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# Is Your Asthma Drug Doing You More Harm Than Good?
- URL: https://www.foodconsumer.org/asthma_drug_1109111030/
- Published: 2011-11-09T11:29:00.000Z
- Updated: 2026-09-22T16:12:10.000Z
- Description: Long-acting beta agonists such as Symbicort, Advair and Serevent warn on their labels of increased risk of death from asthma problems, with an estimated US toll of 4,000 a year. The piece says they can mask worsening asthma and lose effect the more they are used.
- Author: Food Consumer
- Tags: Drug, Health News, #vivvo-import

By Martha Rosenberg

Big Pharma has been accused of selling drugs that are so dangerous they cause death and drugs that cause the exact conditions they're supposed to treat. The popular asthma drugs Symbicort, Advair Diskus, Serevent Diskus, Dulera and Foradil do both and actually warn on their labels that they cause an increased "risk of death from asthma problems."

Big Pharma and the FDA have known for years that formoterol fumarate, found in Symbicort, Dulera and Foradil, and salmeterol, found in Advair Diskus and Serevent Diskus, can paradoxically cause asthma deaths, especially in children and African-Americans. In fact the FDA has heightened the warnings on the labels several times and convened several hearings about the drugs' safety and some doctors have called for their complete ban.

But the drugs, called long acting beta agonists, or LABAs, are so lucrative--Advair was the fourth best selling drug in the US last year, making almost $5 billion--they are marketed despite their estimated US death toll of 4,000 a year. That's equal to or even more than the number who die from asthma itself!

LABAs, whose aggressive marketing coincided with direct-to-consumer drug advertising, are billed as add-on drugs that treat asthma in a different way than traditional steroid asthma drugs. Traditional, inhaled corticosteriods like Flovent, Pulmicort, Asmanex and Qvar treat asthma's inflammation, while LABAs, prescribed as maintenance or "control" drugs, expand constricted airways and protect against bronchospasm.

But study after study show the "bronchoprotective" effects have a downside. They can "mask" asthma that is actually getting worse though people feel fine, and they can produce "desensitization" or "down regulation" also known as tolerance, in which the more you use them the less they work.

In fact, salmeterol, the drug in Advair and Serevent, is considered so unsafe, a huge trial called the Salmeterol Multi-center Asthma Research Trial, or SMART was terminated in 2003 after there were 16 deaths, 44 intubations and 369 hospitalizations on LABAs, mostly in African-Americans.

At FDA hearings after SMART, Pharma doctors tried to spin the results by saying the patients had been sicker to begin with, that they were too slow to seek medical care and that their self-reports of LABA use couldn't be trusted because patients lie. They also said (somewhat contradictorily) that LABAs don't mask worsening asthma because patients know if they are getting worse (not that they get worse!)--and the deaths can be explained by patients' DNA types. Whew.

LABA defenders even said the SMART results couldn't be trusted because the trial was stopped early.

Usually, the justification for unsafe drugs like LABAs is that their benefits outweigh their risk. But at FDA hearings three years later, David Graham, MD, an FDA official, said LABA "benefits, if any, seemed to be small compared to placebo." He also blew the whistle on the widespread Pharma myth that a decline in US asthma deaths over the last decade is due to LABAs.

"It is true that trend for reported asthma deaths has declined over time, " he said in the hearings. "But nobody has shown that the decline has anything to do with LABA use." Fifty percent of the decline "is due to the change in classification coding from IC-9 to ICD-10," said Graham, known for testifying before Congress about Vioxx dangers.

While the number of asthma deaths is down, the number of asthma sufferers is growing--and no one really knows why. Some cite more pollens in the air from global warming, an excess of allergy causing plug-in air fresheners and the "hygiene theory" that we have created such a germ and dirt free environment, our immune systems can't differentiate real threats from harmless pollens or dust.

Others cite burgeoning prescription drug use. Researchers at Henry Ford Hospital found children given antibiotics within their first six months of life were more likely to develop allergies. Data presented at the American Academy of Allergy, Asthma & Immunology suggest children whose mothers took prescription acid-blocking drugs like Nexium during pregnancy are more likely to suffer symptoms of asthma. And research in the American Journal of Respiratory and Critical Care Medicine found that Tylenol may be, "an important risk factor for the development and/or maintenance of asthma, rhinoconjunctivitis and eczema in adolescent children." Meanwhile, a 1999 European Union report speculates about the role of sex hormones and meat additives in asthma.

To prove that LABAs are safe and effective, Pharma not only points to falling US asthma deaths rates, it points to LABAs' inclusion in government asthma guidelines. Even though Pharma doctors wrote the government guidelines!

William W. Busse, MD, from the University of Wisconsin School of Medicine and Public Health, chaired the expert panel which developed the government's 2007 National Asthma Education and Prevention Program Guidelines--even though he is financially linked to GlaxoSmithKline, Merck, Novartis, Pfizer Genentech/Novartis, Schering and five other Pharma companies. According to the guidelines themselves.

No wonder federal guidelines extol the "established beneficial effects of LABA for the great majority of patients who require more therapy than low-dose ICS alone to control asthma," and call LABAs a "preferred option" that "improves lung function, decreases symptoms \[and\] reduces exacerbations!" Not that we have an opinion.

Why is a Pharma doctor writing federal disease treatment guidelines? And why, on top of 10 Pharma backers, does he have "research support from the NIH" which is our tax-dollars? Aren't enough tax dollars buying Medicare and Medicaid-reimbursed LABAs thanks to the "guidelines"? 

Since SMART and more reported deaths, the FDA has continued to hold hearings and tighten warnings. Currently, warnings say LABAs should only be used when inhaled corticosteriods don't control asthma, and for the shortest time possible and should not be used without corticosteriods or as a "rescue" medication.

Needless to say, if LABAs have to be used in addition to inhaled corticosteriods and in addition to rescue inhalers (like Proventil HFA, ProAir HFA, Ventolin HFA) what they are actually good for is not clear--even as Pharma sells a third, possibly surplus drug. No wonder Forbes magazine calls the LABA-containing Advair, "more a miracle of marketing than of science." Many also question whether the addition of an inhaled corticosteroid, which Symbicort, Dulera and Advair have, even makes them safer.

Of course, LABA promoters are furious about the warning that LABAs should not be used long term. "Suddenly stopping medication that is providing a protection for individuals--without good literature experience to back it up--is something we're very concerned about," said William Busse at an asthma conference. And when the FDA announced this year it will retest LABAs, Busse cowrote an angry letter to the New England Journal of Medicine. New trials are unnecessary he said and calling them "'safety' studies suggests that LABAs have some direct toxicity that causes death or leads to hospitalization."

Some people love LABAs and claim their asthma symptoms have gone away. But the longer they use them, the more likely they are to report Advair or Symbicort "poop-out" (like "Prozac poop-out") in which the drug stops working and they feel worse than before.

On the drug-rating web site askapatient.com, patients also report feeling "addicted" to the drugs and that their lung capacity is changing. "My lungs feel different than normal, like my lungs are feeling dried out and sticky if that is possible, all at the same time, reports one person about Symbicort. "It seems they are becoming lazy, like now they cannot miss a dose."

"When I sucked it in, it felt like I was collapsing my lungs," says an Advair user in Forbes. The man's doctor told him the drug "couldn't possibly be making him worse," but it was.

Twenty-five patients on Advair Diskus 100/50 also report racing and irregular heart beats, palpitations and the feeling of an imminent heart attack.

Coming: Part Two--Singulair and Xolair