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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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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.

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