FDA Warns of Valcyte Overdoses in Children

The US Food and Drug Administration (FDA) just issued a notification to healthcare professionals of new pediatric dosing recommendations for <"http://www.yourlawyer.com/practice_areas/defective_drugs">Valcyte (valganciclovir hydrochloride) oral tablets and oral solution.

Valganciclovir is an antiviral medication found to be effective in the prevention of cytomegalovirus (CMV) disease in children who range in age from four months to 16 years and who have undergone a kidney or heart transplant. CMV is a member of a group of herpes-type viruses that can cause disease in different parts of the body.

Patients with weakened immune systems, such as organ transplant patients, are particularly susceptible to CMV infection and must take medications such as Valcyte to prevent the disease.

FDA 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.

The side effects from Valcyte overdosing include abdominal pain, vomiting, diarrhea, tremor, or seizure. The FDA urges that patients/patient caretakers advise a healthcare professional immediately if patients experience signs and symptoms of valganciclovir overdose while taking Valcyte.

The FDA recommends that 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 FDA’s Drug Safety Communication at: http://www.fda.gov/Drugs/DrugSafety/ucm225727.htm

The FDA also advises practitioners to be aware of possible valganciclovir overdose in pediatric patients with low body weight, low body surface area, or below normal serum creatinine and to report adverse events involving Valcyte to MedWatch:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

• Download the form or call 1-800-332-1088 to request a reporting form.

• Complete and return the form to the address on the pre-addressed form, or submit the form by fax to 1-800-FDA-0178.

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