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Adverse effects of FK506 overdosage after liver transplantation

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  • Chemistry
  • Medicine
  • Pharmacology


{ ~I 5?' Adverse Effects of FK 506 Overdosage After Liver Transplantation M. Alessiani, U. Cillo, J.J. Fung, W. Irish, K. Abu-Elmagd, A. Jain, S. Takaya, D. Van Thiel, and T.E. Starzi PK 506 and cyclosporine (CyA) are not chemically related and have different cytosolic binding sites. 1.2 However. it was noted almost immediately after FK 506 was introduced clinically that its toxicity profile was sim- ilar to Cy A. 3-, The principal side effects of nephrotoxi- city,~ diabetogenicity,1·8 and neurotoxicity9.IO have been reponed individually. However. we win present here the full range of these and other adverse reactions together in the first 370 consecutive liver recipients who were entered into the Pittsburgh FK 506 study during 1989 and 1990. This case accrual was during a learning curve in which the daily induction doses were two or three times greater than those presently recommended. Consequently. a unique and unintended opportunity existed for overdose toxicology studies. METHODS Case Material The 370 consecutive adult patients received 417 liver transplants between August 1989 and December 1990. All patients were undergoing primary transplantation when they entered the study. Because older age was not a negative factor for candidacy. 76 (20.5%) of the 370 patients were 60 years or older. of whom many had been declined for treatment elsewhere. Mean age was 47.0 :: 12.7 years (range 15 to 75). The indications for liver transplanta- tion are summarized in Table I. Parencbyma! liver disease. to which postnecrotic and alcoholic cirrhosis were the largest con- tributors. accounted for 64.6% of the cases. Cholestatic diseases. for which the liver replacement operation tends to be technically easier. accounted for only 19.2% of the total. The urgency for transplantation for the majority of the candi· dates was high as defined by the United Network for Organ Sharing (UNOS) criteria that existed at the time (Table I): status 1. at home. functioning without nu

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