CLINICAL CONTEXT
The US Food and Drug Administration (FDA) first approved oseltamivir in 1999 to treat adults infected with influenza who have had symptoms for not longer than 2 days. It was subsequently approved to treat influenza in children at least 1 year old with symptoms for no longer than 2 days and to prevent influenza in adults and children at least 1 year old.
Children younger than 2 years are at higher risk for the development of complications from influenza, according to the Centers for Disease Control and Prevention (CDC). Children younger than 6 months have the highest rates of influenza-related hospitalization.
STUDY SYNOPSIS AND PERSPECTIVE
The FDA expanded the approved use of oseltamivir (Tamiflu) to treat children as young as 2 weeks old who have shown symptoms of influenza for no longer than 2 days.
The drug is not approved to prevent influenza infection in this population. In addition, the safety and efficacy of oseltamivir to treat influenza infection have not been established in children younger than 2 weeks old.
Although there is a fixed-dosing regimen for patients aged 1 year and older according to weight categories, the dosing for children younger than 1 year must be calculated for each patient according to the child's exact weight, the FDA said in a press release. These children should receive 3 mg/kg twice daily for 5 days. These smaller doses will require a different dispenser than what is currently co-packaged with oseltamivir.
"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, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, in the press release. "Parents and pediatricians must make sure children receive only the amount of Tamiflu appropriate for their weight."
Oseltamivir was approved in 1999 to treat adults infected with influenza who have shown symptoms for no longer than 2 days. It is the only product approved to treat flu infection in children younger than 1 year. According to the CDC, children younger than 2 years are at higher risk of developing complications from the flu, with the highest rates of hospitalization in those younger than 6 months.
Oseltamivir is not a substitute for early, annual influenza vaccination, as recommended by the CDC's Advisory Committee on Immunization Practices, the FDA said. The CDC recommends that all persons aged 6 months and older receive an annual flu vaccine.
The FDA expanded the approved use of oseltamivir in children younger than 1 year on the basis of 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, the maker of oseltamivir.
The most common adverse effects reported with oseltamivir use in this age group include vomiting and diarrhea. Although not seen in the new studies, rare cases of severe rash, skin reactions, hallucinations, delirium, and abnormal behavior have been reported.
CLINICAL IMPLICATIONS
- The FDA has expanded the approved use of oseltamivir for treatment of influenza in children as young as 2 weeks old with symptoms for no longer than 2 days. It is not approved to prevent influenza in children younger than 1 year, nor is it intended as a substitute for early, annual influenza vaccination, as recommended by the CDC for all persons at least 6 months old. The safety and efficacy of oseltamivir to treat influenza infection have not been determined in children younger than 2 weeks.
- For children younger than 1 year, the oseltamivir dose must be calculated based on the child's exact weight (3 mg/kg twice daily for 5 days). These smaller doses will require that the pharmacist provide a dispenser different than the one that is currently packaged with oseltamivir.
- Among children younger than 1 year, the most common adverse effects associated with oseltamivir are vomiting and diarrhea. There have been rare reports of severe rash, skin reactions, hallucinations, delirium, and abnormal behavior, but not in the new studies underlying approval of the extended use of oseltamivir.
Info Taken from Medscape.com
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