Comments on: Tamiflu should be saved for special cases, CDC warns http://healthspectator.com/2009/09/11/tamiflu-should-be-saved-for-special-cases-cdc-warns/ Health News, Views & Analysis---Helping You Take Charge of Your Health Thu, 25 Feb 2010 00:02:57 +0000 hourly 1 http://wordpress.org/?v=3.2.1 By: William Klawonn http://healthspectator.com/2009/09/11/tamiflu-should-be-saved-for-special-cases-cdc-warns/#comment-784 William Klawonn Sun, 13 Sep 2009 12:01:40 +0000 http://healthspectator.com/?p=2525#comment-784 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. 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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