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Affymax, Inc. Message Board

  • declaes declaes Sep 22, 2013 3:23 PM Flag

    Is this clear godwinpeak? From 61 FDA reports: Aranesp and Anaphylactic shock

    On Aug, 27, 2013: 12,714 people reported to have side effects when taking Aranesp. Among them, 61 people (0.48%) have Anaphylactic Shock.

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    • Is this clear declaes?

      One can calculate the same percentage basis for Omontys expressed as # O anaphalyctic shock incidents/O total reported incidents to compare against the .48% Aranesp percentage.

      First the number of adverse side effects reported for O by the Wall Street Journal: 12 patient deaths and 98 serious adverse events [AE]= 110 reported AEs for Omontys.

      Second, AFFY/Takeda disclosed anaphylaxis adverse incidents .2% out of 25,000 patients treated equals 50.

      Now, divide 50 O anaphylaxis AE by the 110 total O AE= 45.45%.

      Conclusion: It appears that Omontys' allergic reaction rate compared to all O AEs is 45.5% compared to the Mircera .48% allergic reaction rate compared to all Mircera AEs. O's incidence of anaphylaxis out of total adverse incidents is about 100 fold higher than Arenesp's.

      Indeed, this cursory analyis reaffirms the results previously calculated and reported by Raymond Baird analyst Christoper Raymond. In his research report, published soon after O's recall, he determined that "[L]ooking at FDA’s adverse event database for Epogen, Omontys appears to confer a 100-fold higher incidence of hypersensitivity and an 8.5-fold higher incidence of drug-related death (and that’s new)."

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