Hoffman-La Roche: FDA expands Tamiflu usage for newborns and infants

The FDA, in a press release dated December 21, 2012, has expanded the approved usage of Tamiflu, the flu drug manufactured by Hoffman-La Roche pharmaceuticals, a global healthcare company based in Basil, Switzerland. The drug itself is manufactured by Roche Holding AG, and distributed in the U.S. by Genentech, a South San Francisco based company, a member of Roche Holdings Group.

Tamiflu was officially approved in 1999 to treat adults infected with flu who have shown symptoms for no longer than two days. It has since been approved for the treatment of flu symptoms in children ages one year and older presenting with flu symptoms for no longer than two days, and to prevent flu in adults and children ages one year and younger.

This new expansion and approved usages of Tamiflu, is for children as young as two weeks old who have shown symptoms of the flu for no longer than two days. However this drug is not approved to prevent flu infection for these new patients, as young as two weeks old and up to one year in age. Additionally the safety of Tamiflu to treat infection in children younger than two weeks old has not yet been established.

Tamiflu requires proper usage of a fixed dosing protocol, for all patients one year and older, according to their exact weight. This is especially important in children less than one year old, as overdosing may have extreme side effects. The new dosing recommendations for children from two weeks old to one-year-old will be even more exact and defined, requiring a different dispenser then the prepackaged measurement dispenser that currently comes with the prescription when purchased.

“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.”

As reported by the Centers for Disease Control and Prevention, CDC, children younger than two years of age are at a higher risk for developing complications from the flu, with the highest rates of hospitalization in those areas are for infants less than six months of age.

Tamiflu is currently the only FDA approved medicine to treat the flu infection in children younger than one year old, providing an important treatment option for the most vulnerable population.

The FDA expanded the approved use of Tamiflu in children younger than one year old 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 for Health NIH, and the Roche Group, Tamiflu’s manufacturer.

The FDA monitors drugs for side effects and believes reporting side effects is important. Healthcare professionals and patients should report any side effects associated with Tamiflu’s use to the FDA’s MedWatch program.

Tamiflu is not a substitute for early, annual flu vaccinations, as recommended by the CDC’s advisory committee on immunization practices. The CDC recommends all persons age 6 months and older receive an annual flu vaccine.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products to give off electronic radiation, and for regulating tobacco products.

Now that winter has officially arrived, it is definitely cold and flu season here in the United States. For more information about the flu, click here.

Article by Jim Donahue

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