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Dec-13-2013 20:55printcomments

Does the FDA Have a 'Rapport' With Yet Another Pharmaceutical Company by Unleashing a Killer Drug on Us?

Zohydro ER will come in doses close to 10 times more heroin-like narcotic than other hydrocodone painkillers.


(MYRTLE BEACH, SC) - A lethal painkiller named Zohydro ER will be available to be prescribed in 2014 after the FDA's reckless approval of it. If you think OxyContin crippled the country in deaths and addictions, be ready for further devastation of families when Zohydro ER hits your pharmacies and finds it way onto the streets by over-production of the drug.

This week 29 Attorneys General sent a letter to the FDA (click on link to read letter FDA Commissioner Margaret Hamburg) asking them to "reconsider" approval of Zohydro ER.  Reconsider?  Why was it approved to begin with especially after the FDA's Advisory Committee recommended it not be approved because of the danger of the painkiller and its abuse capabilities.  Is your Attorney General one of the 29 on the below list -- and if not why? 

Florida - Pamela Jo Bondi
Georgia - Samuel Solens
Kentucky - Jack Conway
Alaska - Michael Geraghty
Arizona - Tom Horne
Arkansas - Dustin McDaniel

Connecticut - George Jepsen
Delaware - Joseph "Beau" Biden III
Guam - Lenny Rapadas
Hawaii - David Louie
Illinois - Lisa Madigan
Indiana - Greg Zueller
Iowa - Tom Miller
Maine - Janet Mills
Maryland - Douglas E. Gansler
Massachusetts - Martha Coakley
Michigan - Bill Schuette
Mississippi - Jim Hood
Nevada - Catherine Cortez
New Hampshire - Joseph Foster
No. Carolina - Roy Cooper
Oregon - Ellen F. Rosenblum
Pennsylvania - Kathleen Kane
Rhode Island - Peter Kilmartin
So. Dakota - Marty Jackley
Tennessee - Robert F. Cooper, Jr.
Utah - Brian Tarbet (Acting)
Vermont - William H. Sorrell
Washington - Robert W. Ferguson

Zohydro ER will come in doses close to 10 times more heroin-like narcotic than other hydrocodone painkillers. It will have the capability of being crushed, chewed or mixed with alcohol -- and will deliver a swift and crippling punch at one time -- especially since there is no abuse preventative formula built in.

In the Attorneys General letter to the head of the FDA, Dr. Hamburg they make a couple of very powerful statements --

"We believe your approval of Zohydro ER has the potential to exacerbate our nation's prescription drug abuse epidemic because this drug will be the first hydrocodone only opioid narcotic that is reportedly 5 to 10 times more potent than traditional hydrocodone products and it has no abuse-deterrent properties."

"We hope that the FDA either reconsiders its approval of Zohydro ER, or sets a rigorous timeline for Zohydro ER to be reformulated to be abuse-deterrent whose working with other Federal agencies to impose restrictions on how Zohydro ER can be marketed and prescribed."

You may wonder how the FDA could approve another opioid when the U.S. is fighting a tsunami of deaths, addiction and abuse currently to the opioids they had previously approved. You may also wonder why the FDA has an Advisory Committee to review and approve the safety of drugs to be unleashed on the American people. In the case of Zohydro ER, the Advisory Committee voted 11–2, with one abstention, to recommend that the agency refuse to approve Zohydro ER because of concerns about the risk of misuse and abuse and the resulting potential impact on public health. The FDA, in its approval of Zohydro ER, said “that the benefits of this product outweigh the risks." Morgan Liscinsky, an FDA spokeswoman, said that advisory meetings for new drug approvals happen often and that the FDA is not obligated to follow Advisory Committees’ recommendations.

Last week I wrote an article about the FDA approving a very dangerous narcotic which was to be launched in 2004 by the maker of OxyContin.  The drug was called Palladone.  I sent faxes and emails to all Attorneys General, Senators and Congress alerting them to the reign of death and addiction this country would be facing if they did not take action.  Shortly after, the FDA took unprecedented action and pulled Palladone off the market.  Here is a link to last week's article

Below is the media release made by the FDA in 2005 announcing that Palladone was being taken off the market:
July 13, 2005
Media Inquiries:
Suzanne Treviño,
Consumer Inquiries:


FDA Asks Purdue Pharma to Withdraw Palladone for Safety Reasons

After acquiring new information that serious and potentially fatal adverse reactions can occur when Palladone (hydromorphone hydrochloride) extended release capsules are taken together with alcohol, the U.S. Food and Drug Administration has asked Purdue Pharma L.P., the makers of the drug, to withdraw it from the market.
Palladone is a once-a-day pain management drug containing a very potent narcotic. New data gathered from a company-sponsored study testing the potential effects of alcohol use shows that when Palladone is taken with alcohol the extended release mechanism is harmed which can lead to dose-dumping. Dose-dumping is a term that describes the rapid release of the active ingredient from an extended release product into the blood stream. The consequences of dose dumping at the lowest marketed dose (12 mg.) of Palladone could lead to serious, or even fatal, adverse events in some patients and the risk is even greater for the higher strengths of the product. As a result of this potential serious safety risk, the FDA has asked Purdue Pharma, and they have agreed, to suspend all sales and marketing of Palladone in the U.S. pending further discussions with the agency.
"All powerful pain management drugs have serious risks if used incorrectly, but the current formulation of Palladone presents an unacceptably high level of patient risk" said Dr. Steven Galson, FDA Acting Director of the Center for Drug Evaluation and Research. "Although we have not received reports of serious problems, this product has so far been used in a relatively small number of patients. We are concerned that as more patients take this drug, safety problems will arise since even having one alcoholic drink could have fatal implications.”
The current labeling for Palladone, approved in September, 2004, already includes the standard opioid warning against the use of alcohol and Palladone. However, the FDA does not believe that the risk of serious, and potentially fatal, adverse events can be effectively managed by label warnings alone and a risk management plan.
Patients currently taking Palladone should consult with their physicians for alternative treatments. For additional information, please go to:
Since every state in the country is falling victim to the painkiller epidemic in death and addiction, I would expect that 50 Attorneys General would be demanding the FDA pull Zohydro ER off the market before its launch in 2014.  I would also not be asking the FDA to "reconsider" the approval of Zohydro ER.  I would be asking who at the top in the FDA has a "rapport" with the maker of yet another killer drug -- and we don't have to wait to see how dangerous Zohydro ER is -- the FDA Advisory Committee has already told us.
LP - I saw Kermee go through the screen twice - forgot to tell you.  Don't fret - Kermee still loves you and so do I.



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