AER Reporting in OxyElite Pro Hepatitis Outbreak: What Dietary Supplement Industry Can Learn

The 2013 hepatitis outbreak linked to USPlabs' OxyElite Pro dietary supplements highlighted the importance of FDA's adverse event reporting system. But it also demonstrated that the system is an imperfect one that is highly reliant on the vigilance of medical professionals and other third parties including industry. Takeaways include: *The hepatitis outbreak shows the limitations of FDA's MedWatch adverse event reporting program. *Medical and health officials in Hawaii were instrumental in identifying a potential health crisis. *Questions remain concerning USPlabs' role in monitoring and reporting adverse events to FDA.