Tamiflu causing death and neurological problems in kids

[Guest guest]

I know this is slightly off topic and that many of you probably do

not take flu drugs. However, since we are all very health conscious

and probably have family members who take flu drugs, I thought I'd

pass this on.

 

The following article was forwarded to me and recently appeared on

. It talks about how the FDA is evaluating whether a warning

lable should be added to Flu drugs. 25 people of the under age of

21 have died from Tamiflu, and many childre have suffered

neurological problems. As can be expected, a manufacturer of

another flu drug insists that neurological problems are a by-product

of the flu itself and not necessarily related to taking flu

medication. . .hmmmmm. . .

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FDA Wants Warnings on Flu Drugs for Kids

Friday November 23, 2:10 pm ET

By Matthew Perrone, AP Business Writer

 

 

FDA Wants Added Label Warnings About Bizarre Behavior in Kids That

Get 2 Widely Used Flu Drugs

 

WASHINGTON (AP) -- Government health regulators recommended adding

label precautions about neurological problems seen in children who

have taken flu drugs made by Roche and GlaxoSmithKline.

The Food and Drug Administration on Friday released its safety

review of Roche's Tamiflu and Glaxo's Relenza. FDA's panel of

outside experts will consider the government's proposed labeling at

its meeting Tuesday. FDA is not required to follow the advice of its

outside experts, though it usually does.

 

FDA began reviewing Tamiflu's safety in 2005 after receiving reports

of children experiencing neurological problems, including

hallucinations and convulsions.

 

Twenty-five patients under age 21 have died while taking the drug,

most of them in Japan. Five deaths resulted from children " falling

from windows or balconies or running into traffic. "

 

Over 48 million patients, including 21 million children, have taken

Tamiflu since it was approved in 1999. The drug, which comes in

capsule and liquid form, had sales of $2.4 billion last year.

 

There have been no child deaths connected with Relenza, but

regulators said children taking the drug have shown similar

neurological problems.

 

The label for British drug maker Glaxo's Relenza does not list any

neurological problems. A company spokesman said Friday no signficant

behavioral issues have been recorded in clinical studies or patient

safety reports. Sales of the drug last year were roughly $187

million.

 

While FDA said the reports of dangerous side effects could result

from an unusual strain of flu or a rare genetic reaction to the

drugs, the agency wants language about the possible side effects

added to labeling for physicians who prescribe Tamiflu and Relenza.

 

Tamiflu's current label lists the potential for self-injury and

delirium, but does not mention that these behaviors could result in

death. The FDA's proposed label would include that information.

 

In a statement Friday, Roche suggested it would consider changing

the label.

 

" If the FDA concludes that it is valuable to place additional

details on the label with regard to specific adverse event reports,

then Roche is open to that consideration, " the statement from

Roche, which is headquartered in Basel, Switzerland, said.

 

However, the company also stressed there is no concrete evidence

connecting its drug to the reported problems. It also pointed out

that many children with flu experience neurological problems, even

when they aren't taking medication.