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 (and Rapamune combo instead).

Additional Comments: In my opinion, Prograf should be taken off the market as soon as possible...as much better options are available (meds such as Cellcept and Rapamune that protect the kidney). I believe hundreds, if not thousands of other transplant patients have suffered untold harm due to this drug staying on the market. By 2003, the studies and experts became aware of the issues with Prograf, yet little has been done in the interim to resolve the issues. Even today, Walter Reed transplant lists Prograf high on their list of protocols, well above the Cellcept/Rapamune protocol. This is a travesty and needs to be corrected so that other patients do not continue to suffer from the use of the drug (Prograf) and the harmful effects on the kidney.

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Comment by Robert on June 23, 2009 at 9:53pm: 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 Research. According to the Prograf package insert, Prograf can causenephrotoxicity (kidney toxicity), particularly when used in high doses.Nephrotoxicity was reported in approximately 52% of kidneytransplantation patients and in 40% and 36% of liver transplantationpatients receiving Prograf in the U.S. and European randomized trials,respectively, and in 59% of heart transplantation patients in a Europeanrandomized trial. More overt nephrotoxicity is seen early aftertransplantation, characterized by increasing serum creatinine and adecrease in urine output. Patients with impaired kidney function shouldbe monitored closely as the dosage of Prograf may need to be reduced.In patients with persistent elevations of serum creatinine who areunresponsive to dosage adjustments, consideration should be given tochanging to another immunosuppressive therapy. Care should be taken inusing Prograf with other nephrotoxic drugs. In particular, to avoidexcess nephrotoxicity, Prograf should not be used simultaneously withcyclosporine. Prograf or cyclosporine should be discontinued at least24 hours prior to initiating the other. In the presence of elevatedPrograf or cyclosporine concentrations, dosing with the other drugusually should be further delayed. You may find information on Prograf and nephrotoxicity in the productlabeling, or package insert, under the WARNINGS section. The productlabeling is the most complete single source of information on the drug."