*Please Help ARPO Fight FDA Approval of Zohydro – The Next OxyContin!

by pjackson on January 27, 2014

As you may know, the FDA recently approved a new drug called Zohydro even though the advisory committee it had commissioned to review the new drug voted against approval by a margin of 11-2.  This drug is the first form of pure hydrocodone on the U.S. market and does not contain any abuse-deterrent qualities, thus it may be easily tampered with.  This could be the next OxyContin.
ARPO and the coalition we are now a part of, Fed Up!, need your help.  At the bottom of this post you will find a letter that has been prepared to send to FDA.  Following closely on the heels of a letter from state Attorneys General from across the U.S. and also multiple letters from members of Congress, we are soliciting help from both heads of organizations, or people who can sign on behalf of an organization, advocacy group, public or private agency, business, etc.  AND individuals.  Here’s how you can help:
Heads of organizations: We will copy in electronic signatures on this letter to the Commissioner of FDA.  Our goal is to make a strong statement to FDA and the media that we will not allow the agency to continue rubber-stamping dangerous new opioid drugs in the midst of a raging epidemic.  Folks who are interested in signing should send Scarlet Gleeson with Fed Up! an electronic signature that can be digitally pasted on the final letter. If you don’t have an electronic signature, you can sign a blank piece of paper, scan the paper and email the PDF to Scarlet.  Please also include your official title.  Or, if you are not comfortable sharing your e-signature, just send Scarlet an email indicating that you would like your name, title and organization added to the letter, but without an e-signature.  Scarlet’s email is:
scarletgleeson@verizon.net  Please note that we need your e-signature by Wednesday, January 15th.
Individuals:  Individuals also have an opportunity to lend their signature to the mounting opposition to this new drug, as we have started a petition drive against the Zohydro decision.  This petition is in support of the same letter.  Simply paste the following link into your browser and it will take you to our petition in support of our letter:
As far as I know, the petition (unlike the letter) does not have a deadline, and I expect that Fed Up! will keep it up until something happens to change the FDA decision.  But sooner is better than later!  We need a fast response to initiate action that will turn this decision around. 
Thanks so much for your support, this is a very important action that every one of us has an opportunity to be a big part of.  This is the kind of action that makes ARPO so vital!  THANK YOU!


Here is the letter to FDA:

January __, 2014

Margaret A. Hamburg, M.D.


U.S. Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring. MD  20993

RE: New Drug Application NDA 202880, Zohydro ER

Dear Dr. Hamburg,

We are writing to echo concerns raised in letters written by Members of the United States Congress and by State Attorneys General regarding the Food and Drug Administration’s (FDA) approval of Zohydro, a high-dose, single-entity hydrocodone formulation. We join them in asking you to adopt the recommendation of the FDA-appointed scientific advisory panel, which voted 11-2 against approval of Zohydro.

On behalf of consumer safety organizations, health care agencies, addiction treatment providers, community-based drug and alcohol prevention programs, professional organizations, and other groups on the front-line of our nation’s opioid addiction epidemic, we ask you to put the public’s health ahead of industry interests. In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid.

If your decision to approve Zohydro was based on adherence to existing FDA policies, then surely those polices require urgent revision. FDA must take into account recent history. After the release of similar high-dose opioid analgesics, thousands of lives were lost from overdose and hundreds of thousands of medical and non-medical users became addicted. We implore you to take these painful lessons into account.

Over the past 15 years, prescriptions for opioids have skyrocketed. The United States, with about 5% of the world’s population, is now consuming more than 84% of the world’s entire oxycodone supply and more than 99% of the hydrocodone supply.[1] According to the United States Centers for Disease Control (CDC), the sharp increase in opioid prescribing has led to parallel increases in opioid addiction and overdose deaths. Since 1999, overdose deaths have skyrocketed, especially among middle-aged individuals prescribed opioids for chronic pain. Opioid analgesic overdose deaths have increased by 415% in women and 265% in men.[2]

Zohydro’s maker has claimed that it is safer than existing hydrocodone products because it does not contain acetaminophen. Zohydro is not safer. It will contain up to 10 times more hydrocodone than Vicodin or Lortab. Someone unaccustomed to taking opioids could suffer a fatal overdose from just two capsules. A single capsule could be fatal if swallowed by a child. For patients unable to tolerate acetaminophen, many opioid formulations made without acetaminophen are already available. There is no need for another high-dose, single-entity opioid.

Too many people have already become addicted to similar opioid medications and too many lives have been lost. We urge you to exercise your authority and responsibility to protect the public’s health by keeping Zohydro off the market.


[1] United States hydrocodone and oxycodone consumption statistics as reported by the International Narcotics Control Board in 2012.

[2] CDC. Vital signs: Overdoses of prescription opioid pain relievers and other drugs among women—United States, 1999–2010. MMWR 2013; 62:537-542


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