Mandatory Adverse Event Reporting Required for Peramivir (newswine flu anti-viral)

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http://www.medscape.com/viewarticle/711268?src=rssThe 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 not be used for the treatment of seasonal influenza. Its use is authorized only for outpatients with acute, uncomplicated 2009 H1N1 virus infection or for preexposure or postexposure chemoprophylaxis (prevention) of influenza.

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