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WASHINGTON — Federal health regulators said Tuesday they are adding new labeling about the risks of infection to organ transplant drugs made by Roche, Novartis and other drugmakers.
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The Food and Drug Administration said it has received reports of dangerous viral infections in patients taking the drugs, which are typically used to avoid rejection following kidney transplant.
Drugs bearing the new labeling are: Roche's CellCept, Wyeth's Rapamune, Novartis' Myfortic, Sandimmune and Neoral.
The FDA said physicians should carefully monitor patients for signs of viral infection, which can sometimes lead to kidney failure.
The agency said it will continue to monitor reports of safety problems with the medications.
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