The objective of this study was to assess adverse event risks associated with the most commonly used analgesic classes (acetaminophen, NSAIDs, tramadol, and opioids) for OA pain in the United States.
This retrospective, observational study included adverse event cases that were obtained from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database between January 1, 2001, and June 30, 2019.
This study demonstrated significantly elevated AE risks with OA analgesics in the United States, including risks for potentially serious/life-threatening AEs (e.g., hepatotoxicity with acetaminophen; GI ulceration/perforation and bleeding with NSAIDs; and withdrawal symptoms, coma, and drug overdose with tramadol and opiods).
A next generation pharmacovigilance workflow platform that allows an organization to track and resolve safety signals and inquiries.
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Validated off-the-shelf configuration based on GVP Module IX offers fast, compliant, and lean implementation, while maintaining the flexibility to meet any organization's unique needs
