From thalidomide to rofecoxib: Can we afford to wait and watch?

Abstract

Drug safety constitutes the cornerstone of modern therapeutics. Nowadays, the focus tends to be more on the hazards of drugs rather than on their benefits. This article describes from a healthcare professional's viewpoint the history behind two major drug disasters: thalidomide and rofecoxib and the reasons why drug withdrawals continue, taking the classic example of rofecoxib despite our safety concerns and the method to overcome those disasters in the future. The paper highlights the major steps to be followed for pharmacovigilance as an effective component of drug safety. The responsibility of healthcare professionals has ultimately to do with patient care and is to promote a culture of safe and efficacious drug use and thereby preventing future disasters related to modern therapeutics.