Safety Issues of Drug Use: Past Lessons and Present Dilemmas

Abstract: Swiss physician and alchemist, Paracelsus, almost 600 years ago, quoted "All substances are poisons; there is none which is not poison. The right dose differentiates a poison and a remedy". The relevance of this statement is more significant than ever before. Recently, drug safety issues have come in the limelight in the wake of concerns about COX-2 (cyclooxygenase-II) inhibitors. This has thrown up disturbing questions on the efficacy of the approval systems for new drugs. The giant pharmaceutical company Merck withdrew its anti-arthritis drug rofecoxib (vioxx) from the world wide market recently due to cardiovascular risk factors. Another drug valdecoxib was also withdrawn by its manufacturer for the same reason. Rofecoxib is a prescription COX-2 NSAID that was approved by the US Food and Drug Administration (FDA) in May 1999 for the relief of osteoarthritis, management of acute pain in adults and later got nod for managing rheumatoid arthritis in adults and children. One reported estimate is that rofecoxib caused 27,785 heart attacks in the USA, and thus facing countless lawsuits.

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