For First Time FDA Requests Removal of Opioid Medicine from Market

On Thursday, June 7, the U.S. Food and Drug Administration (FDA) requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER, from the market based on concerns that the benefits of the drug may no longer outweigh its risks. This marks the first time the FDA has taken steps to remove a currently marketed opioid pain medication due to the public health concerns of opioid abuse.

In a statement, FDA Commissioner Scott Gottlieb, M.D. said: “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. We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”