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Affymax, Inc. Message Board

  • mzecchini89 mzecchini89 Mar 10, 2013 3:49 AM Flag

    The facts

    I'm a current medical student and I also work in a hospital pharmacy making I.V. medications. Should this impress you? Of course not. But I will state simply that in a fast onset of an allergic reaction (anaphylactic in this case) is defined as anywhere in-between the range of 30 minutes or less to take effect. Now, realizing that other "pre medication" as well as other measures are taken for each dialysis patient there are several risk factors that could cause this reaction. In proper aseptic technique (cleaning the machines properly with alcohol), the real reason why there is a non mandatory recall on this drug is for one simple reason, precaution. Events such as death linked to any regiment of one or (especially in this case) several drugs at once must be noted. Why? This is because the F.D.A. is liable for not addressing such drug companies involved within each case. Any and all cases subject to a unexpected fatality is HEAVILY reviewed weekly by the board of directors for each hospital. Knowing all this, they were still unable to "blame" these deaths entirely or at on on this particular drug in question. To put this long winded comment in summary, the F.D.A. after extensive follow up is unable to prove or disprove whether the drug is deadly, but they still need to cover their #$%$ within the public eye.

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    • the facts are all 18000 people will be dead in five years

    • Congratulations on your education and goals. You should do well in life. As for me, I am a retired health care lawyer and former hospital general counsel among other private practice health care entities. While the O recall is called "voluntary" by Affymax and Takeda, I can assure you that this Class I recall would have been a mandatory involuntary recall had the FDA not worked with those companies to enable them to save face with the American public and its health care providers. As AFFY's chief medical officer commented during the Feb 25th conference call, the severity of the anaphalactic reactions were a surprise since the clinical trial allergic reactions were all mild. Affymax and Takeda will not be able to place O back on the market until they have demonstrated its safety profile once more to the FDA since the EMERALD studies apparently are contradicted by actual patient usage. I just wanted to make sure that you better understood how the system works.