Why Safety Matters at Lilly
The safety of patients using Lilly medicines is our highest priority
- Beginning with the discovery of a potential new drug, and for as long as it is available to patients, our goal at Lilly is to ensure that the benefits and risks of a medication are continuously monitored and well-understood by regulators, health care professionals and patients.
- Lilly supports its commitment to patient safety with a large group of scientific and medical experts whose sole responsibilities are to monitor, evaluate and communicate safety information related to our medicines. This group is known as the Lilly Global Patient Safety organization.
From discovery to market approval and beyond
Well before a medicine is approved by regulatory authorities and reaches patients, it is rigorously assessed through carefully designed clinical trials to better understand its benefits and risks. The results of these studies are shared with regulators, such as the Food and Drug Administration (FDA) in the United States, so they can conduct their own assessment before approving the drug for wider use.
However, even after thorough research in clinical trials, Lilly continues to carefully monitor for new safety findings, so safety evaluation does not stop when a medication reaches the market. In fact, the monitoring increases – through collection of information from ongoing clinical studies and reports received directly from health care professionals and patients using the medicine. 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. We share new findings and emerging concerns openly with regulators and health care professionals to appropriately manage risks associated with the use of our medicines. We also work diligently to combat drug counterfeiting, which poses serious health threats to patients.
Lilly Global Patient Safety
The Global Patient Safety (GPS) organization is a team of over 350 individuals, including physicians, pharmacists, nurses and other drug safety professionals. The process we use, called pharmacovigilance, is designed to continuously evaluate a drug’s safety profile through analysis of information that is collected from around the world. When a safety finding is identified, the GPS team works with regulatory authorities to inform health care providers and patients. This information is communicated through changes to the medication’s package insert, patient information guide; and occasionally through letters sent directly to health care providers or other means. Additional studies, when necessary, are conducted to further assess and understand the safety profile of the medication.
Accurate and up to date safety information is critical for health care providers and patients to best decide how and for whom a medication should be used. It is important for Lilly, regulators, health care providers and patients to work together to ensure that all participate in the reporting of any adverse event that might be attributed to a medication.Learn more by clicking here.
What to do if you have a concern about a Lilly Medication?
Everyone is unique; therefore, individuals may respond quite differently to the same medication. Patients should discuss the anticipated benefits and risks of a particular medication with their health care provider to make a fully informed decision about its use.
To report a SUSPECTED ADVERSE REACTION, contact Eli Lilly and Company at 1-800-545-5979, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
