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Robert
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Email Response from the FDA:
RE: DrugInfo Comment Form FDA/CDER Site
From: CDER DRUG INFO (DRUGINFO@fda.hhs.gov)
Sent: Tue 6/23/09 12:48 PM
"Thank you for writing the Division of Drug Information, in the FDA'sCenter for Drug Evaluation and Resear…
The CEO of Astellas Pharma US, Inc., makers of Prograf were sent a WARNING LETTER (NDA #50-708 and 50-709
Prograf (tacrolimus capsules and injection).
You can read in an FDA warning letter about the specific Nephrotoxicity effects of Prograf:
"...…
Avoid Prograf, it can slowly cause kidney failure. The effects are often very slow, subtle and can sneak up on you over a long period and this often confounds the specialists who are not aware that Prograf is the culprit in the slow decline of kidne…
Avoid Prograf, it can slowly cause kidney failure. The effects are very subtle, over long period and often confound the specialists. Suggust switching to the Cellcept/Rapamune combo protocol. I have more than five years experience with prograf and g…
Absolutely, Prograf is nephrotoxic.
Cellcept/Rapamune protocol is nephro-protective!
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Subject: Kidney failure after long-term use of Prograf (following Liver Transplant).
Patient's new kidney…
Subject: Kidney failure after long-term use of Prograf (following Liver Transplant).
Patient's new kidney also began to slowly fail/decline (initially after transplant, while still on Prograf). The new kidney immediately began to recover after stop…
Subject: Kidney failure after long-term use of Prograf (following Liver Transplant).
Patient's new kidney also began to slowly fail/decline (initially after transplant, while still on Prograf). The new kidney immediately began to recover after stop…
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Robert's Blog
Prograf - Avoid
Subject: Kidney failure after long-term use of Prograf (following Liver Transplant).
Patient's new kidney also began to slowly fail/decline (initially after transplant, while still on Prograf). The new kidney immediately began to recover after stopping the Prograf. Expert medical studies show that Prograf is toxic to the kidneys... Medical studies by experts at Albert Einstein Transplant Center support/promote the idea of stopping Prograf due to toxic effects on the kidney and using Cellcept (a… Continue
Patient's new kidney also began to slowly fail/decline (initially after transplant, while still on Prograf). The new kidney immediately began to recover after stopping the Prograf. Expert medical studies show that Prograf is toxic to the kidneys... Medical studies by experts at Albert Einstein Transplant Center support/promote the idea of stopping Prograf due to toxic effects on the kidney and using Cellcept (a… Continue
Posted on June 20, 2009 at 2:00pm — 1 Comment
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