The FDA and GlaxoSmithKline have notified healthcare professionals of a report of the death of a patient with influenza who received Relenza (zanamivir) inhalation powder which was solubilized and administered by mechanical ventilation. GlaxoSmithKline is aware that Relenza is being removed from its FDA-approved packaging and dissolved in various solutions for the purpose of nebulizing Relenza for inhalation for patients with influenza who are unable to take oral medications or inhale Relenza using the Diskhaler. Relenza has not been approved by the FDA to be reconstituted in any liquid formulation and is not recommended for use in any nebulizer or mechanical ventilator. The lactose sugar in the Relenza formulation can obstruct proper functioning of mechanical ventilator equipment. Relenza should only be used as directed in the Prescribing Information by using the Diskhaler device provided with the drug product.

Relenza is indicated for the treatment of uncomplicated acute illness due to influenza A and B virus in patients ≥7 years of age who have been symptomatic for no more than two days and for the prophylaxis of influenza in patients ≥5 years of age.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186081.htm.