Collecting Safety Information

Safety information is collected in order to monitor and maintain the safety profile of all Lilly products. The laws governing the development, manufacture and marketing of drugs and devices require collection of adverse events.

Lilly collects adverse event reports from all over the world and enters the information into a common electronic database to further evaluate the safety and risks of our medications.

In some situations the pharmaceutical company proactively seeks adverse events out after a medication is approved. This is done through additional scientific research and ongoing review of scientific literature.

Physicians and other healthcare providers play a crucial role in adverse event collection and the continuous evaluation of medications products' safety profile through:

  • Reporting adverse events to regulatory authorities (FDA) or the products' manufacturers
  • Providing basic information related to the adverse event, such as reporter, patient, adverse event and drug
  • Including any relevant information in the reports that might enable a thorough evaluation of the adverse event
  • Providing additional information when contacted by the regulatory authority or the manufacturer.

Lilly evaluates adverse events and other safety information collected from around the globe, including:

  • Healthcare Providers
  • Patients
  • Medical Literature
  • Regulatory Agencies

Other Sources of Safety Information

Lilly also monitors the impact of our medicines including reports of:

  • Outcomes of use of a medication during pregnancy (maternal and paternal exposure) and breastfeeding
  • Lack of drug effect
  • Off-label use
  • Overdose, abuse and misuse
  • Medication error
  • Suspected transmission of infectious agents
  • Potential adverse events associated with product complaints

Lilly continuously seeks new safety information about its products from many other sources, including:

  • Clinical trials
  • Epidemiological studies
  • Non-clinical studies
  • Published scientific articles
  • Active mining of Lilly's adverse event database and the FDA's Adverse Event Reporting System (AERS), using state of the art computerized tools