fda, glaxo warn of death due to anti-flu medic

FDA, Glaxo warn of death due to anti-flu medication
by Ayurdhi Dhar - October 10, 2009 Washington, October 10 -- Administration of Glaxo'z anti-flu drug Relenza leads to the death of a woman, prompting the FDA and Glaxo to issue warning to doctors.

According to GlaxoSmithKline, at least one death has occurred due to the wrong administration of their anti-flu drug, Relenza. Doctors all over the nation have been notified about the incident.

A letter was mailed to the doctors, informing them that the reason for the casualty was administration of the drug in liquid form. The Food and Drug Administration (FDA) does not approve of liquid administration of Relenza either. The patient had taken the drug through a mechanical ventilator.

The reason for the death
They also said that the death occurred outside the nation, and the victim was a pregnant woman who had been taking the medication through a ventilator for more than three days.

The obstruction, resulting from the build-up of lactose that causes stickiness, of the ventilator was the cause of the death. Lactose is a side product of the Relenza formulation.

"There is a risk that the lactose sugar in this formulation can obstruct proper functioning of mechanical ventilator equipment," Glaxo said in the letter.

How safe is the drug?
The letter was posted online on the FDA website on Friday. Glaxo mentioned that they knew of incidents in which the FDA-approved packing of the drug was removed, and the drug given in a soluble form for patients who could not take it in its original powder form.

“The safety, effectiveness, and stability of zanamivir (Relenza) use by nebulization have not been established,” the FDA warned.

The company has stated that Relenza "is not intended to be reconstituted in any liquid formulation and is not recommended for use in any nebulizer
or mechanical ventilator".

The drug Relenza
Relenza is a neuraminidase inhibitor, that is, an anti-viral drug, used for the treatment of influenza by blocking the function of neuraminidase protein. This restricts the virus from reproducing.

It is effective only if used within two days after the onset of symptoms.

The drug is not used for children below 7 years of age, and is effective only when inhaled. The side effects may include diarrhea, sinusitis, and nausea.

In April, the FDA had approved the use of Relenza and Tamiflu to cure the symptoms of swine flu, which is spreading rapidly throughout the nation, causing panic.

With the flu season setting in, the government has stocked up the anti-flu medication in millions.
http://www.themedguru.com/20091010/newsfeature/fda-glaxo-warn-death-due-anti-flu-medication-86129453.html

So when is Glaxo going to trial other delivery methods?? Seems there is demand.............