Public engagement and the role of the media in post-marketing drug safety: the case of Eltroxin® (levothyroxine) in New Zealand

Abstract

The potential for harms from adverse drug reactions (ADR) constitutes a critical patient safety and public health challenge, especially with increased medication usage as populations age. The research reported here explores explanations for a sudden increase in ADR reporting in New Zealand after a new formulation of a medication to treat hypothyroidism, Eltroxin^® (levothyroxine), was phased in. The formulation was adjudged to be bioequivalent to the old formulation, yet following its introduction, a sharp increase in the reporting of adverse reactions to this drug occurred. The paper analyses public engagement and the role of print media coverage, press releases and minutes of meetings of relevant agencies in order to describe the unfolding of this health controversy. Early interpretations of the sharp increase in reporting of reactions explained it as an outcome of a combination of factors, including a mistrust of state drug subsidising agencies and media attention that provoked anxiety in this vulnerable population. This paper offers an alternative explanation arguing that, as adverse drug reactions are known to be significantly underreported, the Eltroxin^® ‘health scare’ illustrates enhanced pharmacovigilance triggered by the interaction between patients and the media. The Eltroxin® controversy is an illustrative case example of the amplification of ADR reporting by patients following increased media attention in the context of a low consumer reporting environment. The case of Eltroxin^® indicates that drug safety can be enhanced by actively using media sources and by encouraging patient engagement and reporting of ADRs.

Keywords:

• Adverse drug reactions
• drug safety
• public engagement

Acknowledgement

We would like to thank Michael Tatley of the Centre for Adverse Reactions Monitoring for initial discussions and information provided about the case.