October 26, 2009 — The US Food and Drug Administration (FDA) has authorized emergency use of intravenous peramivir, an investigational antiviral drug, and as a result, the FDA is requiring mandatory adverse event reporting by healthcare providers.
"Given there are limited safety data on peramivir, mandatory reporting requirements are important to defining the safety profile of this unapproved drug," the FDA states in a Medwatch Alert.
According to the FDA, 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. They must also conduct follow-up requested by the FDA or the US Centers for Disease Control and Prevention (CDC) related to peramivir adverse event or medication error reports submitted to the FDA.
The emergency use authorization was issued late last week by the FDA in response to a request from the CDC. Peramivir is currently the only intravenous treatment authorized for emergency use in H1N1 influenza infection.
According to a fact sheet for healthcare providers, peramivir should be reserved for select patients, including those failing to respond to either oral or inhaled antiviral therapy. Peramivir should not be used for the treatment of seasonal influenza, nor is its use authorized for outpatients with acute uncomplicated 2009 H1N1 virus infection or for pre- or postexposure chemoprophylaxis (prevention) of influenza.
The drug may be used only in hospitalized adults and children who are not responding to oral or inhaled antiviral therapy or when drug administration by another route, such as enteral or inhaled, is not likely to work. In addition, the drug may be used in hospitalized adults only when a clinician determines it to be appropriate for other reasons.
Adverse events related to use of peramivir should be communicated to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
More information is available on the FDA's MedWatch Web site.
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Cite this: Mandatory Adverse Event Reporting Required for Peramivir - Medscape - Oct 26, 2009.