Prevent Swine Flu

The U.S. Food and Drug Administration has announced recently that in response to a request from the U.S. Centers for Disease Control (CDC) and Prevention, it has issued an emergency use authorization or EUA for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital. The CDC has developed an electronic request system that lets healthcare providers request peramivir for patients who have been admitted to their hospitals due to 2009 H1N1 influenza.

More explicitly, IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically suitable, based on one or more of the following reasons.  The first is if the patient is not responding to either oral or inhaled antiviral therapy, or when drug delivery by a route other than an intravenous route like enteral which is absorbed by the intestines or inhaled is not expected to be dependable or feasible.  The other is for adults only, when the health care professional deems IV therapy is appropriate due to other circumstances and t he FDA has reviewed the available scientific data and has concluded that the criteria for authorizing the emergency use of IV peramivir have been met.

There are no FDA-approved intravenously administered antivirals for the treatment of influenza. Peramivir is the only intravenously administered influenza treatment currently authorized for use under EUA for 2009 H1N1 infections. The EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or un-cleared medical products or unapproved or un-cleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met. The authorization will end when the declaration of emergency is terminated or the authorization is revoked by the agency.

It has been reported that by the end of July, up to 5.7 million Americans which is 140 times the reported number had H1N1 swine flu.  As many as 21,000 flu sufferers were hospitalized by July 23, according to CDC estimates. This suggests that the current number of H1N1 swine flu-related hospitalizations is a vast underestimate. The number is just under 22,000 from the end of August to the middle of October.

When reporting numbers of hospitalizations and deaths, CDC officials have always noted that the data is just a guide to the severity of the pandemic and not a precise tally.  We still don’t really know exactly how many millions of Americans have come down with H1N1 swine flu.  That question is still unanswered, but there’s been more than a fivefold increase in increasing flu-related hospitalizations and deaths since Aug. 30.

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