COX-2 inhibitors: exemplars of the drug-safety conundrum

Using clinical trials to assess long-term drug safety is problematic; in Australia, simple data linkage based on Medicare numbers may provide useful monitoring information

The era of pharmaceutical medicines began with the synthesis of acetylsalicylic acid (ASA) in the late 19th century. The reason for its synthesis was that natural salicylic acid was irritating to gastric mucosa, and the synthesised product less so. Subsequently, more potent non-steroidal anti-inflammatory drugs (NSAIDs) were introduced and, more recently, cyclooxygenase-2 (COX-2) inhibitors, also with a lesser risk of gastric irritation and bleeding. 1 The rapidly widespread and often prolonged use of these agents meant that even a small increase in the risk of a serious adverse event could be very significant in population health terms.