November 4, 2009 Treating H1N1: FDA authorizes use of unapproved drug Play video

NECN: Latoyia Edwards - Boston, Mass.) - Imagine being hospitalized with the H1N1 virus but not allowed to take the only government approved medicines to treat the illness.

It's a frightening obstacle for certain patients suffering with the swine flu.

Dr. Martin Hirsch is an infectious disease physician at Mass General Hospital. He says these very sick swine flu patients are not able to take a nasal mist or oral medication and that's the only the way the standard H1N1 treatments Tamiflu and Relenza are given.

The Food and Drug Adminstration is taking a bold step: for the first time ever it's giving emergency authorization to use an unapproved drug, Peramivir.

The makers of Peramivir market it as a beneficial intravenous treatment for swine flu patients who cannot endure a nasal or oral medication.

Dr. Hirsch says the limited clinical trials on Peramivir should not concern patients.

The makers of the Peramivir say the unapproved drug is effective for uncomplicated influenza in certain child and adult patients.

The FDA acknowledges that only 1900 people were clinically tested with Peramivir before its release to the public. The most common side effects reported were diarrhrea, nausea and vomiting -- similar side effects to other treatments like Tamiflu and Relenza.