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Dec-29-2013 16:25printcomments

FDA Unleashes Another Lethal Painkiller, Zohydro ER to Kill and Addict -- but with a Cruel Twist

The cruel twist is that the newly approved pure hydrocodone product, Zohydro ER will be made by the same company that manufactures Vivitrol, a drug used to treat patients addicted to opioids or alcohol.

Zohydro ER
Special thanks to motherjones.com

(MYRTLE BEACH, SC) - My recent articles have been calling the FDA out for approving a painkiller called Zohydro ER.  (Information on Zohydro ER from their website http://www.zogenix.com/content/products/zohydro.htm). This approval was given in spite of the FDA's Advisory Committee not recommending the dangerous drug be made available in the U.S.  Here is a link to my recent article on the FDA's disregard for the safety of the American people http://www.salem-news.com/articles/december132013/killer-drug-ms.php.

I have reached out to Attorneys General, the Senate and Congress to investigate the FDA to determine their interest in approving yet another painkiller -- highly addictive and capable of being abused -- adding to the painkiller epidemic we have been fighting in the U.S. and Canada.  But I'm still wrestling with why did the FDA approve this painkiller/people killer as we are waging an opioid tsunami drowning families in every state in the country.

Is the FDA involved in another "pay to play" ruse with the maker of Zohydro ER?  My answer will come when the Attorneys General, Senate and Congress get to the bottom of the hole the FDA is digging for us.

In educating myself on the maker of Zohydro ER, I learned its maker is Zogenix, Inc. headquartered in San Diego, California. It is listed on NASDAQ as ZGNX. The value of the stock is quite low currently, but it will be interesting to see the jump in the stock if the FDA does not recall it and it raises havoc throughout the U.S. and Canada.

    Zohydro ER (hydrocodone bitartrate) is an extended-release capsule indicated for the management of pain severe enough to require daily, around-the clock, long-term opioid treatment and for which alternative treatment options are inadequate. Long-term opioid treatment gives free reign for the company to market to patients for non-cancer, chronic pain and their promoting the painkiller when alternative treatment options are inadequate makes this opioid a contender for "people killer" rather than "painkiller."
    LIMITATIONS OF USE (This is off Zohydro ER's website)

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Zohydro ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

The FDA is very aware that there is no abuse resistant formula built into Zohydro ER even though the agency set up to protect the American people had indicated that opioids would only be approved with this life saving resistant formula built in.

Now here's where things get quite interesting and that "twist" comes in that I promised you.  There is a drug called Vivitrol for those who never expected to become addicted and recovery can be hard.  (Vivitrol website http://www.vivitrol.com). If opioid-dependent patients or as I call them "addicted patients" participate in counseling and take Vivitrol, they can potentially have significantly more days of complete abstinence, stay in treatment longer, report less craving for opioids, and become less likely to relapse to physical dependence -- or "physical addiction" not dependence.  And complete abstinence means people had a negative urine drug test for opioids and no self-reported opioid use.

Quite a criteria that Vivitrol uses by saying "no self-reported opioid use". Does anyone truly addicted to an opioid admit they are no longer using opioids?

The cruel twist is that the newly approved pure hydrocodone product, Zohydro ER will be made by the same company that manufactures Vivitrol, a drug used to treat patients addicted to opioids or alcohol.


So the ever diligent FDA approves a lethal painkiller set to strike in early 2014 and the company that manufactures the painkiller will offer detox treatment when patients become hooked on their narcotic -- graduating from Zohydro ER to Vivitrol for treatment of the addiction.

Law enforcement agencies and addiction experts have voiced concern that approval of a pure hydrocodone drug (Zohydro ER) will lead to an increase in overdoses, but not to worry Zogenix will be able to pull their snake oil, Vivitrol out of their medicine bag -- thanks to the deep pockets of the FDA.

There is a word I feel has been overused for years and to me is annoying. That word is "awesome". Now it appears that another expression could potentially overshadow "awesome." It is "just saying."

In the meantime, maybe the Attorneys General, the Senate and Congress should be looking at Bob Rappaport, MD and FDA's head of Division of Anesthetics, Analgesia and Addiction Products (DAAAP) stock portfolio -- it may just make the FDA accountable for bad decision making and also avoid further deaths and addictions in this opioid epidemic - just saying.

LP - A beautiful Christmas and the injectorpods ringing in 2014.  Life is good -- oh so good and so are the laughs.  Love you!
Investigative Reporter for Salem-News.com covering OxyContin and prescription drug epidemic in the U.S. and Canada

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Cliff January 2, 2014 12:51 pm (Pacific time)

Why do you even have a comment section if you just put up what you want? I put in a comment last week that wasn't unacceptable? What's up with that? What a waste of time...

Not sure about that, if it was insulting and/or off topic then it doesn't go up.  If we made a mistake in your case we do apologize.  Our goal is to publish as much as possible, but most of the people who write disrespectful comments on Marianne's articles are from big pharma and their rants are unwelcome.  I am not insinuating you are one of them, I'm just telling you how it works.  


Anonymous January 1, 2014 1:23 pm (Pacific time)

Great piece Ms. Skolek.  Thank you kindly for what you do.


David D December 31, 2013 5:42 pm (Pacific time)

This article was obviously written with a hidden agenda.

Saving human lives is not a hidden agenda.


Josh December 31, 2013 6:01 am (Pacific time)

I am a chronic pain patient. I have been dealing with massive back and leg pain for almost ten years... I've tried everything. Physical therapy, NSAIDs, injections, and much much more...eventually surgery. I have not been on opiods for ten years, but they(along with Lyrica) have greatly helped me deal with the pain. I don't abuse my medications, I use them as Rx'd. I'm deeply sorry so many families have had to deal with addiction and deaths....but those of us who deal with constant pain on a daily shouldn't have to suffer because others decide to abuse their medication.


opiates.com December 30, 2013 4:26 pm (Pacific time)

In a society where we often gravitate toward a ‘quick fix,’ it is disheartening to see that prescription drug abuse is now considered one of the leading causes of death in the U.S,this widespread problem has been dubbed as one of the largest man-made epidemics throughout history. With that in mind,it’s surprising this painkiller was approved and which could be crushed and easily abused because of no tamper resistant technology.


Justin F December 30, 2013 10:36 am (Pacific time)

The people opposing Zohydro ER don't realize that it is often less problematic than the very popular opiod drugs that have oxycodone as the active ingredient. Also..and more important is that drugs do not cause people to become addicts. People make those decisions. Addiction comes in many forms. Alcohol does not make the alcoholic. The alcoholic abuse alcohol to escape reality, create a false sense of well being etc. All drugs, alcohol, workaholics, porn addicts. over eaters. fitness freaks and so many other ways, they are all symptoms of the addict. The real problems are emotional, psychological etc. People will suffer from addiction until THEY decide to can, if ever. A new prescription pain medication, which will be a great benefit to those who suffer from constant pain, will not and cannot create addicts. The person who decides to abuse pills does so for reasons you apparently to not grasp. Another medication won't change if someone decides to get loaded. To think it does shows a complete lack of education, ignorance and most likely issues with being co-dependent.

Drugs don't cause addiction?  That is a sad joke for the families of those who fall into the trap. Good try, little pharma rep. 

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