The
U.S. Food and Drug Administration today expanded the approved use of
Tamiflu (oseltamivir) to treat children as young as 2 weeks old who have
shown symptoms of flu for no longer than two days. The drug is
not approved to prevent flu infection in this age population. In addition,
the safety and efficacy of Tamiflu to treat flu infection has not been
established in children younger than 2 weeks old.
JANUARY 11 UPDATE: CDC: U.S. Flu Death Rate Epidemic
Tamiflu was
approved in 1999 to treat adults infected with flu who have shown
symptoms for no longer than two days. It has since been approved to
treat flu in children ages 1 year and older who have shown symptoms of
flu for no longer than two days, and to prevent flu in adults and
children ages 1 year and older.
Although there is a fixed dosing
regimen for patients 1 year and older according to weight categories,
the FDA says that the dosing for children younger than 1 year must be calculated for each
patient based on their exact weight. These children should receive 3
milligrams per kilogram twice daily for five days. These smaller doses
will require a different dispenser than what is currently co-packaged
with Tamiflu.
“Pharmacists must provide the proper dispenser when
filling a prescription so parents can measure and administer the correct
dose to their children,” said Edward Cox, M.D., M.P.H, director of the
Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation
and Research. “Parents and pediatricians must make sure children
receive only the amount of Tamiflu appropriate for their weight.”
Tamiflu
is the only product approved to treat flu infection in children younger
than 1 year old, providing an important treatment option for a
vulnerable population. According to the Centers for Disease Control and
Prevention (CDC), children younger than 2 years are at higher risk for
developing complications from the flu, with the highest rates of
hospitalization in those less than 6 months of age.
The FDA
expanded the approved use of Tamiflu in children younger than 1 year
based on extrapolation of data from previous study results in adults and
older children, and additional supporting safety and pharmacokinetic
studies sponsored by both the National Institutes of Health and Roche
Group, Tamiflu’s manufacturer.
The FDA monitors drugs for side effects and
believes reporting side effects is important. Health care professionals
and patients should report any side effects associated with Tamiflu’s
use to FDA’s MedWatch program.
The FDA says that Tamiflu
is not a substitute for early, annual flu vaccination, as recommended
by the CDC’s Advisory Committee on Immunization Practices. CDC
recommends all persons aged 6 months and older receive an annual flu
vaccine.
Tamiflu is distributed in the United States by South San Francisco-based Genentech, a member of the Roche Group.
