Riyadh October 11, 2009 – The U.S. Food and Drug Administration (FDA), the American counterpart to the Saudi Food and Drug Authority (SFDA) and GlaxoSmithKline (GSK) notified healthcare professionals of a report of the death of a patient with influenza who received Relenza (zanamivir) Inhalation Powder which was solubilized and administered by mechanical ventilation. Relenza (zanamivir) Inhalation Powder is not intended to be reconstituted in any liquid formulation and is not recommended for use in any nebulizer or mechanical ventilator.
GSK is aware that Relenza Inhalation Powder is being removed from its FDA-approved packaging and dissolved in various solutions for the purpose of nebulizing zanamivir for inhalation by patients with influenza who are unable to take oral medications or unable to inhale Relenza Inhalation Powder using the Diskhaler. 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.
Advice for healthcare professionals:
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. For further information
Report Adverse Drug Reaction to the SFDA:
The public and health care professionals are strongly encouraged to report adverse drug reaction to the National Pharmacovigilance Center (NPC) by filling the appropriate form on the following link: