關鍵詞： FDA Oseltamivir 羅氏藥業(yè)

2012年12月24日訊 /生物谷BIOON/ --美國FDA同意將Oseltamivir的適用范圍擴大到兩周以上的嬰兒,。當這些嬰兒表現出流感癥狀,，并且癥狀發(fā)現時間不超過兩天時，一聲可以酌情給其使用該種藥物,。

根據規(guī)定,，醫(yī)生在給一歲以上的嬰兒用藥時，必須嚴格根據嬰兒的體重來選擇用藥種類和劑量,。此次FDA決定擴大Oseltamivir的適用范圍時也規(guī)定，嬰兒接受Oseltamivir的劑量應控制在3 mg/kg,，一天兩次之內,。

Oseltamivir是由羅氏藥業(yè)研發(fā)并在1999年投入使用的藥物，該藥最早針對表現出流感癥狀不超過兩天的成年人,。（生物谷Bioon.com）

詳細英文報道：

The US Food and Drug Administration (FDA) today expanded the approved use of Oseltamivir ( Tamiflu, Genentech) 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 flu infection in this population. In addition, the safety and efficacy of Oseltamivir to treat flu 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," Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said 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 Centers for Disease Control and Prevention (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, Oseltamivir's manufacturer.

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.

Last month, the British Medical Journalalleged that Roche is deliberately hiding clinical trial data about the efficacy of Oseltamivir in patients with influenza and that it concealed neurologic and psychiatric adverse events associated with the drug.

In a media statement, Roche denied withholding clinical data and said it has made "full clinical study data available to health authorities around the world."

Tamiflu is distributed in the United States by South San Francisco-based Genentech, a member of the Roche Group.