Following our December 2013 post, the audacity and brazen push to release Zogenix’ uber-opioid pain-killer Zohydro ER, in spite of its known high potential to cause fatal overdose, is given the FDA blessing.
Manufactured by Zogenix, presented to the FDA in October 2010, Zohydro ER is highly addictive and, as an opioid is akin to heroin, derived from the opium poppy plant. The not-so-underlying message in this headline is the money-grab. But hey,who cares if pill addicts running to this stuff OD and croak? Junkies choose the lifestyle, don’t they? Well, then they deserve what they get!’ Right?
The question in the wake of my December 2013 blog post, namely, ‘who watches the watchdog?’ is now made obsolete and trumped by a few new ones, now that it seems the FDA is sticking to its green light determination for Zohydro ER and Zogenix.
Has anyone in legal at Zogenix, or for that matter on the taxpayer’s payroll at the FDA done a respectable due diligence on this product? Who, if anyone, has thought to inform our ivory tower, holier-than-patient medical community of the behavioral health, law enforcement and collateral repercussions when this med is stolen from acute pain patients in assisted living communities? Who is going to pay for the additional rehab beds, emergency room stomach pumps, and mental health treatments for the bereaved families after the swarm of fatal overdoses start pressing hard on our suburban communities? And who will pay for the training required and the staffing, and the parity-driven 25% – 40% pay raises to substance abuse counseling personnel when they have to clean up the mess after Rx Zohydro ER is raided from granddad’s medicine cabinet? Who pays for increased narcs to find and collar the unscrupulous Drs. Feelgood who’ve been Swiss banking their quadrupled script sales revenues?
Not your problem? Just wait till your little Tabitha or Jessica gets hold of this stuff.
A quick thanks to NEWSER and Arden Dier, who posted the following on February 28, 2014. It bears repeating in entirety for the red flag it raises.
Zohydro, which the FDA gave the green light in October against the advice of its advisory panel, will serve as a powerful pain pill for those who can’t get relief from what’s already out there. It contains the same basic ingredient (hydrocodone) as Vicodin, but it has 5 to 10 times the power, Forbes notes, and without the added acetaminophen. As an expert on the advisory board who voted “no” tells NBC News, that acetaminophen deters savvy addicts from loading up on Vicodin for fear of liver damage. Like OxyContin, Zohydro is a “pure narcotic”; but unlike OxyContin, the Zohydro set to be released isn’t tamper resistant, and can easily be crushed, then snorted or injected.
“In the midst of a severe drug addiction epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid,” some 40 experts wrote to the FDA in a call for Zohydro’s reevaluation. “It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule. It will kill people as soon as it’s released,” says one of those experts. But one doctor points out that “it all depends on how doctors monitor it. It could be lifesaving. But if used the wrong way, like any medication, it can cause trouble.” On that front, Forbes reports that experts say someone unaccustomed to opioids could overdose with as little as two pills, and that a single pill could kill a child.
I am curious how a compound such as Zohydro ER in 2014 could have progressed so far to release to market when so many health risks to the public have been cited. The recovery community, schools, law enforcement, judicial system, politicians, the medical community needs to be aware that if this product actually does reach the public, be prepared to put the coroner, clergy and funeral parlors on speed dial.
Ask any suburban hockey mom if the market is not already glutted with opioids; presenting ‘unforeseen consequences’ with abuses on the street by adolescents and other vulnerable populations ~ a veritable turbo-charged gateway to heroin use, addiction and death. Wayne and Monroe counties in Michigan alone have enough first hand experience with the current opioid/heroin transfer, with deadly results bordering on the pandemic, they certainly need Zohydro ER like a hole in the head.
I visited and read the warning label to the medical profession on the Zogenix website. You tell me; is it enough to deter suicide prone Generations Y and Z to refrain from playing with these pills at their next slumber party?
WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and INTERACTION WITH ALCOHOLZohydro ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions.Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow Zohydro ER whole to avoid exposure to a potentially fatal dose of hydrocodone.Accidental consumption of Zohydro ER, especially in children, can result in fatal overdose of hydrocodone.For patients who require opioid therapy while pregnant, be aware that infants may require treatment for neonatal opioid withdrawal syndrome. Prolonged use during pregnancy can result in life-threatening neonatal opioid withdrawal syndrome.Instruct patients not to consume alcohol or any products containing alcohol while taking Zohydro ER because co-ingestion can result in fatal plasma hydrocodone levels.
Who is going to call first for an independent investigation of Zogenix’ executive leadership, marketing, R&D and head counsel inquiring who signed off on this product?
Who is going to start knocking on the door of FDA with microphones, subpoenas for bank records and search warrants?
Seriously, I want to know. That legislator will have my vote. If the congressional oversight committee is successful and smokes out the criminally uninformed and callously capitalistic negotiators of this deal with enough evidence to put them behind bars, I will personally work on their re-election campaigns. UN~believable
ADDITIONAL READSBy John Fauber of the Journal Sentinel, Kristina Fiore of MedPage TodayOct. 28, 2013Read more from Journal Sentinel: http://www.jsonline.com/watchdog/watchdogreports/fda-oks-high-dose-narcotic-painkiller-zohydro-raising-abuse-concerns-b99128369z1-229484621.html#ixzz2uyi4gy5U ~ Follow us: @JournalSentinel on Twitter
Zogenix Stockholders Facing World of Pain? By David Phillips February 25, 2014 The Motley Fool http://www.fool.com/investing/general/2014/02/25/zogenix-stockholders-facing-world-of-pain.aspx
Zogenix product information: http://www.zogenix.com/content/products/zohydro.htm