Prioritizing Patient Safety

As we develop new products to bring to market, evaluating product safety is of paramount importance. Our Pharmacovigilance team works to identify, understand and communicate all safety information about Endo’s products to our customers—both the prescriber and patient. This process starts with our clinical trials, where we identify adverse events and risks so that they can be shared with regulators to assess the overall risk-benefit profile and determine the product’s viability. Once approved, these risks must also be clearly communicated.

After our products get to market, we have a monitoring program that allows us to report back to the FDA and other regulatory agencies any significant side effects or safety issues that may occur. We have a responsibility to detect and report adverse events and quality complaints associated with our products, including unfavorable side effects, dosing errors, misuse, malfunctions and concerns about performance or efficacy of a product, and have an established process to do so in a timely and efficient manner, including a call center, medical information portal and email.

We also conduct post-marketing clinical trials and health economic studies to gather additional data on certain products after they have reached the market. As these studies report out we share this information with regulatory authorities, researchers and prescribers to improve the understanding of how our products are being used in real-world settings and to help healthcare professionals use our products safely and effectively.

*If you need to report an adverse event, please call:

+1-800-462-3636 for branded products or +1-800-828-9393 Par generic products