July 11, 2011
SAFETY ALERT: New Concentration of Tamiflu for Oral SuspensionThe FDA has notified healthcare professionals that labeling changes are being made for Roche's Tamiflu (oseltamivir phosphate) for Oral Suspension to reflect a new lower concentration from 12mg/mL to 6mg/mL. The lower concentration of Tamiflu is less likely to become frothy when shaken, which helps to ensure an accurate measurement. To reduce the possibility of prescribing errors and dosing confusion, a change has been made to the dosing table for Tamiflu to include a column for the volume (mL) based on the new 6mg/mL concentration. Additionally, the measurements of the oral dosing device have been changed from milligrams to milliliters. Container labels and carton packaging have been revised.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm262432.htm.