NeLM news service
FDA Medwatch: Death following reconstitution of zanamivir (Relenza®) in liquid formulation and nebulisation

Source: FDA

Date published: 12/10/2009 17:00

Summary
by: Nicola Pocock

The FDA and GSK have notified healthcare professionals in the US of the death of a patient with influenza who received zanamivir (Relenza®) inhalation powder, which was solubilised and administered by mechanical ventilation.

 

The death, involving a pregnant woman outside of the US, was attributed to obstruction of the ventilator, believed to be due to stickiness caused by lactose (from the zanamivir inhalation powder) in the nebulising solution. 

 

GSK is aware that zanamivir is being dissolved in various solutions for the purpose of nebulisation for inhalation by patients with influenza who are unable to take oral medicines, or unable to inhale zanamivir using the Diskhaler.  The ‘Dear Healthcare Professional’ letter stresses that:

 

• Relenza® (zanamivir) Inhalation Powder is not intended to be reconstituted in any liquid formulation and is not recommended for use in any nebuliser or mechanical ventilator.
• Relenza® or zanamivir for nebulisation has not been approved by the FDA. The safety, effectiveness, and stability of zanamivir use by nebulisation have not been established.

 

Please see the links below for further details.

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