H1N1: Peramivir Never Tested On Pregnant Women, FDA Now Allows

According to the Emergency Use Authorization of Peramivir IV Fact Sheet for Health Care Providers the following statistics are enlightening: --Only 1,891 clinical trials patients in the US were given any form of the drug --Out of 1,891 patients tested, NONE were children, pregnant women or nursing m...

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Bibliographic Details
Published inMcClatchy - Tribune Business News
Main Authors Burke-Galloway, Linda, M.D.
Format Newsletter
LanguageEnglish
Published Washington Tribune Content Agency LLC 04.11.2009
Subjects
Drug dosages
Health services
Human subjects
Patient safety
Patients
Pneumonia
Pregnancy
Swine flu
Womens health
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Summary:According to the Emergency Use Authorization of Peramivir IV Fact Sheet for Health Care Providers the following statistics are enlightening: --Only 1,891 clinical trials patients in the US were given any form of the drug --Out of 1,891 patients tested, NONE were children, pregnant women or nursing mothers --Out of the 1,891 clinical trial patients, only 478 received a "single-dose" regimen similar to what might be given in a hospital setting --Out of 1,891 patients, only 33 patients received a 600 mg dose for five days or greater It is not surprising that the drug cannot be deemed "safe" with such a small sample of patients.