It seems all the death happened in a single month from what I've read. This alone tells me there is no problem with the Omontys. Period.
there may have been problem with manufacturing of the product for that particular month, the administration of the iv in terms of the dose or how it was given, the effected patients co-mobidities or allergies, other medication or fluids administered at the same time, whether dialysis itself was the issue (for those on dialysis on the same day), etc etc etc.
But to repeat, there is NO WAY IN THE WORLD that OMONTYS as originally manufactured, could have been the cause as you could not possibly have had nearly 11 months and 25000 patients usage without any significant deviation from what is expected and then suddenly have get 3 deaths and many more anaphylactic
Note: I am a practicing physician nearing my retirement. I am also long AFFY as of this week.
Then how do you explain the European based PEARL studies that reported such significant adverse reactions that established that Omontys was unsafe for CKD dialysis patients generally? AFFY couldn't do it. I don't believe you can either. Until the discrepancy in safety profiles is resolved between the PEARL and EMERALD studies, then it is a relatively safe bet that Omontys will not get FDA approval to come back on the market.
Um, they still have FDA aproval. Affymax took Omanty off the shelves voluntarily. Whatever the cause , they intend to protect the Omanty patent. The cause of the reactions will be remedied. Very good work by Affymax. aimho
Note the PEARL studies showed Omontys unsafe for CKD patients not on dialysis. Like the FDA, the doctor is looking only at the EMERALD studies. The PEARL reports of significant adverse reactions were so bad, the the AFFY researches went on the record to say it would be "suicide" for AFFY to seek FDA approval of Omontys for all CKD patients.
finally some common sense and good info. from a doctor. thanks.
i said it before, the quick and swift recall will turn out to be best decision/move by affymax. they know what they're doing! i don't think a bunch of knuckleheads are running this show.