Doctors warn new FDA-approved painkiller is deadly dangerous

File photo. (Photo by Charles Williams / News

A new painkiller set to hit the market in March is coming under heavy fire from doctors and lawmakers warning of its powerful ability to kill.

Although the opiate Zohydro was ultimately approved by the US Food and Drug administration, that endorsement went against the recommendation given by the agency’s own advisory panel. The panel voted 11 – 2 against approving the drug, but the FDA argued its availability is necessary to help patients unfazed by current medication.  

The new drug hasn’t become available yet, but a group of more than 40 doctors is hoping to preempt its release by urging the FDA to reconsider its decision. According to the letter penned by the doctors, Zohydro is five to 10 times stronger than its nearest equivalent, Vicodin, and has the potential to cause a severe rise in overdose deaths.

The doctors warned that the drug could potentially kill an individual after taking only two Zohydro capsules. A child, meanwhile, could suffer a fatal overdose from just one pill.

“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,” the letter reads.

Speaking to Forbes, Andrew Kolodny, of the advocacy group Physicians for Responsible Opioid Prescribing, was even more direct: “It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule. It will kill people as soon as it’s released.”

According to NBC News, Congressional representatives and attorney generals from 28 states have also called on the FDA to reconsider the drug’s approval.

Although Zohydro is comprised of the same ingredients found in Vicodin and OxyContin, but it’s not just the higher dose that has medical experts and lawmakers concerned. As RT reported in November, the FDA did not mandate Zohydro to follow the same abuse-deterrents that other drugs do. As a result, the drug will remain just as effective if crushed, snorted, or taken in a way other than originally intended. All this has opponents worried that Zohydro’s potential for abuse greatly exceeds that of other options on the market.

Still, some doctors believe the strong dosage would benefit a select group of patients. Dr. Zonfu Chen of the University Pittsburgh Medical Center East told NBC that Zoyhdro could be helpful to patients who cannot take pain medication outside of hydrocodone.

“The bottom line is no matter which narcotic you’re talking about, if you don’t use it right it can be abused,” Chen said. “It can be addictive. 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.”

Forbes noted that Zohydro’s manufacturer, Zogenix, has also claimed the drug does not contain acetaminophen, which Vicodin does, and therefore is actually safer to use. Others say that difference is negligible, since there are similar medications already available.

The letter to the FDA also placed Zohydro in a larger context regarding drug use in the United States. It noted that 2012 data by the International Narcotics Control Board found Americans consume more than 99 percent of the world’s hydrocodone supply and 84 percent of the global stock of oxycodone.

According to the Centers for Disease Control and Prevention, overdose deaths in the US have skyrocketed since 1999, from roughly 4,000 to nearly 17,000 in 2010.

Although the FDA only reconsiders its rulings on rare occasions, Dr. Jeanmarie Perrone of the University of Pennsylvania School of Medicine told NBC it’s possible. “There is precedent for reversing,” she said. “I think it could be reevaluated.”

11 thoughts on “Doctors warn new FDA-approved painkiller is deadly dangerous

  1. The national government should leave drugs alone.That way they wouldn’t be trafficking in drugs either on a pharmaceutical or “illicit” level instead of both.What needs to be reevaluated is our sense of personal responsibility and individual discipline.These are good things and when you don’t think so the state bails you at the expense of those who do think so.This game only works until you’ve bled the disciplined dry.Then government has no one left to rob to pay for your socialist ideals.No law is good law but natural law.No government is good government but self-government and I mean at an individual level.

  2. “According to the letter penned by the doctors, Zohydro is five to 10 times stronger than its nearest equivalent, Vicodin, and has the potential to cause a severe rise in overdose deaths.”

    These ‘doctors’ must be idiots, then. Vicodin is the WEAKEST of the prescription opiate family. I should know, I had a prescription for it for years (absolutely needed it, too) back in the ’90s. Morphine, Dilaudid, and Oxycontin are FAR more potent and dangerous than Vicodin.

    That said, the likelier it is to cause overdose deaths, the likelier it is to be approved.

    1. Yes, #1, I was just like that too. I had a couple of dr.s back in the late 70`s and early 80`s that were dilaudid and desoxyn dr.s and these new drugs like this are BS to say the least. Yea i also was on those legaly by prescription for a lot of years – yea I injected those by dr.s instruction for a few years , and that is 36 quarter grainer dilaudid every day – backn then , and i got the arms to prouve it too being a speedballer too. You obviously know what I an sayin`at that sso I need to say no more right #! so I will shut up now

      I haven`t used now simce the early 80`s yea that is right about 35 + years andstill want it but do not desire it. I jones for it but I still leave it alone brother .

      People like you and me #! know the truth .bro.!! we can use now buit we leave it alone and we know what I am talkin` about don`t we brother #! #1 we are good people

    2. Thank for sayin` what you did #1. ya got me to say what I did and that is that truth. Haven`t been to a dr. in over many years because of those years bro.

      Haven`t been sick for many years except for these last couple of weeks and that was because because of me over working my self . better now and never went to the dr.s either 🙂 and that is a fact when every one I knew said to go to that damned Dr.s 🙁
      You are good support #1 thanks bro. to say the least.
      You have been there like I have bro.

      P S #1 it is people like you that have actually saved my life my friend !! you are a real true brother #1 that does understands thoes like me and I do personally thank you

      1. Just pisses me off when the so-called ‘medical establishment’ puts out b.s. like that, digger.

        Not that they don’t lie about pretty much everything, though.

        1. Yea #1 – got me a tear drop off that and I know you know about that bro. . Maybe I need to talk later. I cannot talk right now though .

  3. Gee…this almost sounds more lethal and cheaper than heroin or cocaine and they are trying to make it legal. Unbelievable!

    “The doctors warned that the drug could potentially kill an individual after taking only two Zohydro capsules. A child, meanwhile, could suffer a fatal overdose from just one pill.”

    They are basically legalizing murder in the form of a pill. It’s like giving a cyanide pill to the public and saying it’s safe and will take away the pain. Of course it will take away the pain. YOU’LL BE DEAD!

    Wake up, Sheeple!

  4. I am sure they could make a painkiller without acetamenophin (which is bad for your insides) but not so powerful that 2 or 3 pills could kill you. Why not just make a drug like vicodin but remove the acetamenophin?

Join the Conversation

Your email address will not be published.