Anything that comes out of the mouth of any manufacturers
representative is considered by the FDA to be product labelling. So
I can understand their reservations about having reps talk to those
using the product for off-label purposes. Lynn
At 8:17 AM -0500 11/30/05, Schwaner, Sandra L *HS wrote:
I recently spoke with the Altepase rep, who said they had been
trying to get a study of hemodialysis patients involving blocking
with Altepase, but were turned down, as the group was too
heterogenous. They are currently looking at a study of hemophilia
patients with lines, who don't need ANY heparin in their system.
I'd love to see if we could convince them to evaluate this use of
Altepase in conjunction with antibiotic therapy for infected lines.
She said that there are many people out there coming up with new
ways to use altepase, and the company will only let her visit those
who use Altepase for catheter clearance of occlusions. They were
actually told to stop coming to see us in angio; because, although
we use altepase in that way, we also use TPA infusions to clear
clotted vessels, and do 4 hour infusions of TPA for tunneled lines
and ports, and the company was afraid it would be seen as condoning
off-label use of the drug.......
Sandy Schwaner RN
Angio/Interventional Radiology
University of Virginia
Charlottesville
________________________________
From: [EMAIL PROTECTED] on behalf of Donna J Gordon DJGORDON
Sent: Tue 11/29/2005 8:06 PM
To: Lynn Hadaway
Cc: Innes, Kim Bourn; Nicastro, Margaret; Stone, Gloria; Nancy
Costa; [EMAIL PROTECTED]; [EMAIL PROTECTED]; Kimberly Sutters
Subject: RE: question for group new subject
We have used altepase for catheter infections, especially on peds
patients. If a lot of blood is being drawn through the line, there
is the risk of fibrin buildup within the catheter lumen, regardless
of how carefully you flush. Using the altepase to "clean out" the
lumen eliminates the breeding ground for the bacteria...works well
Donna Gordon
--
Lynn Hadaway, M.Ed., RNC, CRNI
Lynn Hadaway Associates, Inc.
126 Main Street, PO Box 10
Milner, GA 30257
http://www.hadawayassociates.com
office 770-358-7861
