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Experts Voice Concern Over FDA Approval of New Hydrocodone Drug


The Food and Drug Administration’s (FDA) approval of the first pure hydrocodone drug in the United States concerns law enforcement agencies and addiction experts, who predict overdose deaths will increase, Newsday reports.

The drug, Zohydro ER (extended release), was approved for patients with pain that requires daily, around-the-clock, long-term treatment that cannot be treated with other drugs. Drugs such as Vicodin contain a combination of hydrocodone and other painkillers such as acetaminophen. Zohydro is expected to reach the market in early 2014.

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

Zohydro is potentially 10 times stronger when abused than hydrocodone combination products, according to the article. Zohydro is designed to be released over time, and can be crushed and snorted by people seeking a strong, quick high. The opioid drug OxyContin has been reformulated to make it harder to crush or dissolve, but Zohydro does not include similar tamper-resistant features, the newspaper notes.

Zogenix has started the development of an abuse deterrent formulation of Zohydro , according to a company statement.

“That the FDA has approved another incredibly powerful painkiller without [tamper-proof features] is both disconcerting and dangerous,” said Jeffrey Reynolds, Executive Director of the Long Island Council on Alcoholism and Drug Dependence, who told the FDA expert panel he opposed Zohydro’s approval without safety features. “While this drug might be a godsend for people with acute pain, it’s a potential nightmare for those struggling with or at risk for addiction.”

17 Responses to this article

  1. William / August 26, 2014 at 4:45 pm

    Let’s ban booze,no medical use.addicting and way more deaths.

  2. Scott A / August 5, 2014 at 2:34 am

    All this objection coming from people and agencies who aren’t dealing with terminal and disabling painful conditions, who are being forced to destroy their livers to satisfy the self righteous ‘experts’ and anti drug-usually religious connected-hypocrites….So something “could’be abused…So we keep making sick people get sicker and die by poisoning their meds with Tylenol, out of fear that they might get a high off off their pain relief, God-forbid-any relief from cancer, terminal illness and pain. You should all be ashamed and responsible for all the lives you made worse by insisting people “pay a price’ for pain relief ….we all understand that drugs are abused…and the failures of law enforcement to be able to totally eradicate opiate street sales shouldn’t be saddled to the backs of the legitimately sick. Repulsive and unethical.

  3. Richard / July 9, 2014 at 7:03 pm

    I do not know how you folks get your meds, but where I am, it is followed closely ,a regular Doctor does not write prescriptions for These types of strong med, I see a Pain Doctor and I had to sign a contract with him, saying I would not get any medications for pain from anyone else. I have to submite to unrine tests at random intervals .
    The most important thing, is that being monitored while on this type of drug, which means
    if you need to come off the drug , you are weened off of it, you just do not go Cold Turkey.
    When you have chronic pain, the drug eventually just evens you out, it does help the pain, but after years on any drug, you build a resistance to them, and at some point the dosage cannot be increased.
    I am on the Medtronics pain pump right now, and It does not help me much, am going to go back on oral medications at the middle of the month…Hydrocodone works very well with my system…so I am hoping for some serious pain reduction..
    Good luck to you all..

  4. Avatar of Jamie
    Jamie / April 24, 2014 at 3:19 am

    Safer for an addict to get their drug prescribed by a doctor than a dealer on the street.

  5. Avatar of Arlene
    Arlene / February 26, 2014 at 11:57 am

    Our main goal should be “management of pain”.
    If you are doling out pills, is that managing pain or “doping you up?”
    I am sure there are better and safer ways,(adicts are one thing, becoming addicted to the drug, hence becoming dependant on the, hence, becoming an addict) has to be considered.
    SAFER pain meds that DONT affect the pleasure centers of the brain are what pharmaceutical companies should be studying and formulating.

    • Scott A / August 5, 2014 at 2:40 am

      Basic pharmaceutical knowledge would dictate the two are intertwined…if what you mentioned were so easy it would have been done along time ago. people in serious pain dont get any major high of their kills pain-thats it. And most of these drugs have bad side effects that make it trade off to begin with. Its always so easy for those not experiencing it to pass people needing these drugs off as “addicts’ and ‘dope heads’ yet they aren’t the ones terminally ill , in serious pain from serious conditions, ect. its not fun being on narcotics for illness. And eventually if your on them for fun, that isnt either im sure.

  6. Avatar of The Other Guy
    The Other Guy / November 5, 2013 at 2:09 am

    Just so everyone knows, most deaths that are because of drugs containing hydrocodone are almost ALWAYS due to APAP poisoning. Not because of the hydrocodone itself. So in all reality isn’t this new “Zohydro” form of hydrocodone going to be the exact same potency? Come on, let’s not be stupid here. 20 milligrams of hydrocodone in a combination pill such as “Vicodin” is going to be just as strong as this “Zohydro” and the vicodin would of course be more dangerous than the “Zohydro” because of the APAP content. It’s impossible for the hydrocodone bitarate in a “Zohydro” to be 10 times stronger than the hydrocodone bitrate in a “Vicodin”. Do your research people and don’t just let any old person or group shove random biased crap down your throat, thank you for reading…

  7. Drajjmd / November 5, 2013 at 12:21 am

    As physicians we not only took an oath to help cure our patients but to do so while keeping them free from pain. If the ailment in question is indeed chronic pain then I applaud the industry for providing us clinicians with more effective ways at managing a patients pain. Just to put ALL of you at complete ease, hydrocodone (technically hydrocodeinone) when marketed as “Zohydro” and thus prescribed and dispensed as such (a pure hydrocodone product, it falls under the controlled substance act as a scheduled II medication which means 1) NO VERBAL orders for these CII meds 2) NO refills whatsoever which means that as soon as your 30 days is up (probably before then you’ll have to see your physician) so that he/she can evaluate your need for meds: physical therapy etc. I don’t like to see big Pharma take advantage of my patients! Particularly those in pain BUT any addition to our armamentarium in fighting pain is (weighing the positives and negatives still comes out positive for us NOT to mention the generic formulations should B around the corner

  8. Gail Chmielewski / November 4, 2013 at 12:49 pm

    I can’t believe the FDA is approving another addicting opiate drug! Why do we need a “pure” opiate out there!!! Isn’t there enough deaths?

    • Scott A / August 5, 2014 at 2:51 am

      because we need drugs with less toxic things like Tylenol in them for patients already taking drugs for cancer and other things that make their livers weak already..the fact is narcotics work, and are very effective. trust me if you are in pain, you arent taking them for kicks….they nauseate you, and make you feel bad. but they do relieve serious pain for many people. why the FDA insists on making people destroy their liver to get pain relief is beyond me. I get the whole deterrent to abuse thing….but punishing and killing people as a law enforcement tool is unethical at best..criminal more likely.

  9. PMW / November 8, 2013 at 12:54 pm

    The concern would be the same as with Oxycontin…..the drug being prescribed for any type of pain (not intractible cancer pain) and then the transition to heroin…where the ODs commonly occur!

  10. Avatar of Joseph
    Joseph / February 26, 2014 at 7:04 pm

    First off hydrocodone is way less potent then it’s cousin oxycodone. Not everyone who do opiates become full fledged Heroin addicts. 20MG extended release would hardly do anything, and it will be no different then vicodin. If someone is going to start their addiction with the new hydro extended release, then if it were not around the same person would just go and try vicodin, or oxy. or maybe oxymorphone or hydromorphone. Or heroin.

  11. Avatar of kbm
    kbm / January 25, 2014 at 11:40 pm

    The whole purpose of medication is to treat a medical condition or to lessen the pain thereof. Why should drug abusers even enter into the equation when a new effective drug is formulated?
    Addicts /Dopers will find their high somewhere, be it thru opiates, meth, acid, alcohol or any of a litany of substances &/or combinations. Do away with ten effective drugs and they will find 20 to replace them. Frankly, if they do not care about their own bodies, why should they take precedence over suffers of disease or injury?

  12. Avatar of phil miaz
    phil miaz / February 24, 2014 at 2:11 am

    Because those of us in chronic pain can get liver damage from the Tylenol in percoset or vicodin. I love it when people who know nothing of chronic pain stick their nose in the air.

  13. Avatar of Chris Ferguson
    Chris Ferguson / March 1, 2014 at 5:30 am

    There are several “pure” opiates but then your understanding of what is meant by “pure” is part of your problem. What they mean is it is hydrocodone without TYLENOL! Tylenol being the med that is killing the majority of lortab/vicodin users. Tylenol is the MUCH more dangerous drug as the government has finally aknowledged by continually lowering safe doses. Zohydro is a much safer MEDICINE than the current hydrocodone on the market. And zohydro will provide 1 more step between hydrocodone and stronger opiates, keeping patients off stronger opiates longer. And there is nothing wrong with opiates, they are not “evil”, much like a gun, pills do not kill people, people kill people. Please if you are going to take the time to make a comment at least know what u r talking about.

  14. Avatar of Chad
    Chad / February 26, 2014 at 3:19 pm

    There is such a compound known as marijuana but the FDA wont approve it because it has no physically addictive properties. No side effects and zero over doses but hey big pharma wants money more than a cure.

  15. Manda / June 20, 2014 at 7:24 am

    Fyi to the uneducated person throwing punches at addicts, it too is in fact a DISEASE!!! They are people too and you never know if you may end up with a problem. It is not like they say to themselves, “hey I wanna be an addict when I grow up.” So please either educate yourself or refrain from smug comments on something you know nothing about. Thanks. I am an addict in recovery! !

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