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

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.