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FDA Says No Valcyte With Liver Transplant

Kate Traynor

The Food and Drug Administration (FDA), through its MedWatch safety and adverse-event reporting program, warned against the use of valganciclovir hydrochloride, or Valcyte, for the prevention of cytomegalovirus (CMV) disease in liver-transplant recipients who are at high risk for disease caused by the virus.

The warning was based on clinical trial findings of a higher frequency of overall and tissue-invasive CMV disease in patients given valganciclovir instead of ganciclovir. On the basis of the study findings, FDA declined to award a new indication for valganciclovir in liver-transplant recipients who are at high risk for CMV disease.

The agency did award the product an indication for the prevention of CMV disease in patients undergoing a kidney, kidney-pancreas, or heart transplant. Valganciclovir, a product of Roche Laboratories Inc., originally earned FDA marketing approval in 2001 for the treatment of CMV retinitis in patients with AIDS.

The revised labeling (PDF) for valgancyclovir is available from Roche.