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Vermont Becomes Second State to Take Action Against Zohydro Prescribing

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Following the decision by Massachusetts Governor Deval Patrick to order a ban on prescribing and dispensing the pure hydrocodone painkiller Zohydro, Vermont’s governor announced an emergency order to make it more difficult for doctors to prescribe the drug.

Vermont Governor Peter Shumlin said he joins the many critics of the drug, who are wondering why the Food and Drug Administration (FDA) approved it, according to the Associated Press. “What puzzles all of us is the recent FDA action to approve a new opiate that’s stronger and likely to be even more addictive because of its strength,” he said.

In January, Shumlin spoke about Vermont’s “full-blown heroin crisis” during his State of the State address. He focused his entire speech on drug addiction and its consequences.

When Governor Patrick announced the Zohydro ban, he cited a public health emergency stemming from opioid abuse. Zohydro is designed to be released over time, and can be crushed and snorted by people seeking a strong, quick high. It was approved for patients with pain that requires daily, around-the-clock, long-term treatment that cannot be treated with other drugs. Other hydrocodone drugs on the market, such as Vicodin, also contain acetaminophen.

In December 2012, a panel of experts assembled by the FDA voted against recommending approval of Zohydro. The panel cited concerns over the potential for addiction. In the 11-2 vote against approval, the panel said that while the company’s manufacturer, Zogenix, had met narrow targets for safety and efficacy, the painkiller could be used by people addicted to other opioids, including oxycodone.

Zogenix announced it will assemble an oversight board designed to spot misuse of the drug.

The FDA’s decision to approve Zohydro has been criticized by some legislators and public health groups. FDA Commissioner Margaret Hamburg has received letters protesting the decision from 28 state attorneys general and four senators, among others.

2 Responses to this article

  1. Avatar of Justin
    Justin / April 15, 2014 at 12:35 pm

    You guys are all so worried about zohydro and getting it banned but insist on giving recovering addicts drugs like methadone and suboxine which are no better than the drugs that they were trying to get off of, both drugs still get you high and both can still be abused. You don’t get taken off these drugs instead stay on the same dosage for years or increase your dosage and after awhile you are now addicted to these drugs which were supposed to be there to help you get clean but instead get you hooked on methadone or suboxine which I have heard from close friends of mine that it is harder to get off of these then any prescription pain killers or street drug, they were on suboxine program for 7 years and never tapered off but instead had their doses increased because they had built up a tolerance to the drug. When they asked to be tapered off their doctor said that it wouldn’t be a good idea, so after years of being stonewalled they decided to taper themselves off and started to decrease their dosage over a year time. They are both clean today and have been off suboxine for 2 years now but have lasting effects from being on suboxine for so long, body aches, trouble sleeping, no energy, among other problems. So I think the state of Vermont should stop putting so much energy into getting zohydro banned when everyday you give recovering addicts drugs for their addiction that are far more dangerous and harmful and you all think that it is ok including gov peter Shumlin he signs new bills all the time to get more funding to get more Vermonters hooked on methadone or suboxine good job peter shumlin you have solved nothing, I hear about suboxine and methadone being sold and abused everyday by people in Burlington Vermont most people doing drugs in Burlington are doing suboxine or methadone. So all this said stop worrying about some new painkiller that can actually help people who need around the clock pain management and start dealing with the real problem which is the drugs you supply to our streets why don’t you think about that one Gov. Peyer Shumlin

  2. Avatar of Michael Schubert
    Michael Schubert / April 14, 2014 at 11:12 am

    How is Zohydro “more lethal” than generic Opana, hydromorphone, Roxicodone, methadone, morphine, or fentanyl, all more potent opiates on the market when compared mg to mg with Zohydro?!?!? I’d really like to know. Here’s the facts below. Every single one of the 100 MILLION pain patients in this country wish reporters would do more accurate journalism.
    This hydrocodone in Zohydro, hydrocodone bitartrate, is the EXACT SAME HYDROCODONE as in all the hydrocodone products on the market now that are Schedule III substances classified by the DEA. First of all, out of all the extended release opiate pain medicines on the market, Hydrocodone, the main ingredient in Zohydro, is the LEAST POTENT milligram for milligram. This can easily be verified by looking at an opiate conversion chart, such as here: http://www.globalrph.com/narcotic.htm . I found it shocking to read so many articles, many of which were commented on by doctors, that failed to use proper drug comparisons. Oxycodone is almost twice as strong as hydrocodone, which means Zohydro is a much weaker substitute for oxycodone (which is already on the market). The anti-Zohydro groups need to pay attention and understand the significance of this truth. Every Zohydro prescription will take the place of a more potent opiate. Wouldn’t doctors want to start patients that need opiate therapy on the least potent med first? Another potent opiate, generic oxymorphone is widely available without abuse-deterrent features and much, much cheaper than Zohydro. Oxymorphone is approximately twice as potent as oxycodone. It is more lipophilic than morphine, allowing for a faster onset of action. It is available as an injection and as oral formulations: immediate-release (Opana) and sustained-release (Opana ER). Because it has a longer half-life than morphine, hydromorphone, and oxycodone, the immediate-release product may be dosed at longer intervals (up to every six hours).
    According to USA Today, Opana overtook oxycontin as the painkiller most abused in the U.S. I would assume that the activists who are protesting Zohydro would protest these much more potent drugs before complaining about Zohydro.
    Read about Opiate medications here from US PHARMACIST: http://www.uspharmacist.com/continuing_education/ceviewtest/lessonid/105473/
    Morphine, which is available in strengths up to 200mg and DOES NOT have abuse-deterrent features, must be one of the alternative medicines they are talking about. Morphine is 3 TIMES MORE POTENT WHEN INJECTED. So crushing a 200mg Extended Release Morphine tablet and injecting it would be just like taking 600mg orally!!! According to the math in the articles by reporters, this would KILL SIX PEOPLE. Any mention of Extended Release Morphine without tamper-resistant features? Actually, there is only ONE extended release opiate with abuse deterrents approved by the FDA, Purdue’s OxyContin. What they don’t tell you is the deterrent is made from a plastic polymer and causes severe side effects. Google “new OP OxyContin pain side effects” and read accounts from THOUSANDS of pain patients that suffered from the re formulation in pain forums. What about hydrocodone? Per US PHARMACIST, “Hydrocodone is only available in combination with non-opioids. Compared with codeine, it provides significantly more pain relief and a longer duration of action. Hydrocodone is a prodrug metabolized by CYP2D6, with analgesic effects dependent on its active metabolite hydromorphone.” Hydrocodone needs to pass through the liver to create the active metabolite, injecting or snorting does not create a “rush” because the active metabolite has not been created yet. Other drugs such as Vyvanse use this method to PREVENT abuse. Ever wonder why legitimate medical injectable hydrocodone has never been on the market? Because it needs to pass through the liver first. An addict injecting hydrocodone would still get high, but no “rush” like from injecting morphine, oxycodone or oxymorphone. Hydrocodone is water-soluble and passes through the blood-brain barrier slower. At 80% oral bioavailability, injecting or insuffilating hydrocodone is pointless, except on a full stomach. In comparison, Morphine is between 20-40% bio available orally, that’s why addicts inject morphine and others because it’s MUCH stronger and NOT WATER SOLUBLE.
    So why did the advisory board vote against this? They were tasked with determining its SAFETY WHEN TAKEN AS DIRECTED AND EFFECTIVENESS. During the hearing, the FDA could be heard numerous times telling this advisory board to get back to their task, not giving opinions that were not their jobs. Abuse deterrent features can be defeated ridiculously easy, google “OxyContin microwave”. The FDA has recently stated that it does no good to label something abuse deterrent if it does not do that, and it does absolutely nothing to stop the far most common route they abuse it, taking the drug ORALLY INTACT. Authors also fail to mention the other strengths of Zohydro. It comes in 10,15,20, 30 & 40 milligram strengths also, and is released OVER THE COURSE OF 12 hours. So instead of taking one or two hydrocodone/APAP pills every 4 hours, the Zohydro patient takes ONE every 12 hours. One monthly prescription for 60 Zohydro pills replaces 360 hydrocodone/APAP pills!!!! Zohydro takes 6 times as many hydrocodone pills out of circulation! Isn’t this what abuse crusaders want?!?!
    So why are people like Sen Manchin of West Virginia trying so hard to get Zohydro off the market? Let’s see, The political charge against Zohydro is currently led by Senator Joe Manchin (D-WVA), who is the father of Heather Manchin Bresch. Ms. Bresch is the CEO of Mylan (MYL), which coincidentally manufactures generic hydrocodone – a direct competitor to Zohydro. Is this not a conflict worthy of our attention? Mylan Pharmaceuticals also happens to be Manchin’s #2 campaign contributor! Source: https://www.opensecrets.org/politicians/summary.php?cid=N00032838
    Mylan sells Hydrocodone/APAP, ONE OF THEIR TOP SELLERS, and would lose significant market share to Zohydro. A United States Senator has significant political pull, notice how no other opiate (especially hydrocodone/APAP!) was under scrutiny even though some like Fentanyl are mixed with heroin and is 300 times more potent than hydrocodone? Mylan makes those opiate medications! Also Purdue makes $600MILLION per quarter from OxyContin and would lose major market share to Zohydro. Purdue makes political contributions, funds patient advocacy groups and hires teams of medical professionals as consultants.
    What about Zohydro? No one mentioned that Zogenix provides a locking pill bottle, an extremely inexpensive medicine safe ($15), and a subscription to Pain Patient Magazine (includes tips how to manage pain, safeguard medications, monitor medicine intake, etc). How many other drug companies include items like these with their opiate prescriptions? NONE! So by taking this off the market, these officials, reporters, crusaders, etc would rather have pain patients such as MYSELF take more potent medicines that don’t include items to safeguard my prescription? After reading all the FACTS above, and checking them out yourself, why do you think the real reason certain individuals want Zohydro, the least potent extended release opiate that includes ways to safeguard the medicine, off the market?!?

    Michael Schubert

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