Patient Dies While Taking Relenza for Influenza, FDA Tells Docs
The Food and Drug Administration is warning healthcare professionals about the recent death of a pregnant woman who died after being administered a form of the influenza drug Relenza by an unapproved method.
The woman, who lived outside the United States, was given Relenza Inhalation Powder that was made soluble and delivered via mechanical ventilation, a process that is called nebulization and not recommended for administering Relenza in powdered form, the FDA said.
Relenza, also known chemically as zanamivir, is made by GlaxoSmithKline and 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.
However, British researchers later said the use of Relenza and Tamiflu to treat H1N1 in children appears to have few benefits and substantial risks to young children younger than 12.
The FDA sent an urgent warning letter to healthcare professionals on October 8, notifying them of the patient death and warning about the risks of administering powdered Relenza in a fine mist.
Improper Administration of Relenza Linked to Patient Death
Glaxo has heard reports of its powdered form of Relenza being removed from its packaging, dissolving it in water, and converting it into a fine mist, a process called nebulization, officials said. Doctors may be modifying the composition of the drug in order to give it to patients who cannot take oral medications or inhale the drug. However, nebulization is not recommended for administering Relenza Inhalation Powder, the FDA said.
“The safety, effectiveness, and stability of zanamivir (Relenza) use by nebulization have not been established,” the FDA warned.
Relenza Inhalation Powder is a combination of zanamivir and a lactose drug carrier. When subjected to nebulization, lactose sugar in the product can prevent mechanical ventilator equipment from working properly, the FDA cautioned.
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, causing her death, according to a report from her treating physician, the FDA said.
The Food and Drug Administration is warning healthcare professionals about the recent death of a pregnant woman who died after being administered a form of the influenza drug Relenza by an unapproved method.
The woman, who lived outside the United States, was given Relenza Inhalation Powder that was made soluble and delivered via mechanical ventilation, a process that is called nebulization and not recommended for administering Relenza in powdered form, the FDA said.
Relenza, also known chemically as zanamivir, is made by GlaxoSmithKline and 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.
However, British researchers later said the use of Relenza and Tamiflu to treat H1N1 in children appears to have few benefits and substantial risks to young children younger than 12.
The FDA sent an urgent warning letter to healthcare professionals on October 8, notifying them of the patient death and warning about the risks of administering powdered Relenza in a fine mist.
Improper Administration of Relenza Linked to Patient Death
Glaxo has heard reports of its powdered form of Relenza being removed from its packaging, dissolving it in water, and converting it into a fine mist, a process called nebulization, officials said. Doctors may be modifying the composition of the drug in order to give it to patients who cannot take oral medications or inhale the drug. However, nebulization is not recommended for administering Relenza Inhalation Powder, the FDA said.
“The safety, effectiveness, and stability of zanamivir (Relenza) use by nebulization have not been established,” the FDA warned.
Relenza Inhalation Powder is a combination of zanamivir and a lactose drug carrier. When subjected to nebulization, lactose sugar in the product can prevent mechanical ventilator equipment from working properly, the FDA cautioned.
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, causing her death, according to a report from her treating physician, the FDA said.
