June 28, 2010
FDA Video: Warning Against Nebulizing Relenza Inhalation Powder
GlaxoSmithKline is alerting healthcare professionals about the dangers of reconstituting Relenza (zanamivir) Inhalation Powder into a liquid and using it in a nebulizer or mechanical ventilator. The powder, which is used in the treatment and prophylaxis of influenza, is only intended to be inhaled using a Diskhaler.
In a recent letter, the company notes that some practitioners have dissolved Relenza Inhalation Powder in various solutions. Using a mechanical ventilator, they then delivered the drug in nebulized form to patients who could not take oral influenza medications or could not inhale the drug using a Diskhaler.
The letter describes the death of a pregnant woman with influenza who was treated with Relenza Inhalation Powder that had been solubilized and administered by mechanical ventilation. The patient's death was attributed to obstruction of the ventilator, possibly from stickiness caused by lactose in the Relenza Inhalation Powder.
The letter reminds practitioners that the safety, effectiveness and stability of Relenza Inhalation Powder have not been established for nebulization, that this use has not been approved by the FDA, and that this drug should only be administered using the Diskhaler device that comes with it.