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<Home> <Newsletter> <Third Issue> <Antivirals for H1N1 Infection> <FDA Warns Against Use of Zanamivir With Nebulizer>
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
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