Liquified Relenza Powder Implicated in Death
The Food & Drug Administration (FDA) and GlaxoSmithKline have issued a warning about the proper use of Relenza Inhalation Powder following th death of a patient who was administered liquified Relenza Inhalation Powder via mechanical ventilation.
According to the FDA, Glaxo is aware that Relenza is being removed from its FDA-approved packaging and dissolved in various solutions for the purpose of nebulizing the drug for inhalation by patients who are unable to take oral medications or unable to inhale Relenza using the provided Diskhaler. Relenza for nebulization has not been approved by the FDA. The safety, effectiveness, and stability of Relenza use by nebulization have not been established.
According to a “Dear Healthcare Provider” letter issued by Glaxo, there has been a report of an influenza patient who died after Relenza was solubilized and administered by mechanical ventilation. The death occurred outside the U.S. and was of a pregnant woman on mechanical ventilation who received Relenza solution via nebulizer for three days. The death was attributed to obstruction of the ventilator. The reporting physician believed that the obstruction in the ventilator was due to stickiness caused by lactose from Relenza in the nebulizing solution, the letter said.
Relenza Inhalation Powder is approved for treating adults and children with certain strains of the influenza virus. In April, the FDA approved the emergency use of Relenza and another flu drug, Tamiflu, to fight the spread of the H1N1 flu virus.
