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FDA Requests Opana ER Be Removed From the Market

June 12, 2017
The agency is seeking voluntary removal based on "its concerns that the benefits of the drug may no longer outweigh the risks."

Comments by Jeffrey Fudin, PharmD, DAAPM, FCCP, FASHP

The Food and Drug Administration (FDA) has requested that Endo Pharmaceuticals voluntarily remove Opana ER (oxymorphone hydrochloride) from the market. "After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks," according a press release issued by the FDA.1

According to the FDA, 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 decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal (snorting) to injection following the product’s reformulation. "Intravenous abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of thrombotic microangiopathy. This decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks," noted the agency.

Not all pain physicians understand the FDA's decision. According to Jeffrey Fudin, PharmD, DAAPM, FCCP, FASHP, oxymorphone is one of a few opioids that only undergo Phase II metabolism, and therefore avoids cytochrome (CYP) metabolism. "I'm concerned that for providers that are less familiar with the intricacies of various opioids, they may switch to hydrocodone or oxycodone without giving thought to the metabolic differences from patient to patient, and the various drug interactions that are important for CYP drugs for legitimate patients on multiple medictions." 

In addition, Dr. Fudin, who is president and director, Scientific and Clinical Affairs Remitigate LLC, and a clinical pharmacy specialist at the Stratton Veterans Affairs (VA) Medical Center in Albany, New York, noted that he was surprised that the agency is requesting removal of Opana ER because a small subset of people, mostly in Tennessee, that are using it in a way other than intended.

"What about the generic oxymorphone ER, which is also not abuse-deterrent and has a much higher incidence of snorting and IV drug use? So while the FDA no doubt will reduce thrombotic microangiopathy caused by Opana ER, increased IV use and increased snorting of the generic product will increase overdose deaths, and HIV / Hep C should remain the same," he added. 

First Approved in 2006

Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. In 2012, Endo replaced the original formulation of Opana ER with a new formulation that was intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting.

While the product met the regulatory standards for approval, the FDA determined that "the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the company’s request to include labeling describing potentially abuse-deterrent properties for Opana ER."

The FDA has requested that the company voluntarily remove reformulated Opana ER from the market. Should the company choose not to remove the product, the agency intends to take steps to formally require its removal by withdrawing approval. 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, said the statement from the FDA.


Last updated on: June 12, 2017
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A Brief History of the FDA’s Role in the Ongoing Effort to Ensure Safe Opioid Use