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Affymax, Inc. Message Board

  • beatendown_thensum beatendown_thensum Jun 13, 2013 8:26 AM Flag

    Fresenius centers and recall

    Omontys was launched circa march'12, give or take.... Between that time and recall, 25,000 treated. I also remember reading that the FDA had recieved approx 20 reports of anaphylaxis.. But then it seemed to surge. I believe that Fresenius stated that just prior to the recall they reported to AFFY an increase in the number of reactions, and including five in just one day, and had decided to stop it's use; thus the voluntary recall.... I did not find anything that says that those five reactions in one day, or the deaths themselves, had occurred at one location, or in one particular region. The prior report of 20 reactions of anaph to the FDA is really minor, and probably expected.. Then things seemed to blow up... I find it very hard to believe that Omontys will not be cleared. Seems to me it has to be a by-product of a manufacturing problem, or a change in Fresenius administration protocul. This is just IMO, of course, but things happened too suddenly. There is no comparison to Tysabri (which some posters have done), and those related deaths. The Omontys reactions seem to be "clumped," at least with regards to time if not location.

 
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