The FDA, U.S. Food & Drug Association, has requested that Endo Pharmaceuticals remove their reformulated Opana ER (oxymorphone hydrochloride) opioid pain medication from the market. This is the first time the FDA has ever asked for removal of a previously approved medication.
Opana ER was first approved for use in 2006 for management of moderate to severe pain. In 2012, Endo Pharmaceuticals changed the formulation to make chemical and physical alterations more difficult. This was in an effort to make Opana ER more difficult to abuse. However, the FDA found their steps were not good enough.
The FDA found that the risks of Opana ER currently outweigh the benefits because it is an easily abused drug.
FDA Commissioner Scott Gottlieb, M.D. states:
“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.”