FDA Moves On Endo’s Opana ER Unlikely To Sweep Up Other Opioids

16 Mar 2017

Shift toward intravenous abuse with the reformulated long-acting opioid, coupled with reports of a serious bleeding disorder and HIV transmission, spurred US FDA advisory committee to recommend regulatory action, which could include new labeling, strict risk management measures or market withdrawal.

Endo Pharmaceuticals Inc. faces the prospect that the US FDA will request withdrawal of, or require new labeling and a restrictive Risk Evaluation and Mitigation Strategy (REMS) for, Opana ER (oxymorphone extended-release) due to issues with intravenous abuse.

However, given the unique circumstances surrounding the re-evaluation of Opana ER’s safety, there is no indication that other long-acting opioids...