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    Zohydro Controversy
    avatar
    David Maine, MD posted:
    FDA chief defends controversal approval of Zohydro - What are your thoughts?
    http://www.foxnews.com/health/2014/03/14/fda-chief-defends-controversial-zohydra-painkiller-as-criticism-intensifies/
    Reply
     
    avatar
    blessedladyptl responded:
    If the stats are correct and hydrocodone is among the most widely abused medication, it concerns me that Zohydro has no abuse deterrent properties. Purdue is in the final stages of developing a hydrocodone extended release with abuse deterrent properties. What difference would waiting make ? The state of Mass has already ban the sale of Zohydro, if other states follow, it won't matter if the FDA has approved it.
     
    avatar
    annette030 replied to blessedladyptl's response:
    I am somewhat cynical, I think it is all about patents. If it is approved now, then the drug company can ask for a new patent when the present one is nearly up and they have a tamper resistant version available.

    Take care, Annette
     
    avatar
    blessedladyptl replied to annette030's response:
    There is a lot of confusion because hydrocodone combination meds are about to be moved from Schedule III to Schedule II. If this particular medications is as widely abused as we are being told, then why add to the problem with introducing a hydrocodone only formula that is not abuse deterrent ? There also seems to be confusion because the REMS recommended the reclassification of the hydrocodone combination meds which the FDA followed, But, the REMS also was against the approval of Zohydro, which the FDA ignored.
     
    avatar
    rosemaryauntof14 replied to annette030's response:
    I agree with you annette. I remember when I was first diagnosed with fibromyalgia. Fortunately I had a doctor who did believe that this was real and not "all in women's heads" Now there is a drug for this and all of a sudden there really is a disease. I think of that everytime I see a drug commercial. Rosemary
     
    avatar
    annette030 replied to rosemaryauntof14's response:
    I also have fibromyalgia, it is tough to live with this disorder.

    Take care, Annette
     
    avatar
    annette030 replied to blessedladyptl's response:
    Any hydrocodone product that did not have another medicine mixed in with it has always been Schedule 2 and the ones with another drug mixed in were Scedule 3. This was my understanding anyway. Only compounding pharmacies even made a stand alone product containing hydrocodone.


    What does REMS stand for?

    Take care, Annette
     
    avatar
    blessedladyptl replied to annette030's response:
    Annette, the meds containing hydrocodone and another drug will become a Schedule II later on this year. The Risk Evaluation and Mitigation Strategy (REMS) of the FDA recommended hydrocodone combination meds be moved from a Schedule III to a Schedule II is Jan 2013. In Dec 2013, the FDA ask Dept of Health & Human Services, then DHH ask the DEA to reclassify these meds. The notice of proposed changes to the Code Of Federal Regulations was published March 2014. These meds will be reclassified later on this year.
     
    avatar
    David Maine, MD replied to annette030's response:
    Risk Evaluation Mitigation Strategy - used to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if the Food and Drug Administration determines that a REMS is necessary to ensure the benefits of the drug or biological product outweigh its risks.
     
    avatar
    annette030 replied to David Maine, MD's response:
    Thanks a bunch. Do you happen to know what percentage of users become addicts as far as hydrocodone goes? Has it been figured out separately from other opiates?

    Take care, Annette
     
    avatar
    annette030 replied to blessedladyptl's response:
    Thanks for responding. I do appreciate it a lot. So, REMS comes under the FDA.

    I knew that the FDA had recommended that any drugs that contained hydrocodone should be Schedule 2 rather than the Schedule 3 that they have been.

    Since I stopped working/volunteering, I am somewhat out of the loop as far as alphabet soup goes.

    Take care, Annette


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