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The Unintended Consequences of Adverse Event Information on Medicines’ Risks and Label Content

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Abstract

Patients and prescribers need to be aware of adverse drug events to minimize the risk of their occurrence and the severity with which they appear. However, numerous studies show that being informed about adverse events can increase the possibility of suffering from them. Patients tend to overestimate the likelihood of experiencing the adverse events included in the label, and this can contribute to worsening the negative expectations which are at the root of the nocebo effect. In fact, patients can become anxious after reading the undesirable effects section of the leaflet and, in addition to suffering from the nocebo effect, might not take a drug they could benefit from due to the fear of experiencing adverse events. In addition, patients’ attention can focus towards non-specific symptoms of daily living that can be misattributed to the drug and included in the labelling. This article proposes a number of suggestions to reduce the abovementioned unintended effects associated with labelling, namely, an increased focus on the excess risk of experiencing adverse events rather than crude incidence, using attribute framing to help patients to better understand the risk of experiencing adverse events, dividing the undesirable effect section of the leaflet into subsections according to the level of evidence supporting causal relationships and, finally, restricting the addition of non-specific adverse events that are also symptoms of daily living to only those where there is enough evidence to show they have been caused by the drug. More studies on how to minimize the nocebo effect induced by adverse event information should be performed, and these should be done in collaboration with health authorities, to reach a shared consensus on how to better present adverse event information in the label.

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Fig. 1

Being informed about drug AEs can cause fear of experiencing them and mistrust. This can trigger increased reporting of AEs due to the nocebo effect, misattribution of ailments of daily life to the drug and decrease in drug intake compliance (a source of untoward medical conditions). These additional AEs can be included in the label, thus causing even more fear and mistrust

Fig. 2

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Authors and Affiliations

  1. Pfizer s.r.l, Safety Surveillance and Risk Management, Milan, Italy

    Giovanni Furlan

  2. Helsinn Birex Pharmaceuticals, Global Drug Safety, Dublin, Ireland

    David Power

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  1. Giovanni Furlan
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Correspondence to Giovanni Furlan.

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Giovanni Furlan is an employee of a pharmaceutical company (Pfizer), holds some Pfizer stock options, and has some healthcare exchange trade funds. David Power is an employee of a pharmaceutical company (Helsinn Birex Pharmaceuticals).

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Giovanni Furlan and David Power have contributed to all the sections of the article.

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Furlan, G., Power, D. The Unintended Consequences of Adverse Event Information on Medicines’ Risks and Label Content. Pharm Med 34, 369–380 (2020). https://doi.org/10.1007/s40290-020-00367-4

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