3 Deaths and 5 reactions ONEDAY SAME CENTER -after 25000 patients! -Still I'm not convinced for RECALL !!
Affymax had asked FDA to add a warning of possible allergic reactions to the Omontys label. And soon after Fresenius rolled out Omontys to more of its dialysis centers, it reported allergic reactions in 5 patients ONE CENTRE SAME DAY on 14th February 2013. Some two weeks later, Affymax and Takeda issued the recall.
In October AFFY asked for the labeling change, and that was before Omontys went into broader use at Fresenius and other dialysis centers. How many adverse-reaction reports should it take?