THIS Opioid Painkiller is Removed From Market by FDA! Read Why!
You know the Opioid painkiller medication Opana ER right? Well the U.S. Food & Drug Association, FDA has requested that Endo Pharmaceuticals remove from the market their reformulated oxymorphone hydrochloride. In fact, FDA for the first time asked to remove a previously approved medication.
The FDA found that it is an easily abused drug and there is a risk of Opana ER which currently outweigh the benefits.
Scott Gottlieb, FDA Commissioner, states:
“We are facing a public health crisis or opioid epidemic. We have to take all unavoidable steps in order to reduce the range of this opioid painkiller misuse and abuse. In future, we will continue to take steps in order to regulate this. Unfortunately, there are situations where an opioid product’s risks are more frequent than its benefits. And this is not only for its intended patient population but also taking into consideration its potential for abuse or misuse.”
The first approval of the painkiller Opana ER for use was in 2006.
The purpose of taking this medication is to regulate moderate to severe pain. Endo Pharmaceuticals in 2012, changed the formulation to make more difficult physical and chemical alterations. In fact, it was an effort to make this painkiller more difficult to abuse. However, the FDA found their steps were not good enough.
“The manipulation and abuse of “the new version” of Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had unintended dangerous consequences, we actually made a decision to request its removal from the market. This action is good and it will protect the public from further potential for abuse and misuse of this painkiller product.”
Diseases linked to Opana ER abuse include hepatitis C, HIV and thrombotic microangiopathy which is a serious blood disorder.
This two year old news report shows how serious this problem is and how long it has been going on.