December 23, 2012
FDA Approves Tamiflu For Use In Children Over Two Weeks Old
redOrbit Staff & Wire Reports - Your Universe Online
An antiviral medication that can chemically slow the spread of influenza virus between the body's cells, has been approved by the US Food and Drug Administration (FDA) for use in infants as young as 14 days old, the agency announced on Friday.
According to Reuters, the agency declared the prescription drug Tamiflu, which is also known as oseltamivir phosphate, cannot be used to prevent flu infection in that age group, but it can be used as a treatment for children at least two weeks of age who have shown flu-like symptoms for no more than 48 hours.
Tamiflu is currently approved for use in both treating and preventing influenza for adults and children at least 12 months of age, the news agency added. It was approved in 1999, is distributed in the US by Roche subsidiary Genentech, and has been found to help lessen both the length and severity of the illness.
The FDA said children under the age of one must be calculated on a case-by-case basis, based on the weight of each individual patient, Jennifer Warner of WebMD Health News reports.
Those patients should receive three milligrams of Tamiflu per kilogram of weight twice a day for a period of five days, which will require a smaller dose dispenser than is currently packaged with the medication, she added.
"Pharmacists must provide the proper dispenser when filling a prescription so parents can measure and administer the correct dose to their children," Dr. Edward Cox, Director of the Office of Antimicrobial Products in the FDA´s Center for Drug Evaluation and Research, said in a statement. "Parents and pediatricians must make sure children receive only the amount of Tamiflu appropriate for their weight."
The decision to expand the use of oseltamivir phosphate was based on the "extrapolation of data from previous study results in adults and older children, and additional supporting safety and pharmacokinetic studies" that were sponsored by Roche and the National Institutes of Health (NIH), the FDA said.
"Almost all of the 135 pediatric patients enrolled in the two safety studies had confirmed flu. Results from these studies showed the safety profile in children younger than 1 year was consistent with the established safety profile of adults and older children," the agency said.
"The most common side effects reported with Tamiflu use in this age group include vomiting and diarrhea," they added. "Although not seen in the new studies, rare cases of severe rash, skin reactions, hallucinations, delirium, and abnormal behavior have been reported."