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 risk 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.
Once a product is on the market, it is still important to report adverse events. This helps ensure that healthcare providers have the best information available to make decisions about benefit and risk for a specific patient. It is important for healthcare providers to try and collect all available information when an adverse event is first reported.
Lilly wants you to report all adverse events, both non-serious and serious events, regardless of severity or outcome, associated with a medication. This helps ensure that we provide healthcare providers with the best understanding we have about the risk profile of a medication.
Lilly, the regulatory agencies, and your patients rely on you to voluntarily report adverse events so that patients can be better served.