Relenza Patient Death a Reason for Concern

The recent death of a patient who died after being given the influenza drug Relenza by doctors using a method that is not recommended by the Food and Drug Administration raises questions about patient safety.

People who go to the doctor for medical treatment have a right to expect that their care will be administered properly, ethically, and in keeping with regulations for how drugs are used. When doctors take matters into their own hands and go against FDA regulations and the recommendations of drug companies for how medications should – and should not – be given to patients, they violate their patients’ trust and put lives at risk.

FDA Warns of Improper Administration of Relenza

The FDA issued a warning last week following the death of a pregnant woman who lived and was treated outside the United States. The FDA said the woman’s doctors gave her Relenza Inhalation Powder in a method that was not recommended.

Relenza, also known chemically as zanamivir, is a GlaxoSmithKline product approved for treating adults and children with certain strains of the influenza virus. In April, the Food and Drug Administration approved the emergency use of Relenza and another flu drug, Tamiflu, to fight the spread of the H1N1 flu virus.

In the case of the deceased patients, doctors took the powdered form of Relenza, dissolved it in water, and converted it into a fine mist, a process called nebulization. Changing the composition of the drug allows doctors to give Relenza to patients who are unable to take oral medications or inhale the drug, but nebulization is not recommended for administering Relenza Inhalation Powder, the FDA said.

Relenza Inhalation Powder is a combination of zanamivir and a lactose drug carrier. When the drug is dissolved and converted to a mist, lactose sugar in the product can prevent mechanical ventilator equipment from working properly, the FDA warned.

According to the FDA, the woman who died while being given nebulized Relenza Inhalation Powder had been receiving the drug for three days before the sticky lactose in the drug blocked the mechanical ventilator helping her breathe, leading to her death.

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