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.

May 25, 2016

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

Table of Contents

  • Viewpoint: Role of AER Reporting During Public Health Crisis

  • Hepatitis Outbreak Linked to USPlabs Supplement Shows Limitations of FDA Medwatch Program

  • In Threatening Enforcement Action, FDA Said OxyElite Pro Contained NDI

  • Former FDA Official: Agency Acted Quickly to Protect Public

  • Research Questions Conclusions That OxyElite Pro Caused Liver Illnesses in Hawaii

  • AER System Worked Well in Responding to Outbreak

  • Hawaii Department of Health Prompted FDA to Act

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