The FDA asked that drug-maker Endo Pharmaceuticals be shut down on June 8, 2017. stop selling Opana ER The extended-release Opana version was withdrawn due to “public health consequences from abuse.” This is the agency’s first attempt to remove an opioid from the marketplace. [1]
According to the FBI Opana ER has become a very popular drug that can be crushed, dissolved, and injected. Drug users sharing needles have fueled an epidemic of HIV and Hepatitis C as well as a serious blood disorder.
A FDA advisory committee voted in March 2017 that Opana ER’s advantages no longer outweigh its risks. [2]
FDA Commissioner Dr. Scott Gottlieb says:
“We face an opioid epidemic, a public health crisis. We must take all steps necessary to reduce opioid misuse and abuse.
We will continue to take regulatory actions when we find situations in which an opioid product’s benefits outweigh its risks, both for its intended patient population and also for its potential misuse or abuse. [1]
Endo stated in a statement, “Reviewing the request” and that the company was “evaluating all options to determine the best path forward.”
The company defended Opana ER’s ability to perform the intended purpose. It stated:
Endo, a pharmaceutical company that has demonstrated a commitment to pain management, feels a strong responsibility to improve pain care for patients while also taking extensive steps to reduce the misuse of its products.
Read: FDA Takes Significant Steps to Address the Growing Opioid Crisis
Endo has one chance to cooperate. If the company refuses voluntarily to recall Opana ER The FDA will withdraw the market approval for painkillers.
According to the FDA:
“In the interim the FDA is making health professionals and other healthcare professionals aware of the very serious risks associated abuse of this product.”
In 2006, FDA approved Opana ER. It is designed to be taken in one swallow and slowly released into the bloodstream over several hours. It can also be injected or snorted to give users a strong high.
The brain gets used to the euphoric sensations and requires more drug to provide the same level of pain relief and well being. This can lead to dependence and eventual addiction. [2]
The drug is OxyContin is twice as potent as OxyContinAnother powerful opioid, ephedra, has been a catalyst for many heroin addicts.
Read: Washington City sues OxyContin maker over Opioid Epidemic
Endo reformulated Opana ER by adding a coating to make it harder to inject or snort the pills in 2012. As the opioid crisis grew, other opioid manufacturers took similar steps. [1]
After reviewing all data post-market on Opana ER, the FDA decided to ask Endo for Opana ER’s removal from the market. It found that people were injecting the drug more than they were snorting it when Endo reformulated it. [2]
However, the move seemed to backfire as HIV, Hepatitis, and other diseases sparked from Opana ER users continued to spiral out.
Opana ER was the preferred drug for many addicts in the midst of the 2015 HIV epidemic in Indiana.
Read: Experts Say Even RX Opioids that are “Safest” can be Highly Addictive
Janet Woodcock is the director of FDA’s Center for Drug Evaluation and Research.
“We requested the withdrawal of the product from the market after we found that it had unintended and dangerous consequences.
This will prevent the public from any misuse or abuse of the product in the future. [1]
More than 33,000 Americans died from opioid overdose in 2015 than in any other year. Nearly half of these deaths were caused by prescription drugs. [2]
Sources:
[1] NPR
[2] CNN