A 2013 hepatitis outbreak linked to USPlabs’ OxyElite Pro supplement underscored the importance of FDA’s adverse event reporting system. However, an investigation into the series of events leading up to the recall of OxyElite Pro suggests there may be need for a more robust system to monitor and report adverse events.
In this episode, Josh Long, legal and regulatory editor, and Rachel Adams, managing editor, discuss:
- FDA’s response to the 2013 hepatitis outbreak including threatened enforcement action against USPlabs;
- Questions surrounding USPlabs’ role in reporting adverse events related to the outbreak;
- Examples of the industry’s noncompliance with the legal requirement to report serious adverse events; and
- The potential need for greater communication between regulatory agencies, dietary supplement manufacturers and others to improve the effectiveness of adverse event monitoring.
Links and Resources:
- AER Reporting in OxyElite Pro Hepatitis Outbreak: What Dietary Supplement Industry Can Learn
- Health Official: Consumers Reported Taking Recommended Dose of Supplements Linked to Hepatitis
- FDA Suggests ‘Causal Connection’ Between OxyElite Pro, Liver Failure
- FDA: USPlabs OxyElite Pro Linked to Hepatitis, Liver Injuries
- USPlabs Denies Ingredient Aegeline is Unsafe
- USPlabs to Eliminate Aegeline from Supplements Amid Hepatitis Probe
- USPlabs Initiates Recall of OxyElite Pro
- UPSlabs Hit with Class Action Lawsuit over DMAA, Hepatitis Outbreak
- OxyElite Pro User Sues USPlabs, GNC
- USPlabs Slapped with Second Lawsuit in OxyElite Pro Outbreak
- CDC: Nearly 100 Cases Possibly Linked to USPlabs Hepatitis Outbreak
- Hawaii Hepatitis Outbreak: Will DOJ Prosecute USPlabs?