Product News and Recalls

In Wake of Crisis, FDA Targets Single Opioid for Removal

fda targets one of many opioids for removal due to abuseThe FDA has begun the process of removing a powerful opioid from the market over concerns of the potential for abuse. Endo Pharmaceuticals was recently informed by the agency that it would like to see Opana ER pulled from the nation’s shelves.

Citing concerns over the “public health consequences of abuse,” the agency is giving Endo Pharmaceuticals the opportunity to voluntarily remove Opana ER on its own. If the corporation fails to act, however, the agency has stated that it is ready to force the issue by pulling its approval.

It’s worth noting at this point that Opana was first approved by the FDA over a decade ago in 2006.

As an extended release medication, Opana is designed to slowly and steadily medicate the patient over a long period of time. However, when crushed, snorted, or injected, an abuser can get the full effect of the entire dose in one short burst. Attempts had been made by Endo Pharmaceuticals in the past to change the coating of the drug to make such abuses difficult. While successful in reducing delivery by inhalation, abusers simply turned to injection in higher numbers. This, in turn, fueled the spread of HIV and other bloodborne pathogens through the sharing of dirty needles.

While any move to try to slow the opioid epidemic’s assault on the American public can initially be seen as a positive, one can’t help but wonder why Endo, and why now? Any of the agency’s statements on the matter could be applied to any number of powerful opioids that are just as FDA-approved, just as deadly, and just as responsible for a drug abuse crisis that is almost unrivaled in its scope and impact to the nation.

“We are facing an opioid epidemic,” says FDA commissioner Dr. Scott Gottlieb. “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.”

As the agency that bears a large portion of the blame for that exact opioid epidemic, the hypocrisy of Gottlieb’s statement is astounding. Maybe Endo should work on getting one of its executives a seat on a regulatory committee. They could use their time to ask why the largest drug distributor in the United States was allowed to send enough hydrocodone and oxycodone into Logan County, West Virginia over the course of just five years to give 980 pills to every man, woman, and child living there.