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FDA Notified of Death from Inappropriate Use of Relenza


The seasonal and H1N1 flu continue to be in the news. Deaths from H1N1 flu is frequently reported. We have all been warned about the increased risk of H1N1 in pregnant women, our youth under 24 years of age, and those with chronic illnesses.

Now comes a warning on using Relenza (zanamivir) properly when treating the flu.

GlaxoSmithKline (GSK) and FDA have notified healthcare professionals of a report of the death of a patient with influenza who received Relenza (zanamivir) Inhalation Powder which was used inappropriately.

The flu drug Relenza was solubilized and administered by mechanical ventilation. Relenza Inhalation Powder is not intended to be reconstituted in any liquid formulation and is not recommended for use in any nebulizer or mechanical ventilator.

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The patient was a pregnant woman living outside the U.S., but GSK informed the FDA that it was aware that drug was being used this way as a treatment for influenza patients who are unable to take oral medications or who are "unable to inhale Relenza Inhalation Powder using the Diskhaler."

Relenza Inhalation Powder should only be used as directed in the prescribing information by using the Diskhaler device provided with the drug product.

Relenza Inhalation Powder is a mixture of zanamivir active drug substance and lactose drug carrier. This formulation is not designed or intended to be administered by nebulization. There is a risk that the lactose sugar in this formulation can obstruct proper functioning of mechanical ventilator equipment.

Relenza or zanamivir for nebulization have not been approved by the FDA. The safety, effectiveness, and stability of zanamivir use by nebulization have not been established.

Reference: FDA Safety Alert