FDA authorizes emergency use of antiviral drug for 2009 H1N1 in certain cases

October 28, 11:51 AMNewark Healthy Trends ExaminerAl Saint Jacques

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The US Food and Drug Administration (FDA) has authorized the use of intravenous (IV) antiviral peramivir for certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenze infection, according to an FDA news release. This move was done in response to a request from the US Centers for Disease Control and Prevention (CDC).

Specifically, IV peramivir is authorized only for hospitalized adult and pediatric patients based on one or more of the following criteria:

• The patient is not responding to either oral or inhaled antiviral therapy,
• When drug delivery by a route other than an IV route -- eg, enteral (absorbed by the intestines) or inhaled -- is not expected to be dependable or feasible,
• For adults only, when the clinician judges that IV therapy is appropriate due to other circumstances.

Currently, there are no FDA-approved IV administered antiviral drugs for the treatment of influenza. Peramivir is the only IV administered influenza treatment now authorized for use under the emergency use authorization (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 uncleared medical products or unapproved or uncleared 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, according to the FDA.

For more information, go to the CDC Web site or call 1-800-CDC-INFO (1-800-232-4636).