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| |  Zanamivir Dry Powder Should Not Be Delivered by Nebuliser, FDA Warns ROCKVILLE, Md -- October 12, 2009 -- The US Food and Drug Administration (FDA) and GlaxoSmithKline (GSK) are notifying healthcare professionals of a report of the death of a patient with influenza who received zanamivir (Relenza) Inhalation Powder which was solubilised and administered by mechanical ventilation. Zanamivir Inhalation Powder is not intended to be reconstituted in any liquid formulation and is not recommended for use in any nebuliser or mechanical ventilator. The safety, effectiveness, and stability of zanamivir use by nebulisation have not been established and have not been approved by the FDA. Zanamivir Inhalation Powder should only be used as directed in the prescribing information by using the Diskhaler device provided with the drug product. The death referenced above occurred outside the US and was of a pregnant woman on mechanical ventilation who received zanamivir solution made from dry powder product from zanamivir Rotadisks via nebuliser for 3 days. Death was attributed to obstruction of the ventilator. The reporting physician believed that the obstruction in the ventilator was due to stickiness caused by lactose (from the Inhalation Powder) in the nebulising solution. Although an investigational aqueous formulation for nebulizer delivery was briefly explored during the early development of zanamivir and may be mentioned in some descriptions or publications of those early-phase studies, that formulation did not use the lactose-based powder contained in the marketed product (Relenza).
SOURCE: US Food and Drug Administration
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