August 02, 2010
Afluria labeling updated to include fever and febrile seizure riskThe Prescribing Information for Afluria (trivalent, inactivated, "split virus" influenza vaccine [Types A and B], from CSL Biotherapies) has been updated to inform healthcare professionals of an increased incidence of fever and febrile seizure among young children in Australia, mainly those <5years of age. Available data suggest that the increased rates of fever and febrile seizure are only associated with the Southern Hemisphere formulation of Afluria. Data regarding the safety of other influenza vaccines for children used in the Southern Hemisphere do not suggest an increased rate of fever or febrile seizure.
The FDA is requiring CSL to conduct a study of Afluria in children to obtain additional information regarding the febrile events that were seen in the Southern Hemisphere. CSL will not be supplying the U.S. with the 0.25mL single-dose, prefilled syringes, which are used in very young children. The 0.5mL single-dose, prefilled syringes and 5mL multi-dose vials will be distributed.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220764.htm.