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.
- Safety evaluation does not stop when a medication reaches the market. After the completion of pre-marketing clinical trials, Lilly continues to carefully monitor for new safety findings. In fact, the monitoring increases - through collection of information from post-marketing clinical studies and spontaneous adverse event reports voluntarily reported directly from healthcare providers 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.
- Safety information continues to be assessed throughout the lifecycle of the product. New findings and emerging concerns are shared openly with regulators and healthcare providers 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.