What are Potential vs. Identified Risks?
Based on the strength of evidence, a risk may be considered "potential" or "identified (established)."
An adverse event for which there is some basis for suspicion of a causal association with the medication of interest but where this association has not been confirmed is considered a potential risk.
Within the context of Lilly's signal detection process, a potential risk represents a safety signal that requires additional evaluation. This may include more extensive follow-up on individual cases, such as active surveillance or more intensive monitoring activities. Lilly also may further evaluate the safety signal by means of additional studies (for example clinical trials or observational studies).
Identified (Established) Risk
An adverse event for which there is adequate evidence of a causal association with the medication is an identified or established risk.
All identified risks are included in the Company's Core Safety Information (CSI).