Food and Drug Administration Pulls Opana ER from Shelves

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

In April 2016, HEAL Blog wrote an entry about the fascinating and heartbreaking first episode of National Public Radio’s (NPR) series, Embedded. Host Kelly McEvers found a group of prescription opioid Injection Drug Users (IDUs) who allowed her to record an audio interview about their lives and how they use their drugs. The drug in question was Endo Pharmaceuticals’ powerful prescription opioid, Opana ER (McEvers, 2016). A little over a year after this broadcast, the Food and Drug Administration (FDA) reached the conclusion that the “…benefits of the drug may no longer outweigh the risks,” and have asked Endo to remove Opana ER from the market (Mandal, 2017).

What’s at stake here isn’t just a 4% increase in prescription opioid overdose deaths in 2016 (n=17,536), nor the 23% increase in heroin-related deaths (n=12,989); it’s not even the 73% increase in synthetic opioid-related deaths (n=9,580) (Stobbe, 2016). What’s at stake, at least for Endo Pharmaceuticals, is the $158 million in sales Opana ER brought in for Endo in 2016 – a 10% decrease from 2015 (Mandal). For Endo, pulling one of their most successful products from the market means a huge hit to their bottom line.

Opana ER pill bottle

Photo Source: Medcitynews.com

Opana ER, first introduced by Endo in 2006, was reformulated in 2012, when the manufacturers began adding a plastic coating to the outside of the pill to make it “abuse deterrent.” This move, while initially praised by the FDA and lawmakers as a great step forward to combating prescription drug abuse and addiction, simply shifted how drug users abused the drug. While the initial formulation could be crushed and easily snorted nasally, the plastic coating prevented this practice. Necessity (read: addiction) being the mother of invention, drug users found a way to abuse the drug by melting the plastic coating off, filtering the coating out through mesh, load the liquefied drug into a syringe, and injecting it straight into their bloodstreams. The McEvers Embedded piece literally goes over a step-by-step “How To” guide that is already known by IDUs.

The bottom line for states, counties, and municipalities who are having to cope with the 40,105 opioid drug-related deaths in 2016 comes down to more than just money – the issue is negatively impacting virtually every arena of daily life. Families are rent asunder, children are left orphaned, and emergency personnel are facing their own increased risk of overdose from inhaling or coming into direct contact with the powerful synthetic opioids, fentanyl and carfentanil, during overdose calls and drug busts. The risk of overdose due to exposure is so great that the Drug Enforcement Agency just this month issued a safety guide for first responders who might come into contact (Chanen, 2017).

Pain advocates who have long pushed for easy access to prescription painkillers argue that increasing restrictions places an undue burden upon patients who properly adhere to treatment regimens, using powerful prescription opioids as prescribed. To their way of thinking, regulations and prescribing limits unfairly limits the ability of those who live with chronic pain to function and/or go about their daily lives. Pain advocacy groups (many of which are conveniently funded by the very pharmaceutical companies whose drugs are at risk) have repeatedly, and in many cases successfully, lobbied state and Federal legislators to prevent the passage of any legislation that might hinder their access to these drugs.

I don’t buy it, and apparently, neither does the FDA. Endo Pharmaceuticals have said they’re “…evaluating the options and reviewing the situation to opt for an appropriate path forward.” Should the company refuse to remove the product voluntarily (as the FDA has asked), the agency intends to take steps to formally require its removal by withdrawing approval (Kean, 2017).

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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