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Affymax, Inc. Message Board

  • nomorelosses nomorelosses Mar 12, 2013 12:27 AM Flag

    A Doctor's point of view: part III....continued

    3-The number of deaths, 3 in 25000 usage or 0.02%, is not large at all and some medication in use heavily right now, such as interferon or Fentanyl patches cause by far more deaths. Some other medications cause huge number of injuries and deaths over time, such as Ibuprofen, but none seem to be recalled.

    4-item 3 above is why FDA did not order the recall and this was a completely voluntary move by Affymax. But why would Affymax do this? I think there were 2 reasons. First and foremost it seems Affymax wanted to hold the higher ground and show they are a responsible company where patients welfare is of paramount importance. Second reason I believe must have been that the shear number of allergic reactions and 3 deaths all of the sudden and out of the blue all in February was so surprising that once company did not find a certain defective batch at fault that it felt obligated to stop the use in order to avoid any further injuries until the cause is known.

    5-The fact that no certain batch was found to be the culprit may actually indicate that Omontys manufacturing was most likely not the problem but possibly other agent(s) given to these patients at the same time as O most likely was/were at fault.

    6-It does not take months or years to figure out what went wrong as most likely they already have a good idea but it takes a bit longer to document the data to show proof (all they have to do find the common thread amongst those effected). Furthermore, for whatever drug is found to cause the anaphylactic reaction a simple skin allergy testing can be developed. But that may not even be needed as a single Epinepherine injection will reverse the worst anaphylactic reactions. This would be similar to Epi-pen provided to thousands and thousands of people for home use who are known to have anaphylactic reactions to certain insect bits. As such all dialysis centers need to do is to have Epinephrine stand by which all already do.


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