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Trouble with Generic Tacrolimus

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Q. My daughter was put on generic Prograf (tacrolimus) as one of her immunosuppressants after a liver/kidney transplant. On tacrolimus, the levels of the drug in her body fluctuated widely, leading to one mild and one moderate liver rejection episode.

When she was hospitalized as a result of these episodes, they would administer brand name Prograf and levels of the drug in her body would increase dramatically.

She switched to brand name Prograf at home, even though it costs more. Levels of the drug in her body stabilized and she has had no more rejections.

A. Your story is extremely alarming. Tacrolimus is a lifeline for transplant recipients. We have passed your comment to the FDA. Anyone else who has experienced a generic drug problem can report it on our website (PeoplesPharmacy.com).

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4 Comments

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My husband was hospitalized for acute kidney transplant rejection in Feb 2010. In the hospital the doctor was very concerned when told that he had switched a few months earlier to the generic form of tacrolimus. He had previously been on Prograf for years with no rejection problems. The doctor said that they had at least 2 other patients who were treated for rejection after switching to the generic. We couldn't believe it, having switched after asking the nephrologist if it was OK to do so.

Unfortunately my husband's transplant couldn't be saved. He is currently back on dialysis waiting for another kidney transplant.

I too had problems with a generic substitute. Treating a DVT with warfarin, my INR/PT bounced around like a rubber ball (1.0 -9.7 with the same diet). Changing to Coumadin, my levels stabilized and remained steady for more than a year during my treatment.

I am so very sorry that your husband lost his transplant kidney. It's hard to believe how much we (Transplant pt.) go through, switching to generics and then on top of that!!! They switch us to other generics as though it doesn't really matter, I could tell horror stories of what I've gone through. I pray you will get another Kidney and that you won't be switched around with your meds. God Bless You and your husband, being on dialysis is rough once you've had the freedom of transplant.

I have been on Prograf for 6 years for my kidney transplant and I doing fine. Now my insurance will not pay for Prograff and I will start on Tracrolimus_Generic Prograff.I tried it about 2 years ago and my creatine went up-THEN WENT DOWN WHEN I WENT BACK ON PROGRAF!

I am worried I may lose my kidney DUE TO POOR INSURANCE. SAD WORLD! I will keep you posted.

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