All drugs undergo extensive safety and efficacy studies before being released; however, these studies can fail to identify potential adverse reactions that are rare or develop over a long period of use. As a result, serious adverse reactions may not be fully appreciated until a drug has been on the market for many years.

Although the FDA monitors post-market adverse drug events through its Adverse Event Reporting System and periodic reports submitted by the drugs’ sponsors, concern has been raised about the effectiveness of the current post-market review system.

In November 2005, the Forum on Drug Discovery, Development, and Translation addressed this critical concern by convening a workshop and issuing a workshop summary exploring issues associated with the reporting of adverse drug events, and to consider how the roles of clinicians and patients in reporting such events can be enhanced.