FDA move against a power opioid marks progress in addiction fight
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Many applauded the Food and Drug Administration’s recent announcement that the prescription opioid Opana ER (oxymorphone) should be removed from the market.

FDA based this decision primarily on post market analysis finding that the risks associated with the product outweigh the benefits. Critics of the FDA believe that the government agency has been too quick to approve opioids, the primary driver of today’s tragic opioid overdose epidemic. They saw this action as a welcome sign that the FDA and its new Commissioner would tighten restrictions on opioids.

The FDA took this action because its post market analysis revealed the reformulated Opana ER was increasingly being injected rather than snorted. Injecting Opana ER was also linked to the HIV and Hepatitis C outbreak in Scott County, Indiana in 2015.


While the Opana announcement may be a sign that that the FDA is increasing its vigilance over the approval of opioids, this action by itself is not the solution to the opioid epidemic. It is incumbent upon public health officials to take this one step further and address the consequences associated with misuse of Opana.


Fortunately, FDA did state in its release that it planned to alert Opana prescribers of the risks associated with the product. But a more robust response should be taken to address the risks associated with Opana, and with other prescription opioids.

In addition to alerting prescribers of the risks, FDA and other HHS agencies such as the Substance Abuse and Mental Health Services Administration (SAMHSA) should also make certain that prescribers understand what to do if they notice signs of addiction, steps that go beyond just no longer prescribing Opana to someone they suspect is misusing the opioid.

As with any other disease, at the first signs of a disorder, physicians should help guide their patients to treatment. It is foolhardy to believe that individuals who are injecting Opana will suddenly be “cured” of their opioid use disorder simply because Opana is no longer available.

A substance use disorder, including opioid use disorders, are chronic, relapsing diseases. Therefore, without treatment, the condition worsens. The stigma that is attached to people with substance use disorders can keep treatment out of reach for many.

This stigma can also affect the type and quality of care they receive. The general public, as well as physicians and other health care providers have negative impressions of people with substance use disorders. In addition, lack of adequate physician training in the disease of addiction can keep them from addressing the disease of addiction.

Prescribers who believe an individual might be in the initial stages of a substance use disorder may not know where to find the right type of treatment. Further, the physician may be concerned that their patient is involved in drug-seeking behavior which could point to involvement with larger illegal activity. Rather than cutting a patient off because of their substance use disorder, identifying signs of addiction points to a course of action, one that involves the patient and the community.

First, Opana prescribers should be made aware of ways in which they can reduce risks associated with injecting the drug. If a prescriber suspects misuse, the physician should work with the patient to find treatment and educate them on ways in which they can reduce the harm associated with misuse of the drug.

In addition to referring the individual to treatment, the physician can prescribe naloxone, an opioid overdose antidote, discuss safe injection with the patient, or refer the patient to a syringe services program for further help.

It may be some time before the drug Opana is removed from the market. But before this occurs, FDA, prescribers, and manufacturers can take steps now to reduce the risks associated with this opioid. 

Resolving the opioid overdose epidemic will take repeated intervention at many steps in the process. Certainly, preventing an opioid use disorder from ever developing is one intervention point.

But for people who are already abusing, there are other intervention points. 

And the potential removal of Opana from the market provides an opportunity for intervention, before overdoses occur.

Regina LaBelle is a public policy consultant and the former Chief of Staff and senior policy advisor at ONDCP, serving in the Obama Administration as a political appointee from 2009 to 2017.

The views expressed by contributors are their own and are not the views of The Hill.