The U.S. Food and Drug Administration (FDA), Friday gave the green signal to a flu drug, Tamiflu, for treating two-week old babies who display flu symptoms.
While announcing the expanded approval of the drug, FDA specified that the drug is yet to be approved for preventing flu infection among babies younger than 12 months.
It was in 1999 that FDA approved Tamiflu, manufactured by Swiss drugs company Roche to treat flu infections and to prevent flu in adults and children aged 12 months and above. The drug is still awaiting approval to treat flu infection among babies younger than two-week old.
According to FDA, infants younger than a year should be given a dosage of 3 milligrams per kilogram of weight twice daily for five days. A separate dispenser than the regular one that comes along with the Tamiflu drug pack should be used for measurement.
"Pharmacists must provide the proper dispenser when filling a prescription so parents can measure and administer the correct dose to their children," Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a news release. "Parents and pediatricians must make sure children receive only the amount of Tamiflu appropriate for their weight."
For giving the final nod, FDA reviewed previous studies that explored safety of the drug among adults and children above 12 months. Apart from that, National Institutes of Health and the Roche group experimented effectiveness of the drug on 135 pediatric patients and succeeded in proving the safety of the drug in infants.
However, researchers found the drug leading to some common side effects in infants like vomiting and diarrhea. According to FDA, the drug can sometimes also lead to severe rashes, skin reactions, hallucinations, delirium and abnormal behaviour.
