The Importance of Anticipating Risk
This article was originally published in SRA
Executive Summary
Three months ago, in May 2006, the US Food and Drug Administration (FDA) asked manufacturers of attention deficit hyperactivity disorder drugs to strengthen the warnings on the labels of their products to highlight the risk of serious cardiovascular and psychiatric events. Similarly, in 2004, the agency asked manufacturers of anti-depressants to add boxed warnings to their products about the increased risk of suicidal behaviour in children and adolescents. One might reasonably ask, “Why now?” Most of these drugs have been on the market for years (in one case more than 20 years) and in some cases prescribed to very large numbers of people, including for off-label use. The answer is that until recently, the regulatory community didn't look at the risk profile of a drug over time and in the context of different users. Now it does. And it's about time.