Valcyte FDA Alerts
The FDA Alerts below may be specifically about Valcyte or relate to a group or class of drugs which include Valcyte.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for Valcyte
Valcyte (valganciclovir hydrochloride) Label Change: Possible overdose in pediatric patients
ISSUE: FDA is notifying healthcare professionals of new pediatric dosing recommendations for Valcyte (valganciclovir hydrochloride) oral tablets and oral solution. FDA has determined that adding an upper limit of 150 mL/min/1.73 m2 to the creatinine clearance calculated using the Schwartz formula for the determination of pediatric doses can help prevent the potential for Valcyte overdosing in children with low body weight, low body surface area, and below normal serum creatinine.
BACKGROUND: Valganciclovir 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.
RECOMMENDATION: If the calculated pediatric dose of Valcyte exceeds 900 mg, a dose of 900 mg should be administered to the child. The dosing calculation can be found in the Drug Safety Communication. Be aware of possible valganciclovir overdose in pediatric patients with low body weight, low body surface area, or below normal serum creatinine. Report adverse events involving Valcyte to MedWatch:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
[09/15/2010- Drug Safety Communication - FDA]
Valcyte (valganciclovir HCl tablets)FDA and Roche notified healthcare professionals of the findings of an active comparator study of Valcyte and ganciclovir in heart, liver, kidney, and kidney-pancreas transplant patients at high risk for CMV disease. Based on those findings: (1) Valcyte is indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk, (2) Valcyte is not indicated for use in liver transplant patients, and (3) The safety and efficacy of Valcyte for the prevention of CMV disease in other solid organ transplant patients, such as lung transplant patients, have not been established.
[September 30, 2003 Letter - Roche]
[September 2003 Revised label - Roche] PDF Format