Fluzone Flu Vaccine Subject of Seizure Reports in Children

<"http://www.yourlawyer.com/practice_areas/defective_drugs">Fluzone, a seasonal flu vaccine manufactured by Sanofi Pasteur, is being investigated for a possible link to febrile seizures in young children. According to a posting on the U.S. Food & Drug Administration’s (FDA) website, there has been an increase in the number of young children who have febrile seizures after being vaccinated with the Fluzone flu vaccine.

Fluzone is the only influenza vaccine recommended for use for the 2010-2011 flu season in infants and children 6-23 months of age. Fluzone is one of a number of trivalent influenza vaccines that the FDA has approved for the 2010 to 2011 influenza season.

According to the FDA, there has been an increase in reports of febrile seizures in children receiving Fluzone to the Vaccine Adverse Event Reporting System (VAERS), which the agency operates jointly with the Centers for Disease Control (CDC), Most of the cases have involved children younger than age 2 years. There has not been a similar increase in febrile seizures among children aged 2 years and older who have received a trivalent inactivated vaccine, nor among children receiving a live, attenuated vaccine (FluMist, the nasal spray vaccine).

In the cases reported, all children recovered and no lasting effects have been seen, the FDA said.

The FDA and CDC are conducting further analyses to investigate this preliminary finding in VAERS and will provide additional information as it becomes available. The FDA said it is also working closely with the manufacturer to obtain additional information and investigate the situation further.

Febrile means “relating to a fever” or an unusually high body temperature. In some children, having a fever can cause a seizure. Although febrile seizures can be frightening for the child’s caregivers, nearly all children who have a febrile seizure recover quickly and have no long term effects. Febrile seizures may occur with any common childhood illnesses that may cause fever, such as ear infections, colds, influenza and other viral infections, and they sometimes happen after vaccination.

The FDA posting also notes that recommendations for the use of flu vaccine in children have not changed. The CDC still recommends that all persons ages 6 months and older receive a flu vaccine each year.

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