FDA Approval Of “New” Painkiller Called Zohydro™ Is Insane!

fda-needs-to-be-drastically-revamped-with-less-pharmaceutical-industry-bias-and-better-and more-personel

The FDA gave the thumbs up for Zohydro™ (hydrocodone bitartrate) even though an FDA panel recommended against approval. In addition, politicians in almost 40 states tried to get the FDA to rescind approval. Why? The drug belongs to a class of pain medications called the opioids. These drugs caused death in almost 17,000 people in the US during 2010 which was a 400% increase in mortality from these types of analgesics since 1999. Something isn’t working correctly to keep these drugs out of the wrong hands.

Zohydro™ contains hydrocodone which is the same ingredient in Vicodin™ (hydrocodone bitartrate and acetaminophen). The only difference is that Vicodin™ also contains acetaminophen (Tylenol™) which can lead to permanent liver damage and death.

Zohydro’s™ claim to fame is that it’s safer since it doesn’t contain any acetaminophen. Wrong! It will cause the same addiction and a new payroll stream for drug diversion to buyers that want euphoria. In addition, overdoses will lead to respiratory depression. This means the lungs can shut down, ending life.

Zohydro™ has a much higher dose of hydrocodone than Vicodin™. The highest dose of Vicodin™ is 10 mg per tablet with that of Zohydro™ being 50 mg per capsule. More bang for your buck!


Renovating Your Mind believes that FDA approval was unwarranted because of the high abuse potential of this medication. You can take this drug out of the capsule and snort or inject it to get an immediate high. Other similar agents on the market have protective ingredients within the medication to limit this abuse potential. The FDA should have waited till a formulation was available to limit abuse.

Any ingredient that creates high amounts of dopamine (“feel good” chemical made by the body) will cause both an addiction and tolerance. Addiction means that your body will crave the drug. This creates an environment where the addicted individual will do just about anything to get hold of the medication.

nurse-jackie-from-showtime-addicted-healthcare-professionalTake a look at Nurse Jackie on Showtime to see how low a human being will go to keep dopamine levels high in the body.  As Jackie’s addiction progresses, her behavior prioritizes getting her next fix over everything else in her life.

Tolerance is the body’s way of upping the ante. After a period of time on opiates, the human system requires higher strengths of the drug to get the same euphoric effect which increases the chance of permanent organ damage and death.

The FDA has just given drug pushers another option for making fast money by diverting these medications to individuals just looking to get wasted. More people will die from abuse from this drug because of this agency’s inability to look at the downside of approval.

Reason for approval was that this medication was the only long acting opioid sans acetaminophen on the market, but not as strong as oxycodone (OxyContin™). This reasoning allowed the FDA to rationalize approval. Good job FDA, not.


You will never see the DEA (Drug Enforcement Agency) going after the FDA for approving lethal substances. It also takes an effort for undercover agents to go after physicians writing excessive prescriptions. No, government agencies go after pharmacists and drug wholesalers for filling legal prescriptions from legitimate physicians. Why? Because we are the easiest targets to bring down, so they can save face for public exposure to the whole debacle.

These types of medications should be limited rather than expanding the venues for drug exploiters that sell to anyone with the right amounts of cash. There are other alternatives that are safer and more effective for relief of severe pain.

Drug companies don’t create cures, they create lifetime patients.






Photo credit: DES Daughter / Foter / Creative Commons Attribution-NonCommercial-ShareAlike 2.0 Generic (CC BY-NC-SA 2.0)

Photo credit: Cristal Filgueiras Bittencourt / Foter / Creative Commons Attribution-NonCommercial-ShareAlike 2.0 Generic (CC BY-NC-SA 2.0)

Photo credit: DES Daughter / Foter / Creative Commons Attribution-NonCommercial-ShareAlike 2.0 Generic (CC BY-NC-SA 2.0)

Photo credit: DES Daughter / Foter / Creative Commons Attribution-NonCommercial-ShareAlike 2.0 Generic (CC BY-NC-SA 2.0)





Categories: Health, Medications, Science-Technology

Tags: , , , , , ,

16 replies

  1. Zohydro ER is a 12 hour medication vs 4 hour Vicodin option. Agreed there is abuse potential, as there is with abusing an opioid short or long acting. Classifying Zohydro as C-II is a start with the greater restrictions. You may want to turn your attention to Purdue Pharma’s ‘HYD’ which is up to 120mg of hydrocodone (24 hour option). It does have an abuse-deterrent which are only mildly effective as per the NEJM.

    What is your proposed solution for those in chronic pain in which other treatments are not effective?


  2. Reblogged this on By the Mighty Mumford and commented:


  3. Your article puts forth very good reasons as to why we should all do our best to avoid having these types of drugs “pushed” on us by doctors looking to provide a “quick fix.” My medical condition, CAUSED by a prescribed medication, has caused so much damage that I face a life of chronic pain, one that is so bad that over-the-counter meds like Tylenol and Advil don’t even come close to providing relief. My doctor (now FORMER doctor) tried to prescribe heavy duty pain meds, which I refused and will continue to refuse. I fully believe that between exercising mind-over-matter and the use of hypnosis, pain can be controlled to at least a bearable level, WITHOUT the deadly side effects.


  4. Reblogged this on Simvastatin Nightmares and commented:
    Very informative post. A recommended read.


  5. The FDA has way too much power and lately they do not seem to wield it for the public good.


  6. Please visit my blog and read my story about my Simvastatin Nightmare…. http://simvastatinnightmares.wordpress.com/


  7. Thanks so much for your insight ! As always-excellent info.


  8. The support for your opinion is Nurse Jackie? Your mind needs some renovating.


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