updated 12/10/2008 5:16:53 PM ET 2008-12-10T22:16:53

Deadlocked over the risks of long-acting asthma drugs, government health officials Wednesday asked outside advisers if four medications used by millions of patients should remain on the market.

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An unusually large panel of some 30 medical and scientific advisers will vote Thursday on whether the risks of the drugs_Advair, Foradil, Serevent and Symbicort_ outweigh the benefits. The Food and Drug Administration, whose own scientists are at odds, sought the advice in making a final decision.

Doctors who treat adults and children with asthma strongly urged the FDA not to ban the drugs. It would only trigger a dangerous surge in cases of uncontrolled asthma, they warned.

Some of the FDA advisers expressed frustration Wednesday over a lack of fresh clinical data on medications in use for a decade or longer. "I think this is an impossible task you are asking us to do," said Dr. Judith Kramer, who teaches medicine at Duke University Medical Center in Durham, N.C.

Overall, asthma deaths have declined as patients with moderate to severe bouts have increasingly turned to the long-acting medications in recent years. But evidence from clinical studies indicates at least some of the drugs carry a risk of serious respiratory problems, for reasons that are not well understood.

Experts from the FDA's s safety office are recommending that Serevent and Foradil no longer be used for treating asthma, and that Advair and Symbicort not be used for treating children 17 and younger. But the FDA office that oversees respiratory drugs says most patients benefit from the medications, and the risks can be addressed through warnings and educational materials for patients and doctors.

The medications already carry strong government warnings.

"We don't have evidence," said Dr. David Graham of the FDA safety office. "It's all based on presumptions. We assume a drug is safe. But when you test it, it's like the emperor has no clothes."

22 million in U.S. have asthma
Dr. Badrul Chowdhury of the respiratory drugs office said a ban would be an "extreme" reaction.

"Patients, health care providers and society have accepted serious adverse reactions, and even death, in a small number of patients for symptom control in a large number of patients," he said. "The safety risk can be managed."

In recent years, millions of asthma patients have started using the long-acting drugs to help them breathe more normally, allowing for nights of uninterrupted sleep or workouts at the gym.

But in rare cases, the drugs can increase the risk of serious asthma complications, the kinds that send patients to the emergency room gasping for air.

About 22 million people in the United States suffer from asthma, which claims nearly 3,600 lives. Children account for nearly one out of every three patients.

The companies that make the medications say they are safe, and that at least some of the medical evidence that has raised questions is of poor quality. Doctors who treat asthma are worried the drugs could be withdrawn.

"We would lose a medicine that patients find helpful," said Dr. Paul Greenberger of Northwestern University in Chicago, president-elect of the American Academy of Allergy, Asthma & Immunology. "We would be going backward, and the consequences of that would be more untoward effects of asthma. That's a major deal, because asthma hospitalizations continue to be too high."

The American Academy of Pediatrics is also urging the FDA to leave the drugs on the market.

The four drugs contain a kind of long-acting medication known as a LABA, for long-acting beta agonists. The drug relaxes tight muscles around narrowed airways. Medical guidelines for treating moderate to severe asthma recommend use of a LABA together with a steroid, which treats inflammation deep inside the airways.

Foradil and Serevent are LABA-only products. Advair and Symbicort combine a LABA and a steroid in one inhaler that patients use every 12 hours. Asthma patients must also carry a "rescue" inhaler to deal with the sudden onset of symptoms.

Masking symptoms?
Some experts believe that using a LABA drug alone can mask developing symptoms, and unexpectedly get patients in trouble. That's why medical guidelines call for LABA medications to be used along with a steroid.

In preparation for the meeting, the FDA analyzed findings from 110 clinical trials involving nearly 61,000 patients, comparing patients who took a medication containing a LABA with those who used a steroid alone to control their asthma. Experts looked for deaths, hospitalizations and cases in which a patient had to have a breathing tube inserted.

The analysis found 20 deaths from asthma complications, of which 16 were in patients taking a LABA-only drug, Serevent.

Advair, made by GlaxoSmithKline, did not appear to have a higher rate of serious complications when compared with treatment on steroids only. Foradil, Serevent and Symbicort all had higher rates of problems, but the increase was statistically significant only in the case of Serevent.

Several million asthma patients take the medications, with children accounting for about 10 percent, according to the FDA. Glaxo said nearly 4 million patients are taking Advair, which dominates the market.

Serevent is also made by Glaxo. Symbicort is made by AstraZeneca, and Foradil by Novartis.

Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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