FDA Warns of Possible Valcyte Children Overdoses

Federal drug regulators say that the current dosing instructions for the antiviral drug Valcyte can cause overdosing in children who have received organ transplants.  

The FDA issued a notice to healthcare professionals last week that they are changing the label on Valycte oral tablets and oral solution to prevent pediatric overdosing. The FDA said it was most concerned about children under the age of 16 with low body weight, low body surface area or very low serum creatinine who have received heart or kidney transplants. The agency did not say how many children, if any, have suffered a Valcyte overdose. 

Valcyte (valganciclovir) is an antiviral medication by Roche approved in 2001 for the prevention of cytomegalovirus (CMV) in people who have recently had an organ transplant, who are at increased risk of acquiring the virus. It is also approved by the FDA to treat CMV retinitis in adults who have been diagnosed with acquired immunodeficiency syndrome (AIDS). CMV can cause pneumonia and colitis in people with weakened immune systems, and transplant recipients often take immunosuppressors to prevent their bodies from rejecting the new organs. 

The label changes include a specific dosing formula for children that is based on the body surface area and creatinine clearance of children between the ages of 4 months and 16 years old. The changes also place a maximum of 900 mg on pediatric doses, regardless of the dose calculated by using the formula. 

The FDA recommended that healthcare professionals use the new dosing directions on the Valcyte label. The agency recommended that patients, or parents of patients, taking the drug talk to their healthcare professional about any concerns. Patients and their caretakers should also be aware of signs of a Valcyte overdose, including: 

• Abdominal pain
• Vomiting
• Diarrhea
• Tremors
• Seizures