COX-2 inhibitors: Communication of accumulating risk evidence and a product withdrawal

Amy Rogers (Lead / Corresponding author), Kerr Grieve, Thomas M. MacDonald

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

This chapter reflects on one of the biggest product withdrawals in pharmaceutical history, known as the “Vioxx story”, and explores the discovery of cardiovascular risks with rofecoxib, the active substance in Vioxx®, and other COX-2 inhibitors, and the way that these risks were communicated to patients and healthcare professionals. It discusses specifically how evidence generation and communication are linked and how communication challenges arising from evidence accumulating over time demanded a need to frequently communicate to the public updated information. Examples from different countries and the impact on the World Health Organization’s Essential Medicines List are presented. The chapter emphasises the link between the experiences of the Vioxx story and subsequent changes in the regulation of medicines in major jurisdictions, including legally mandated transparency of clinical studies. Ultimately, only with increased knowledge and communication about the safety of COX-2 inhibitors, patients can now be treated in the most effective and safe way.

Original languageEnglish
Title of host publicationCommunicating about Risks and Safe Use of Medicines
Subtitle of host publicationReal Life and Applied Research
EditorsPriya Bahri
Place of PublicationSingapore
PublisherAdis
Pages131-146
Number of pages16
ISBN (Electronic)9789811530135
ISBN (Print)9789811530128
DOIs
Publication statusPublished - 2020

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    Rogers, A., Grieve, K., & MacDonald, T. M. (2020). COX-2 inhibitors: Communication of accumulating risk evidence and a product withdrawal. In P. Bahri (Ed.), Communicating about Risks and Safe Use of Medicines: Real Life and Applied Research (pp. 131-146). Adis. https://doi.org/10.1007/978-981-15-3013-5_3