Relenza Death Linked to Improper UseOct 12, 2009 | Parker Waichman LLP
The improper use of Relenza Inhalation Powder has been associated with the death of a patient. According to an alert from the U.S. Food & Drug Administration (FDA), the death occurred after Relenza Inhalation Powder was converted to a liquid and administered via mechanical ventilation. Relenza is not intended to be reconstituted in any liquid formulation and is not recommended for use in any nebulizer or mechanical ventilator.
Relenza Inhalation Powder is made by GlaxoSmithKline and is approved for treating adults and children with certain strains of the influenza virus. Relenza is meant to be used with Glaxo’s Diskhaler device. In April, the FDA approved the emergency use of Relenza and another flu drug, Tamiflu, to fight the spread of the H1N1 flu virus.
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 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.
According to a report on Food Consumer, the FDA approved Relenza in July 1999, despite a negative recommendation from its own Anti-viral Drugs Advisory Committee. The committee was "underwhelmed" by the drug's performance and voted 13 to 4 to reject it. The FDA committee members found that Relenza was "no more effective than a placebo in treating common flu symptoms" and that it would "reduce by about one day a patients symptoms," Food Consumer said.
One year after its approval, Glaxo revised the labeling of Relenza to more clearly reflect a risk of serious respiratory adverse events, Food Consumer said.
In March 2008, Glaxo added new warnings to the "Warnings and Precautions" section of the Relenza package insert regarding neuropsychiatric events. In November 2007, an FDA advisory panel had recommended stronger warnings about psychiatric side effects be added to the labeling of both Tamiflu and Relenza. The recommendations where based on a review of nearly 600 psychiatric adverse event reports in Tamiflu patients, and another 115 reports among people taking Relenza.