FDA Warns Against Use of Zanamivir With Nebulizer

Emma Hitt, PhD


October 10, 2009

October 10, 2009 — The US Food and Drug Administration (FDA) and GlaxoSmithKline are reporting the death of a person with influenza after receiving zanamivir inhalation powder (Relenza) that had been dissolved and administered with a nebulizer.

Zanamivir is intended for use only with the Diskhaler device provided with the drug.

The manufacturer has become aware that the formulation is being dissolved in various solutions for the purpose of nebulizing zanamivir for inhalation by patients unable to take oral medications or use the Diskhaler.

According to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program, 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," it notes.

In a Dear Healthcare Professional Letter, GlaxoSmithKline states that the death attributed to nebulized zanamivir inhalation powder occurred outside the United States. The patient was a pregnant woman on mechanical ventilation who received the nebulized solution for 3 days. Death was attributed to obstruction of the ventilator.

More information is available on the FDA's MedWatch Web site.

Adverse events related to the incorrect administration of zanamivir 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 http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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