Health: U.S. Experts Mull Flu Drugs, Abnormal Behavior Link

[Guest guest]

U.S. Experts Mull Flu Drugs, Abnormal Behavior Link

 

Tue Nov 27, 2007 1:38pm EST

 

By Kim Dixon

http://www.reuters.com/article/healthNews/idUSN2747283820071127?feedType=nl & feed\

Name=ushealth200

 

GAITHERSBURG, Maryland (Reuters) - The safety of influenza drugs is

under scrutiny as advisers to the U.S. Food and Drug Administration on

Tuesday analyzed abnormal psychiatric behavior seen in some patients,

especially children.

 

Medical experts are reviewing cases of patients taking Roche Holding

AG's Tamiflu and GlaxoSmithKline Plc's Relenza experiencing

hallucinations, delirium and other abnormal behavior. In the case of

Tamiflu, several cases resulted in erratic behavior, including jumping

from buildings, resulting in death.

 

It's the third time health officials are publicly discussing flu drug

safety, originally prompted by reports two years ago of a dozen

deaths, including suicide, of children in Japan who had been taking

Tamiflu.

 

Japan in March warned against prescribing Tamiflu to those ages 10 to

19 when more than 100 people, mostly young, showed signs of strange

behavior after taking the drug. It also broadened its probe to other

flu drugs, Relenza and amantadine, after additional reports of

abnormal behavior.

 

FDA staffers are recommending a stronger label warning for Tamiflu to

note patient deaths and suggest close monitoring children for

behavioral changes. For Relenza, addition of a warning about

hallucinations and delirium is recommended.

 

Although there is still no evidence of a direct link, the contribution

of the drugs cannot be ruled out, FDA safety reviewer Dr. Adrienne

Rothstein told the panel, which will vote later on Tuesday on whether

to beef up labeling warnings.

 

Known generically as oseltamivir, Tamiflu is a pill, while Relenza,

generically known as zanamivir, is inhaled. Makers of both drugs have

stood by their safety, citing no direct evidence of cause and effect.

 

Two earlier FDA panels found no evidence of a direct link between

Tamiflu and the deaths, although the FDA did ultimately update

Tamiflu's label to add a caution urging close monitoring of patients

for abnormal behavior such as delirium or self- injury. Relenza's

label has no such warnings.

 

About 48 million people have taken Tamiflu worldwide, including 21

million children, since approval in 1999, according to Roche. Relenza

is much less widely used, by about 4 million people since its launch

in 1999.

 

The Japanese have adopted the drug much more broadly than the United

States, with a large majority of the worldwide use of Tamiflu

occurring in Japan.

 

Tamiflu had lackluster sales as a drug to prevent and treat seasonal

flu, but got a second life when it was the first drug to show real

efficacy in fighting a strain of bird flu that raised fears of a human

pandemic. Since then, Tamiflu has been stockpiled by governments

preparing for a potential flu pandemic.

 

The influenza virus is a major cause of death and illness in the

United States. Complications from the viral illness kills about 36,000

people a year in the country, a government expert told the panel.

Children and seniors are especially at risk.

 

Four drugs are approved for influenza, but generics amantadine and

rimantadine are no longer recommended for use as many strains of the

virus are resistant to them.

 

(Reporting by Kim Dixon; editing by Andre Grenon)

 

© Reuters 2006. All rights reserved.

[Guest guest]

And my family and friends think I'm an idiot, unkind and uncaring when I

refuse to give these things to myself OR (especially) my kids.

 

;-)

 

K

 

 

On 11/27/07, Butch Owen <butchowen wrote:

>

> .

>

>

>

 

 

 

--

Cheers!

Kathleen Petrides

The Woobey Queen

Http://www.woobeyworld.com

 

 

 

[Guest guest]

, " Kathleen Petrides " <WoobeyQueen

wrote:

>

> And my family and friends think I'm an idiot, unkind and uncaring when I

> refuse to give these things to myself OR (especially) my kids.

>

> ;-)

>

> K

>

>

And guess who used to be the CEO of Gilead, the patent holders of Tamiflu - none

other

than Donald Rumsfeld. From the article:

 

http://urbanlegends.about.com/library/bl_bird_flu.htm

 

CLAIM: " Do you know who markets Tamiflu? ROCHE LABORATORIES. "

TRUE. Roche is a pharmaceutical manufacturer based in Switzerland.

 

CLAIM: " Do you know who bought the patent for Tamiflu from ROCHE LABORATORIES in

1996? GILEAD SCIENCES INC. "

GARBLED. Gilead Sciences, Inc. discovered Tamiflu in the early 1990s and still

holds the

patent. Gilead licensed development and marketing rights to Roche in 1996.

 

CLAIM: " Do you know who was the then president of GILEAD SCIENCES INC. and

remains a

major shareholder? DONALD RUMSFELD, the present Secretary of Defence of the

USA. "

TRUE. According to Fortune magazine, Rumsfeld was Gilead's chairman from 1997 to

2001. It's unknown exactly how many shares he still owns in the company, but the

value

of his holdings is estimated at between $5 million and $25 million.

 

I don't take these things either and my family thinks I'm " off " from living 33

years in

California.