U.S. News


The FDA Wants This Opioid Drug Off The Market

The Food and Drug Administration wants Endo Pharmaceuticals to voluntarily remove the drug from shelves due to "risks related to abuse."
Posted at 10:32 AM, Jun 11, 2017

The Food and Drug Administration just made a major move in the fight against the opioid epidemic.

And that battle is with Endo Pharmaceuticals over a drug called Opana ER. The FDA wants Endo to voluntarily remove it from shelves over "risks related to abuse."

Opana ER was approved in 2006 to help patients manage pain. The drug's formula was updated in 2012 to keep users from manipulating it for abuse. But now the FDA says Opana ER's benefits "may no longer outweigh its risks."

This is the first time the FDA asked a drugmaker to take an opioid off the market over abuse concerns. In response, Endo said it is "reviewing the request" and "evaluating the full range of potential options" going forward.

If Endo doesn't voluntarily remove Opana ER, the FDA says it will work to withdraw its approval of the drug.

According to the most recent data from the Centers for Disease Control and Prevention, opioids killed 33,000 people in 2015.