Safety Matters

Pharmacovigilance is the process of collecting, monitoring, researching, and evaluating information from healthcare providers and patients for the purposes of understanding and preventing drug-related problems.

• Lilly's pharmacovigilance system collects data throughout the lifecycle of each marketed product. This system helps to continually evaluate and maintain product safety. When important safety issues arise, Lilly issues updated communications to doctors, patients and health regulators.
• At the initiation of clinical trials, the safety profile of the product is developed from animal data (e.g., toxicology studies) and generalizations from drugs in the same pharmacological class. This information is provided to clinical trial investigators in the Investigator Brochure . From the first human dose and throughout the course of clinical trials, safety information is collected and reviewed by Lilly staff to provide the most-up-to-date information possible about the safety profile of Lilly products.
• At the time of marketing approval, safety data from the clinical trials and non-clinical studies are summarized in the approved labeling (i.e., the package insert for the product). Post-marketing studies may be conducted to continue to collect information about benefits and risks of the product.
• In addition, healthcare providers and patients spontaneously report adverse events as a result of their experiences. These reports are taken seriously by Lilly. Each is reviewed and follow up contacts are initiated when additional information is needed.
• Data from post-marketing studies and spontaneous reports are reviewed periodically, and when new information suggests that there may be an important new safety issue emerging (i.e., a " signal "). If analyses of the collective safety information indicate a change in the benefit/risk profile of the product, then Lilly's risk management programs are initiated.
• These risk management programs include communications in the form of updates to the package insert, letters to healthcare providers, and notification to regulators. After discussions with regulators, these risk management programs may include a broader series of communications directed to healthcare providers and to patients as well as additional programs, for example that limit distribution of the product and to further evaluate the product's safety through additional studies.