Does Asthma Drug Trigger Attacks?Dec 17, 2003 | www.cbsnews.com
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.