Tamiflu should be saved for special cases, CDC warns

Currently, only two anti-virals are known to be effective against H1N1 pandemic swine flu: Tamiflu (oseltamivir) and Relenza (zanamivir). If not used sparingly, these too could become ineffective, the CDC has warned.

Both drugs can be used to prevent viral infection under the right circumstances, though the protocol currently recommended by the CDC is to use these drugs in this manner only to protect pregnant women, people undergoing chemotherapy, and similar groups who are known to be at higher risk of death from swine flu.

Recently, the doctor at a camp in North Carolina decided to immunize 600 campers by using Tamiflu. The result: two girls caught swine flu anyway, and tests showed that their strain had developed Tamiflu resistance.

Tamiflu is approved by the FDA for “treatment of uncomplicated acute (mild) illness due to influenza infections in patients 1 year and older who have been symptomatic for no more than 2 days.” The drug is also approved for prevention of influenza in patients 1 year of age and older. On August 4, 2009, the FDA commisioner released an Emergency Use Authorization (EUA) for Tamiflu because of the Public Health Emergency that was declared in the wake of the H1N1 (swine flu) epidemic.

That EUA enabled use of Tamiflu to treat and prevent influenza in patients less than 1 year of age. The EUA also allowed for use of Tamiflu at later time points (that is, in patients symptomatic for more than 2 days) and in patients sick enough to require hospitalization (severe illness).

Those seeking more information on the EUA and the current regulations surrounding the use of Tamiflu can find it on the CDC website.

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One Response to “Tamiflu should be saved for special cases, CDC warns”

  1. William Klawonn Says:
    September 13th, 2009 at 8:01 am

    There is one and only one antivitral that has been specifically developed for IV administration, and may be very useful for hospitalized patients with severe syptoms who (i) may be unable to inhale Relenza and (ii) have a Tamiflu resistant virus or are unable to get – or keep down – an adeqaute load of Tamiflu through oral adminstration.
    That IV antiviral is peramivir, which is close to – but has not received – final FDA approval. It has substantial safey and efficacy data from its Phase I and Phase II clinical trials, and is likely to be approved in Jpan and Korea in the next six months. The FDA has been working on an emergency use authorization (EUA) for the crtically ill (ICU patients) for about 5-6 months, but has not yet issued that authorization. And critically ill people have died even though they might well have been helped by this intravenous antiviral.

    About 3 weeks ago the President’s Science advisors issued a report that supported the issuance of the EUA. I should note that permaivir could be used on an individual basis if the doctor applies for an EIND, but that process delays by a couple of days the moment peramivir may be adinistered, time the critically ill often do not have.

    Issue the EUA already allowing the immediate use of IV peramivir in the critically ill.

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