Regulatory agencies and pharmaceutical manufacturers use a risk assessment and decision making process to preserve patient safety. This process depends on the reporting of adverse events to identify potential risks of marketed medications, particularly extremely rare events that would not have been identified in clinical trials. Often, infrequent side effects can only be observed after a medication has been approved and used across a large, diverse patient population for an extended period of time.
For this reason, it is important to report adverse events once a product is marketed. The reporting of all non-serious and serious events associated with a medication, regardless of severity or outcome enables manufacturers to ensure that health care providers have the best understanding we have about the risk profile of a medication.
Lilly, the regulatory agencies, and patients rely on voluntary reporting of adverse events so that patients can be better served.