ANTIVIRALS FOR H1N1 INFECTION
FDA Warns Against Use of Zanamivir With Nebulizer
Emma Hitt, PhD
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