Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The death of a patient suffering from influenza who was treated with Relenza (zanamivir) Inhalation Powder in a manner not approved by the Food and Drug Administration (FDA), has spurred a notification from the drug maker to infectious disease health care professionals and hospital risk managers urging them not to use the medication in any form that is not approved by the FDA.

The incident occurred in the United States and involved a pregnant woman on mechanical ventilation. The patient received zanamivir solution made from dry powder product from Relenza Rotadisks via nebulizer for three days. 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 the Relenza Inhalation Powder in the nebulizing solution.

Relenza is made up of a mixture of zanamivir and lactose. Relenza Inhalation Powder should only be used as directed in the prescribing information by using the Diskhaler device provided with the drug. It is not intended for use with a nebulizer as there is a risk that lactose sugar in the formulation can obstruct proper functioning of mechanical ventilator equipment.

In the October 8, 2009 letter, GlaxoSmithKline (GSK) says it is aware that Relenza Inhalation Powder was being removed from its FDA-approved packaging and dissolved in various solutions for the purpose of nebulizing zanamivir for inhalation by patients with influenza who are unable to take oral medications or unable to inhale Relenza Inhalation Powder using the Diskhaler. The letter urged health care providers not to reconstitute the powder in any liquid formulation and not to use it in any nebulizer or mechanical ventilator as the safety, effectiveness and stability of zanamivir use by nebulization have not been established and is not approved for use by the FDA.

Patients with questions concerning Relenza should contact GSK’s Response Response Center at 1-8888-825-5249.

This entry was posted on Tuesday, October 13th, 2009 at 9:42 am and is filed under product liability. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.