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Affymax, Inc. (AFFY) Message Board

  • corebullquest corebullquest Oct 11, 2013 4:57 PM Flag

    FDA Approved Life-Threatening Drug

    This is an except from an article dated Sept. 24, 2013 for an FDA approved drug developed at Purdue.

    " Life-Threatening Respiratory Depression
    Respiratory depression, including fatal cases, may occur with use of Butrans, EVEN WHEN the drug has been used as recommended and not misused or abused [see Warnings and Precautions (5.2)]. Proper dosing and titration are essential and Butrans should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of Butrans or following a dose increase. "

    My question to those knowledgeable on the board is, why would there be a difference from the FDA in allowing the continuing use of Omontys if Burtrans is, as indicated above, life-threatening even when used correctly? Also, in the past, the FDA has approved label changes and added a new Medication Guide to address safety issues. IMHO, Omontys should be out in the market again soon. Especially if the benefits to those ill are so great (when used properly).

    Sentiment: Buy

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    • You have somewhat answered your own question. The benefits of O to those patients who have anemia are not so great. The industry standard of care is found in Epogen, Aranesp, Procrit and Mircera. These drugs are just as effective as O with proven patient safety profiles that O cannot meet. See PEARL studies, EMA provisional opinion, WSJ reports of 12 patient deaths and 98 reported adverse incidents.

      Butrans is an opiate for chronic pain. I am not sure, but its patient safety profile may be similar to other opiates used for pain even though it may cause respiratory depression.

      It is basically a comparison of apples to oranges between Butrans and Omontys.

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