SILVER SPRING, Md -- October 26, 2009 -- In response to a request from the US Centers for Disease Control and Prevention, the US Food and Drug Administration has issued an emergency use authorisation (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and paediatric patients with confirmed or suspected 2009 A (H1N1) influenza infection who are admitted to a hospital.
Specifically, IV peramivir is authorised only for hospitalised adult and paediatric patients for whom therapy with an IV drug is clinically appropriate, based on 1 or more of the following reasons:
1. the patient is not responding to either oral or inhaled antiviral therapy, or
2. when drug delivery by a route other than an IV route -- eg, enteral or inhaled -- is not expected to be dependable or feasible;
3. for adults only, when the clinician judges IV therapy is appropriate due to other circumstances.
The FDA has reviewed the available scientific data and has concluded that the criteria for authorising 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 authorised for use under EUA for 2009 H1N1 infections.
The EUA authority allows the FDA, based on the evaluation of available data, to authorise 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 authorisation will end when the declaration of emergency is terminated or the authorisation is revoked by the agency.
As part of the conditions of the EUA, healthcare providers must report adverse events and all medication errors associated with peramivir to FDA's MedWatch program within 7 calendar days from the onset of the adverse event. Additionally, healthcare providers must conduct follow-up requested by FDA or CDC related to peramivir adverse event or medication error reports submitted to FDA.
The following adverse events must be reported to the FDA: death, neuropsychiatric events, renal adverse events, serious skin adverse events, hypersensitivity reactions, severe IV site or IV administration events, and other life-threatening events. More information on peramivir and on reporting adverse events is available from the FDA.
For more information on the EUA for peramivir, see http://www.cdc.gov/h1n1flu/eua/ or call 1-800-CDC-INFO (1-800-232-4636).
SOURCE: US Food and Drug Administration
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