Unapproved IV Medication Peramivir Given Emergency Use Authorization
for Treatment of Severe H1N1 Swine Flu Symptoms
photo by Guido Alvarez
On October 23rd, the Food and Drug Administration (FDA) announced an emergency use authorization (EUA) for use of the unapproved "investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients" with "confirmed or suspected" severe H1N1 swine flu symptoms when hospitalized.
When is IV Peramivir Authorized for H1N1 Swine Flu Symptoms?
The FDA has only approved use of this antiviral drug that is still under investigation for general approval under certain conditions:
- When the patient isn't responding to treatment with inhaled or oral medications
- When other treatment options besides intravenous delivery is expected to not be possible or dependable
- When a doctor decides IV therapy is "appropriate due to other circumstances" (for adult patients only)
Why Has Peramivir Been Given Emergency Use Authorization?
The FDA approved the request from the Centers for Disease Control and Prevention (CDC) to grant the EUA primarily because there is no approved intravenously administered antiviral medication. After "reviewing the available scientific data", the FDA decided that the potential benefits outweighed the potential risks to approve it for specific emergency situations dealing with severe H1N1 swine flu cases.
Although still unapproved, peramivir is in phase 3 clinical testing; commonly reported side effects of the drug have been diarrhea, nausea, vomiting, and neutropenia – meaning an abnormally low count I the blood of neutrophils, an important type of white blood cell, which greatly increases the risk of infections.
What Other 2009 H1N1 Swine Flu Emergency Use Authorizations Have Been Granted?
In addition to the unapproved drug peramivir, the FDA has issued EUAs for the two antiviral medications Tamiflu and Relenza, certain N95 respirators, rRT-PCR Swine Flu Panel diagnostic tests, and rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) diagnostic tests.
The two antiviral drugs, though previously approved by the FDA, were granted EUAs for certain aspects of distribution and use in treating H1N1 virus infections.
The EUA for the respirators concerned recommendation for use for the general public to help reduce the spread of the virus.
The two tests were not previously approved by the FDA, so the EUA was issued allowing them to be legally distributed and used.
What Does All This Mean?
It seems that this has been issued as a treatment of last resort, for when all other options have failed severely ill patients with H1N1 swine flu symptoms.
Still, much of the wording is somewhat disturbing; "confirmed or suspected" swine flu symptoms perhaps most so.
UPDATE: H1N1 Swine Flu pandemic officially declared national emergency - President Obama declared H1N1 a national emergency on October 24th.
For more information on H1N1 Swine Flu, see:
- Swine flu symptoms and treatment, for information about what the symptoms are and some ideas on how to deal with them
- Do I have H1N1 Swine Flu symptoms? New website may help answer, for a look at the symptoms and a website that may help determine if symptoms mean swine flu, and how likely they are severe
- What to do if you have H1N1 Swine Flu symptoms, for more in-depth advice on dealing with swine flu symptoms once you have it
- E.R.s flooded by H1N1 swine flu fears - when should medical care be sought?, which looks at how and why emergency rooms are being strained unnecessarily by H1N1 swine flu
- Have H1N1 Swine Flu Symptoms? Beware false internet treatment promises - FDA warns consumers to be cautious about fraudulent health claims
For more on natural antivirals and ways to prevent and treat Swine Flu symptoms, be sure to read:
- Natural Ways to Prevent Swine Flu
- Natural Treatment for H1N1 Swine Flu Symptoms
- Natural ways to boost immune system health, for a broad look at natural ways to increase immunity
- Top Ten Overall Immune System Booster Foods, looking more specifically at immunity builders in the diet
- Natural Antiviral Alternatives for an overview of foods, herbs, and essential oils that have natural antiviral properties
For a touch of humor, be sure to check out these great t-shits and other products about the Swine Flu Panic.
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