Historic 1st: FDA calls for opioid to be removed from market based on risk of abuse

RT -June 9, 2017

In an unprecedented move, the US Food and Drug Administration has requested a drugmaker withdraw an opioid pain medicine from the market due to its potential for abuse. The agency cited the current “opioid epidemic” as a catalyst for the move.

The FDA has targeted the reformulated version of Opana ER, or oxymorphone hydrochloride, for market removal, calling on its manufacturer, Ireland-based Endo Pharmaceuticals, to take voluntary steps to do so.

If Endo chooses not to withdraw Opana ER ‒ first approved by the FDA in 2006 – the federal agency said it would take steps to rescind its approval of the drug.

“We are facing an opioid epidemic ‒ a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,”said FDA Commissioner Scott Gottlieb.