FDA Authorizes Emergency Use of IV Peramivir for Some H1N1 Patients

In response to a request from the Centers for Disease Control, the Food and Drug Administration will allow emergency use of the investigational antiviral intravenous drug peramivir in some hospitalized patients with 2009 H1N1 influenza infection.  The Emergency Use Authorization (EUA) is effective for both adults and children from birth to age 17.

There are currently no intravenous (IV) antiviral medicines approved for influenza. 

Peramivir is only allowed to be used in situations where an IV drug is determined to be necessary.

  • For both adults and children when the patient isn’t responding to inhaled or oral antiviral therapy.
  • When drug delivery by another route — via the intestinal tract or inhaled — is not expected to be dependable or feasible
  • For adults only, when the doctor determines that IV administration is appropriate for other reasons.

The FDA has developed a Fact Sheet for Patients and Parents/Caregivers about Peramivir and its use to treat 2009 H1N1 influenza.  They tell both patients and parents that they can decide whether or not to use the drug and can stop it at any time.

A perspective about the EUA and peramivir was  published in the New England Journal of Medicine on November 2, 2009.

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