Emergency use authorization (EUA) issued for peramivir for H1N1 influenza infection

The FDA has notified healthcare professionals that it has issued an Emergency Use Authorization (EUA) for intravenous peramivir (from BioCryst Pharmaceuticals), an investigational antiviral drug, for use in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital. Intravenous peramivir is authorized only for hospitalized patients for whom therapy with an IV drug is clinically appropriate, based on one or more of the following:
  • The patient is not responding to either oral or inhaled antiviral therapy
  • When drug delivery by a route other than an intravenous route is not expected to be dependable or feasible
  • For adults only, when the clinician judges IV therapy is appropriate due to other circumstances
Safety data on peramivir is limited, thus as part of the conditions of the EUA, healthcare providers must report adverse events and all medication errors associated with peramivir to the 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.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187814.htm.