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The 1976 swine influenza vaccine was associated with an elevated risk of Guillain-Barré syndrome (GBS). Evidence for a causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated (1). If GBS has occurred within 6 weeks of previous influenza vaccination, the decision to give Fluzone, Fluzone High-Dose or Fluzone Intradermal should be based on careful consideration of the potential benefits and risks.
The prefilled syringe tip caps of Fluzone and Fluzone High-Dose may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.
Preventing and Managing Allergic Reactions
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
If Fluzone, Fluzone High-Dose, or Fluzone Intradermal are administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained.
Limitations of Vaccine Effectiveness
Vaccination with Fluzone, Fluzone High-Dose, or Fluzone Intradermal may not protect all recipients.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Fluzone, Fluzone High-Dose, and Fluzone Intradermal have not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
Use In Specific Populations
Fluzone and Fluzone High-Dose
Pregnancy Category C: Animal reproduction studies have not been conducted with Fluzone or Fluzone High-Dose. It is also not known whether Fluzone or Fluzone High-Dose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluzone or Fluzone High-Dose should be given to a pregnant woman only if clearly needed.
Pregnancy Category B: A developmental and reproductive toxicity study has been performed in female rabbits at a dose approximately 20 times the human dose (on a mg/kg basis) and has revealed no evidence of impaired female fertility or harm to the fetus due to Fluzone Intradermal. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Fluzone Intradermal should be used during pregnancy only if clearly needed.
Healthcare providers are encouraged to register women who receive Fluzone Intradermal during pregnancy in Sanofi Pasteur Inc.'s vaccination pregnancy registry by calling 1-800-822-2463.
It is not known whether Fluzone or Fluzone Intradermal is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fluzone or Fluzone Intradermal is administered to a nursing woman.
Safety and effectiveness of Fluzone in children below the age of 6 months have not been established. Safety and immunogenicity of Fluzone was evaluated in children 6 months through 8 years of age. [See ADVERSE REACTIONS and Clinical Studies.]
Safety and effectiveness of Fluzone High-Dose in persons < 65 years of age have not been established.
Safety and effectiveness of Fluzone Intradermal in persons < 18 years of age have not been established. In a clinical trial, 97 infants and toddlers 6 months through 35 months of age and 160 children 3 years through 8 years of age were enrolled to receive two injections of Fluzone Intradermal. Infants and children in a control group received two injections of Fluzone. Fluzone Intradermal was associated with increased local reactogenicity relative to Fluzone. The size of the study was not adequate to reliably evaluate serious adverse events or the immune response elicited by Fluzone Intradermal relative to Fluzone.
In two observational studies of Fluzone in 118 adults 19 through 59 years of age and 123 adults 61 through 86 years of age, the immune responses were lower in the older adults. [See Clinical Studies.]
Safety and effectiveness of Fluzone Intradermal in persons 65 years of age and older have not been established.
Last reviewed on RxList: 1/11/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Fluzone Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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