Boy! is the FDA nervous. The EU approved Sugammadex on Wednesday and
the next day the FDA issued its non-approval letter. At larger than
clinical dosing a few patients experienced redness around the IV and
itching. The advisory committee was awre of this and voted 9-0 for
approval. All the cases resolved without treatment( only stopping the
infusion). Cyclodextrins are very common and there are no reported
cases of analyphylaxis that I am aware of. There are in Febreeze and
are what make cholesterol free eggs. It is hard not to live in the
21Century and not be exposed to these molecules. This is truly
unfortunate. This is a life saving drug that will be available in
Europe but denied to American doctors. It is one of the cleanest drugs
I have used (only roc and vecuronium seem cleaner). Its to bad that
anesthesia is paired with rheumatology as I think they are still
recovering from Vioxx and rapacurium. I hope not many suffer morbidites
and mortalities because of the FDAs inability to accept their advisory
committee's decision.

Scott

Scott Groudine, M.D.
Professor of Anesthesiology
Albany Medical Center
Albany, NY 12208
(518) 262-8505

>>> kmpnpm@yahoo.com 8/2/2008 12:47 PM >>>
I had been waiting (expecting) for this issue to come up! The structure
of sugamaddex is one of DEXTRAN similar composition and significant
molecule size and we all knew about that reaction potential. I too am
curious that this was found this early, as allergy must be first evoked
during exposure and then become a problem-often awaiting the clinical
use for repeated exposure in large numbers to occur (i.e. streptokinase,
Trasylol-aprotinin).
P Kempen, MD, PhD
Posted by: "Miller, Sanford" sanford.miller@nyumc.org sanfordmmiller

Fri Aug 1, 2008 4:18 pm (PDT) 
*If* it makes it. Sugammadex is a big, complex molecule, which may be
capable of producing hypersensitivity all by itself, independently of
how it's packaged. If so, they've got their work cut out for them to try
to avoid the problem.

Sanford M. Miller, MD
sanford.miller@ nyumc.org

From: Rangraj Setlur
Sent: Fri 8/1/2008 12:01 PM
To: anesthideas; ccm
Subject: [ai] suggamadex just got rejected

strange. generally reports of hypersensitivity come out in Phase IV.
they must have been pretty common to show up in phase II/III. The other
thing is that I hadnt realised how high the stakes were. Apparently they
were hoping to recoup the lost profits from cholesterol drugs gone
generic, which seems a bit optimisitc to me considering that neostigmine
/glyco isnt that bad a solution. Expect to see a lot of scaremongering
and really heavy marketing about inadequate reversal when it finally
makes it.
rangraj

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