Communicating Drug Safety
Lilly communicates safety findings to regulators, patients, and/or healthcare providers - whether favorable or unfavorable to a Lilly product. Lilly attempts to provide information appropriate to each audience in an accurate, objective and balanced manner, in order for physicians and patients to make more informed decisions about Lilly products.
Communicating to Healthcare Providers and Patients
When safety surveillance activities lead to a change in the benefit/risk balance of a product, this change is communicated to healthcare providers and/or patients through the following:
- Updates to the Investigator Brochure and/or informed consent document for clinical trials
- Revision of labeling (package insert) for marketed products
- Providing safety information to physicians via Dear Healthcare Professional Letters, to consumers via Patient Package Inserts and Medication Guides, or to the public via press releases