Safety Alerts & Recalls

What does this mean?

The dosing recommendations for Valcyte in children have changed. If you are 16 years or younger and take Valcyte, or if you care for a child who takes Valcyte please follow up with your doctor and review any concerns you may have about Valcyte. The side effects of Valcyte overdosing include abdominal pain, vomiting, diarrhea, tremor or seizure. If you think you or your child is experiencing these side effects, please contact your doctor or seek medical attention right away.

FDA Announces New Pediatric Dosing Guidelines for Valcyte

The U.S. Food and Drug Administration (FDA) has announced new pediatric dosing recommendations for Valcyte (valganciclovir hydrochloride) oral tablets and oral solution. This change is being made to prevent potential valganciclovir overdosing in children with low body weight, small body size, and below normal kidney function.

Valganciclovir is sold under the brand name Valcyte. Valgancyclovir is an antiviral medication that can be effective for the prevention of cytomegalovirus (CMV) disease in children 4 months to 16 years of age who have undergone a kidney or heart transplant. Cytomegalovirus is a member of a group of herpes-type viruses that can cause disease in different parts of the body.

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Source: FDA
Publication Date: 2010-09-16
Last Updated: 2010-09-16

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