Most likely VENOFER did it and not Omontys. No wonder FDA has not touched their approval
It seems FDA knows more than we thought. These guys are like the FBI for drugs and know almost immediately who is at fault. I read the Venofer's label and in its first sentence about side effects mentions "anaphylactic reaction and fatality" and even recommends medical staff able to handle such reactions should be on hand before giving Venofer injections.
Also note that Venofer were being given to these patients at the very same time that they were getting their Omontys.
What we need now is to know when did they first began giving these patients Venofer while getting O. Was it in February? If so the investigation may have already been for the most part concluded and we may even get the news on Thursday.
I don't know about others here but I had no idea that such a medication as Venofer was being administrated to the ptients at the same time as O. Otherwise I would have probably gone all in or at least loaded up heavily. I hope to be able to do so Monday.
venofer is far safer than Omontys :
about Venofer :
Hypersensitivity side effects have included wheezing, dyspnea, hypotension, rashes, and pruritus. Hypersensitivity reactions to iron sucrose (the active ingredient contained in Venofer) are reported to occur in less than 0.1% of patients. Anaphylactic reactions consisting of anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, and/or convulsion have also been reported.
Serious hypotensive episodes have been reported in two patients following administration of iron sucrose at a dosage of 500 mg.
Between 1992 and February 2005, a total of 104 reports of anaphylactoid reactions including serious or life-threatening reactions have been collected in postmarketing spontaneous reporting worldwide based on estimated use in over 3.8 million patients.