Asthma Drug- Triggers Attacks?

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Misty L. Trepke

http://www..com

 

Does Asthma Drug Trigger Attacks

http://www.cbsnews.com/stories/2003/12/17/eveningnews/main589058.shtm

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WASHINGTON, Dec. 17, 2003

 

 

Jim and Star Chavez didn't think twice when their doctor prescribed

Advair for their son Ethan.

 

Inhaled daily, Advair was supposed to prevent his occasional mild

asthma attacks. Instead, as CBS News Correspondent Sharyl Attkisson

reports, shortly after he started using Advair, Ethan collapsed.

 

" He was totally lifeless, " says Jim Chavez. " His eyes were rolled

back in his head, and it was really terrifying. "

 

" I shook him, and I kept on shaking him and kept on yelling his

name, 'Ethan, Ethan, wake up, wake up,' and he wouldn't respond at

all, " says Star Chavez.

 

They didn't know it then, but asthma patients taking the same

medicine in a study were dying in unexpected numbers.

 

Drugmaker GlaxoSmithKline led a study of Salmeterol, the medicine in

Advair and another Glaxo asthma product, Serevent. Designed to

relieve asthma, it seemed to trigger fatal attacks in some. Three

times more patients taking the medicine died of asthma than those

not taking it.

 

A safety monitoring board took one look at the deaths and shut down

Glaxo's study. The FDA recently forced Glaxo to disclose the small

but significant risk of death in a black box warning on its medicine

and in ads: " Rare but serious asthma episodes and asthma related

fatalities occurred. "

 

In the study, Glaxo found deaths among blacks were the highest,

though white deaths were also elevated. Glaxo then sent out a

carefully worded message that led some to believe white patients

need not worry: " These risks may be greater in African-Americans. "

 

Yet CBS News has learned a study ten years ago of only white

patients also found an increase in asthma deaths. Glaxo dismissed

the deaths back then as " probably due to the disease rather than the

treatment. "

 

Most people who use Advair have no serious problems, and the FDA

says benefits outweigh risks. And despite the new warnings, sales

have increased, approaching $2 billion a year.

 

And that black box warning ordered for Advair four months ago still

isn't on the product. The FDA says Glaxo negotiated when it will be

but won't tell CBS News the date.

 

Ethan has fully recovered from his trauma, and the whole family is

breathing easier without the asthma remedy that may have been worse

than the disease.

 

© MMIII, CBS Broadcasting Inc. .