June 9, 2017

FDA Never Should Have Approved Opana ER

Dr. Sidney Wolfe, founder of and senior adviser to Public Citizen’s Health Research Group, today applauded the U.S. Food and Drug Administration (FDA) for urging Endo to take Opana ER off the market, while criticizing the fact that the FDA approved it and blasting Endo Pharmaceuticals’ defiant response to the request.

Opana ER is an extended-release painkiller with significant injection abuse potential that has been linked to a number of deaths and hospitalizations during our national opioid epidemic, as well as an outbreak of HIV infection because of injection abuse. Wolfe testified (PDF) about the medication in March before a joint meeting of two FDA advisory committees.

Endo’s response to the FDA’s request indicated that the company would not necessarily take the medication off the market. Wolfe warned that, as a result, the company may be exposed to product liability lawsuits from those injured by the medication or their surviving families.

Even at the time of its approval, Wolfe called the FDA’s decision to approve Opana ER a “mistake.” Prior to approval, the FDA never presented Opana ER to its Drug Safety and Risk Management Advisory Committee, which might have advised rejecting it.

Read statement below:

Statement by Sidney Wolfe, MD

Founder, Senior Adviser Public Citizen’s Health Research Group

Although the FDA should be commended for asking Endo to take Opana ER off the market yesterday, two serious problems need to be addressed, one involving  the FDA, the other, Endo.

At the March FDA advisory committee meeting concerning the allegedly improved version of Opana ER (OPR or Opana ER reformulated), the FDA had provided briefing material that clearly showed the agency to have been aware, before it approved the new OPR version, that it could have injection abuse properties greater than the older form of the drug (OP). In the 4th slide of my presentation at that meeting, FDA had said that:

“… tools and methods.  OPR can be readily prepared for injection, despite Endo’s claim that OPR tablets have ‘resistance to aqueous extraction (i.e. poor syringeability)’ (Petition at 4). In addition, certain data suggest that OPR can more easily be prepared for injection that OP.” 

The agency therefore had enough evidence before approval to reject the drug as possibly more dangerous than its older OP version. When OPR was approved in late 2011, I was a member of FDA’s Drug Safety and Risk Management Advisory Committee but for inexcusable reasons, this approval decision was not presented to the Committee which might have advised rejecting the drug before it was marketed and ultimately caused many deaths, hospitalizations and a well-documented outbreak of HIV infection because of injection abuse.

In addition to FDA’s serious mistake in approving the OPR version, Endo’s defiant response yesterday that they would not necessarily take this more dangerous form of the drug off the market is reckless. In proportion to how many people will use and, in many cases abuse the drug, causing deaths, hospitalizations and other preventable between yesterday’s FDA decision and the ultimate, but certain forced removal of the drug, Endo will be exposed to many product liability lawsuits from those damaged or their surviving families.
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Endo Statement Yesterday: “Despite the FDA's request to withdraw OPANA® ER from the market, this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed. Endo remains confident in the body of evidence established through clinical research demonstrating that OPANA® ER has a favorable risk-benefit profile when used as intended in appropriate patients.”  http://www.prnewswire.com/news-releases/endo-response-to-june-8-2017-fda...

March 14th testimony: https://www.citizen.org/our-work/health-and-safety/testimony-before-the-...
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Transcript of March 14th, 2017 Advisory Committee Meeting: Dr. Wolfe testimony on PDF pages 58 to 66
https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMateri...