FDA Moves to Get Opana ER Off the Market

FDA Moves to Get Opana ER Off the Market

In a surprise move that won't please Endo Pharmaceuticals, newly-appointed FDA Commissioner Dr. Scott Gottlieb says the agency is asking drugmaker Endo Pharmaceuticals to remove its opioid painkiller Opana ER (oxymorphone hydrochloride) from the market. "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," Commissioner Gottlieb said. "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." The FDA approved a new abuse-deterrent version of Opana ER in December 2011, but that formulation has failed to significantly slow abuse in the field. This March, an FDA expert advisory committee voted 18 to 8 that the benefits of the reformulated Opana ER does not outweigh its risks. The agency cited "a serious outbreak" of HIV and hepatitis C, as well as cases of a serious blood disorder called thrombotic microangiopathy, associated with widespread injection abuse of Opana ER in several states. Oxymorphone is roughly 10 times as potent as morphine when it's injected. A single Opana ER pill contains roughly a 12 hour dose for serious pain control when swallowed. So when it's crushed and injected, it's a clear invitation for overdose. And when the needles are shared by infected users, the public health threat becomes something of a disaster.

Not the first time for oxymorphone

"After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks," said the FDA statement. "This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse." The FDA's claim that this is the first time it has ever sought to get an opioid painkiller off the market due to public health concerns is simply not true. In fact, back in 1979 - 38 years ago - the very same painkiller, oxymorphone, made by the same company, Endo Pharmaceuticals, suddenly disappeared from the market. The only difference back then was that the drug was called Numorphan instead of Opana. And neither the FDA nor Endo publicly admitted that the suspension of sales had anything to do with the vicious, 20-year-long epidemic of deaths from 1959 to 1979. Whether or not the FDA and Endo owned up to it, amongst those concerned with opioid addiction and treatment it was common knowledge that all those injuries and deaths were directly attributable to Numorphan. Although the pills were gone, the Numorphan name remained as an injectable and rectal medication.

The oxymorphone back-story

How the oxymorphone pill Opana came to make its reappearance in 2006 is anyone's guess. In spite of the hideous history of pill-form Numorphan, for some reason that FDA approved Endo's new forms of the dangerous old painkiller it was now calling Opana. Five years later, in 2011, the agency approved the abuse-deterrent formulation. Back in May, 2015, Novus reported on the devastation Opana ER was causing. We described the checkered history of Numorphan, Opana and oxymorphone, and how it now was causing a new wave of overdose deaths and the spread of HIV and Hep-C - possibly the worst outbreaks in over a decade. We told how Opana ER had become the favorite among prescription opioid injection abusers in Indiana and the Appalachian states. Since then, some federal and state agencies have been working on it, but until now we haven't heard from the FDA. So when Scott Gottlieb took over the reins at the FDA a couple of weeks ago and announced that his major priority would be to do whatever the FDA can to combat the opioid epidemic, we crossed our fingers and hoped for the best. Well, it appears that Gottlieb is a man of his word. We're happy to see that one of the major players in diverted prescription opioids soon may be off the market - a market already glutted with far more opioid painkillers than are needed.

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