Alerts
Zanamivir (Relenza) – Potentially Fatal if Nebulized
October 9, 2009
FDA received a report of a patient who died after receiving zanamivir (Relenza) inhalation powder that was solubilized and administered via mechanical ventilation. The manufacturer of zanamivir, GlaxoSmithKline, has no data regarding the safety, stability, or effectiveness of zanamivir when it is dissolved and administered via nebulization or mechanical ventilation. Zanamivir powder for inhalation is formulated with a lactose excipient. The lactose sugar could obstruct mechanical ventilator equipment. Limited data are available regarding nebulized zanamivir in early studies; however, the investigational product used in the studies was a different formulation and did not contain the lactose excipient.
Additional information is available at the following links:
- MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186081.htm - Dear Healthcare Provider Letter:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/UCM186224.pdf
Updated
October 9, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
