A public warning about the life-threatening danger of a popular asthma drug — widely advertised on TV — is not being taken seriously enough by doctors or their patients, a top Tucson asthma specialist says.
The warning — issued in recent weeks by the U.S. Food and Drug Administration — centers on a class of drugs known as long-acting bronchodilators, which studies show actually can intensify asthma attacks in some patients, at times with fatal results.
Those drugs are known by the brand names Serevent, Foradil and Advair — the latter promoted almost constantly in prime-time TV ads aimed at the general public, an audience that has been plagued in recent decades by dramatically increased asthma rates.
In the Tucson area, about one of every 10 residents — 95,000 people — suffer from asthma, a chronic lung disease marked by episodes of difficulty breathing, which can be fatal. That makes Tucson one of the nation's top five "asthma hot spots," according to recent studies. Phoenix also is on that list.
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Arizona's warm, dry climate has attracted respiratory sufferers for generations, building a population genetically predisposed to asthma and other lung problems, experts have said. It is a problem intensified by our prolonged allergy season.
Doctors here estimate one-third of our asthmatics are taking these high-risk medicines, also known generically as long-acting beta agonists.
No one knows just why these drugs sometimes do exactly the opposite of what they're supposed to do — constrict airways, causing a severe asthma attack, instead of opening airways to prevent those attacks.
But recent, large studies in both the United States and the United Kingdom have shown that asthma patients taking the drugs suffered three to four times the rate of such attacks, and attack-related deaths as those not taking them.
Though the number of deaths was small, the FDA was alarmed enough to issue a strong public-health advisory in December about the risk, ordering drugmakers to strengthen "black box" warnings on their labels, and urging doctors to prescribe them only if other asthma drugs have failed to control attacks.
But that is not happening, leaving some patients at grave risk, said Dr. Fernando Martinez, director of the University of Arizona Respiratory Center, who is one of the nation's top experts in this disease.
"These drugs have long been used as a first-line treatment, and they're still being used that way," said Martinez, who last summer served on the FDA advisory committee that reviewed the alarming studies and recommended the strengthened warnings and limited use.
"I'm afraid it's going to take a long time for people, including doctors, to accept that this medicine can do the opposite of what is promised in these ads to the public," he said. "There are still people out there who think I'm exaggerating this risk.
"But the fact is, these were randomized, controlled scientific trials, so we know the deaths were in fact linked to these drugs," he said. "In a small minority of patients, these drugs have a bad result, and this cannot be disregarded."
Martinez voiced his concerns nationally in a recent editorial in the New England Journal of Medicine, saying the long-acting bronchodilators such as Advair "should not usually be needed," and should be prescribed only as a last resort.
"Doctors are so pressed for time these days, so they figure 'I'll give the whole treatment, so this patient won't have to come back,' " he said. "But that's not acceptable with these drugs. In fact, it can be dangerous."
Well aware of the warning, several Tucson asthma specialists said they are continuing to use the long-acting drugs as a standard treatment for many patients, and not as a last resort.
But they stress they're always used in combination with another asthma medication, an inhaled corticosteroid. The corticosteroid deals with the underlying inflammation that causes asthma, while the beta agonists help keep the airways relaxed, preventing an acute attack.
"I've been doing this for 30 years, and have had not one asthma death," said Dr. George Makol, a Tucson asthma and allergy physician.
"I've had thousands of patients on this kind of combination, and when used together, you see lung function start to recover. You see that with no other kinds of drugs.
"So, no, I'm not quite following the FDA guidelines. It's fair to say that."
Many more patients are at risk for asthma death because they are not being fully treated than are at risk from drugs such as Advair, Makol said.
But he's keeping an open mind on the issue, and is eager to attend a national allergy and asthma conference next month.
"What I hear there could change my mind," he said. "I know this is going to be a major discussion."
The Tucson mother of a child with severe asthma said his doctor has downplayed the warning about Advair, which her son began taking a few months ago.
"It was kind of casual, the way he talked about it. He said the risk didn't apply to everyone, and that the study results may have something to do with people not taking the drugs in the right way," said Charmaine Rice, whose son, Jashon, 6, has been hospitalized in intensive care four times in the last four years for severe asthma attacks.
"We did get a letter about the Advair warning, but the doctor basically said not to worry about it," she said.
Rice, who is black, was unaware that the risk of a bad reaction is somewhat higher for blacks on these drugs than for other ethnicities, possibly for genetic reasons.
But it does appear Jashon was prescribed Advair only after several other drugs failed to control his attacks, and he is being monitored closely.
His most recent attack, in August, kept him in intensive care and out of school for a week. He finally was put on Advair only after that, and now visits his doctor every three months.
"I really do think he is improving. He's had no episodes at all since then," Rice said. "He's a very active child. His asthma doesn't really stop him."
On StarNet: Find information about what causes asthma, treatments and medications at go.azstarnet.com/asthma
● Applies to a class of drugs known as long-acting bronchodilators, specifically Serevent, Foradil and Advair.
● Warns "these medicines may increase the chance of severe asthma episodes, and death when those episodes occur."
The FDA advises:
● Do not use these drugs as the first medicine to treat asthma. Add them only if other medicines do not control asthma.
● Do not stop using these drugs without first consulting your doctor.
● Do not use them to treat wheezing that is worsening. Call your doctor immediately if that happens while using them. Always use a short-acting bronchodilator (such as albuterol) to treat sudden wheezing.
