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Petitioning Commissioner U.S. Food and Drug Administration Margaret A. Hamburg, M.D.

Reconsider Approval of Dangerous New Opioid Zohydro


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.

Attached 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 signatures from concerned individuals, heads of organizations, or people who can sign on behalf of an organization, advocacy group, public or private agency, business, etc.  By launching this petition, we can 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.

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.

This petition is brought to you by The FED UP! Coalition. We are a grass roots movement comprised of passionate individuals and organizations advocating for an end to the epidemic of addiction and overdose deaths attributed to opioids (including heroin) and other prescription drugs.We held our first official rally on Oct 1st, 2013, at the Nation's Capitol in Washington, DC. SAVE THE DATE for 2014: September 28th - Rally on the National Mall followed by Survivors March to the White House.

This petition was delivered to:
  • Commissioner U.S. Food and Drug Administration
    Margaret A. Hamburg, M.D.

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