pharmacovigilance Issues Tracking Tool database. Multivariable logistic regression analysis was used to assess the relationship between signal characteristics and the decision to update the PI.

Results: Multivariable logistic regression analysis showed that the presence of evidence in multiple types of data sources (adjusted odds ratio [OR] 7.8 95% CI [1.5, 40.1]); mechanistic plausibility of the drug-event association (adjusted OR 3.9 95% CI [1.9, 8.0]); seriousness of the event (adjusted OR 4.2 95% CI [1.3, 13.9]); and age of drugs ≤5 years (adjusted OR 3.9 95% CI [1.2, 12.7]) were associated with the decision to change the PI (P < 0.05).

Conclusions: This study identified 4 characteristics of drug safety signals that have shown to be associated with PI changes as outcome of signal evaluation. These characteristics may be used as criteria for selection and prioritization of potential signals that are more likely to necessitate product information updates.

Keywords: drug labeling; pharmacoepidemiology; pharmacovigilance; post-market drug safety; safety signal.

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Figures

Figure 1
Figure 1
Section of product information updated following safety signal evaluation by the PRAC during September 2012 to May 2016
See this image and copyright information in PMC

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