On June 8, 2017, the FDA requested that the drug-maker Endo Pharmaceuticals stop selling Opana ER – the extended-release version of Opana – because of “public health consequences of abuse.” It is the first time the agency has made efforts to pull an opioid from the market due to its highly addictive nature. [1]
According to the FBI, Opana ER is becoming a popular drug to crush, dissolve, and inject. An outbreak of HIV, Hepatitis C, and a serious blood disorder have been fueled by drug users sharing needles.
In March 2017, an FDA advisory committee voted that Opana ER’s benefits no longer outweighed its risks. [2]
FDA Commissioner Dr. Scott Gottlieb says:
“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.” [1]
Endo said in a statement that the company is “reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward.”
But the company defended Opana ER for its ability to do what it is intended. It said:
“As a pharmaceutical company with a demonstrated commitment to the improvement of pain management, Endo feels a strong sense of responsibility to improve the care of pain for patients, while at the same time taking comprehensive steps to minimize the potential misuse of its products.”
Read: FDA Takes Major Steps to Address Growing Opioid Crisis
This is Endo’s one and only chance to cooperate, though. If the company refuses to voluntarily recall Opana ER, the FDA will revoke the painkiller’s market approval.
The FDA says:
“In the interim, the FDA is making health care professionals and others aware of the particularly serious risks associated with the abuse of this product.”
Opana ER won FDA approval in 2006. It was designed to be swallowed and to slowly release the medication into the bloodstream over several hours. But when it is snorted or inject, it gives the user a powerful high.
As the brain becomes acclimated to the euphoric feelings, more and more of the drug is required to produce the same levels of pain relief and well-being, leading to dependence, and eventually addiction. [2]
The drug is twice as powerful as OxyContin, another potent opioid that has led many drug abusers down the path to heroin addiction.
Source: U.S. Centers for Disease Control
Read: Washington City Sues OxyContin Maker Over Opioid Epidemic
Endo reformulated Opana ER in 2012 by adding a coating with the stated purpose of making the pills harder to snort or inject. Other opioid manufacturers have taken similar steps in recent years as the opioid epidemic ballooned into a full-blown crisis. [1]
The FDA said it decided to ask Endo to take Opana ER off the market after the agency reviewed all post-market data on the drug and found that when Endo reformulated the drug, people were injecting it more than they were snorting it. [2]
But the move seems to have backfired, as outbreaks of HIV, Hepatitis C, and other diseases sparked by people injecting Opana ER continued to spiral out of control.
Opana ER was the drug of choice for many addicts at the center of an HIV outbreak in Indiana in 2015.
Read: Even the “Safest” of RX Opioids Highly Addictive, Says Experts
Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, says:
“When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market.
This action will protect the public from further potential for misuse and abuse of this product.” [1]
In 2015, opioid overdose killed more than 33,000 people in the U.S., more than any year on record. Close to half of those deaths involved some type of prescription drug. [2]
Sources:
[1] NPR
[2] CNN
U.S. Centers for Disease Control