Abstract

In 2017, patients on a generic or branded antidepressant venlafaxine were switched to a new generic formulation (Enlafax). In February and April 2018, two major NZ media outlets ran stories about the new generic being less effective and causing specific side effects. This study aimed to examine the effect of the media coverage on drug side effects reported to the national Centre for Adverse Reactions Monitoring (CARM) and whether the specific symptoms reported in the media increased compared to side effects not reported in the media. We analysed monthly adverse reaction reports for Enlafax to CARM from October 2017 to June 2018 and compared adverse reports, complaints of decreased therapeutic effect and specific symptom reports before and after the media coverage using an interrupted time series analysis. We found the number of side effects and complaints of reduced therapeutic effect increased significantly following the media stories (interruption effect = 41.83, 95% CI [25.25, 58.41], p = .003; interruption effect = 15.49, 95% CI [7.01, 23.98], p = .012, respectively). The specific side effects mentioned in the media coverage, including suicidal thoughts, also increased significantly compared to other side effects not mentioned in the media. In the context of a drug switch, media reports of side effects appear to cause a strong nocebo response by increasing both the overall rate of side effect reporting and an increase in the specific side effects mentioned in the media coverage, including reduced drug efficacy and heightened suicidal thoughts. The study provides further evidence that media coverage of side effects can induce a nocebo effect. This is the first study to look at media coverage of an antidepressant brand switch. The increase in reported adverse events was higher for those symptoms mentioned in the media reports. The study provides further evidence that media coverage of side effects can induce a nocebo effect. This is the first study to look at media coverage of an antidepressant brand switch. The increase in reported adverse events was higher for those symptoms mentioned in the media reports.

Highlights

  • In 2017, patients on a generic or branded antidepressant venlafaxine were switched to a new generic formulation (Enlafax)

  • This study aimed to examine the effect of the media coverage on drug side effects reported to the national Centre for Adverse Reactions Monitoring (CARM) and whether the specific symptoms reported in the media increased compared to side effects not reported in the media

  • We found the number of side effects and complaints of reduced therapeutic effect increased significantly following the media stories

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Summary

Introduction

In 2017, patients on a generic or branded antidepressant venlafaxine were switched to a new generic formulation (Enlafax). Method: We analysed monthly adverse reaction reports for Enlafax to CARM from October 2017 to June 2018 and compared adverse reports, complaints of decreased therapeutic effect and specific symptom reports before and after the media coverage using an interrupted time series analysis. The specific side effects mentioned in the media coverage, including suicidal thoughts, increased significantly compared to other side effects not mentioned in the media. Conclusions: In the context of a drug switch, media reports of side effects appear to cause a strong nocebo response by increasing both the overall rate of side effect reporting and an increase in the specific side effects mentioned in the media coverage, including reduced drug efficacy and heightened suicidal thoughts

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