FDA Recommends Restrictions on Some Asthma Drugs

Outside experts advising the Food and Drug Administration said Foradil and Serevent no longer should be used for asthma. But they said the benefits of the more widely used Advair and Symbicort clearly outweigh the risks.

Each contains an ingredient that relaxes muscles around stressed airways. But that may mask symptoms that can trigger life-threatening asthma attacks. Advair and Symbicort contain a second ingredient that reduces inflammation inside breathing passages and may help patients avoid such problems.

For all four drugs, the FDA’s drug safety experts had recommended restrictions, including not using them to treat asthmatic children. The agency’s respiratory specialists disagreed, saying the risks were manageable.

With its own experts deadlocked, the FDA called in an unusually large panel of nearly 30 outside advisers. The medical and scientific experts said Advair and Symbicort should continue to be used with all patients, including children. The FDA usually follows the recommendations of its outside advisers.

The panelists were unanimous in recommending that Advair (on a 27-0 vote) and Symbicort (on a 26-0 vote) continue to be used with adults. For Foradil, there were 18 “no” votes and nine “yes” votes – a “no” vote means the risks are greater than the benefits. For Serevent, “no” votes held a 17-10 edge.

It was a narrower vote on Advair and Symbicort on the question of whether they should be used for teenagers and children. An FDA analysis presented at the meeting said the risks were greater in children.

Advair is approved for ages 4 and older, and Symbicort for those at least 12. For the youngest age group, the vote on Advair was 13-11, with three abstentions. On Symbicort, the vote was 20-5, with two abstentions.

Patients should not stop any taking any of the medications without first consulting their doctors, said Dr. John Jenkins, head of the FDA’s new drugs office.

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

The four medications contain a kind of drug called a long-acting beta agonist, or LABA. It relaxes the muscles around stressed airways to help patients breathe.

But medical treatment guidelines say people with asthma should use a LABA together with a steroid to relieve inflammation within the airways. Advair and Symbicort combine both kinds of medicine in one inhaler. Foradil and Serevent are LABA-only medications.

In recent years, millions of asthma patients have turned to the long-acting drugs to help them breathe more normally, allowing adults to get nights of uninterrupted sleep, and kids, for instance, to join a soccer team. Advair dominates the market, with almost 4 million patients.

In rare cases, the drugs can increase the risk of serious asthma complications and send patients to the emergency room gasping for air.

Some experts believe that using a LABA alone can mask developing symptoms and unexpectedly get patients in trouble. That is why treatment guidelines call for LABA medications to be used with a steroid. Asthma patients also carry a “rescue” inhaler for emergencies.

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 had urged the FDA advisers not to ban LABAs.

“If this drug is removed from asthma treatment it would be a disaster,” said Dr. Stanley Szefler of National Jewish Health, a Denver health system with a national reputation for respiratory care. He spoke on behalf of the American Academy of Allergy, Asthma and Immunology. Other medical societies voiced similar sentiments.

Baltimore-area teacher Anne Dorsey came to the meeting with her son Julian, 13, who has severe asthma. The mother told the panel that Julian nearly died from an asthma attack in 2006. But he has done much better since then, after he started taking Advair.

“I’ve spent a lot of time in the hospital,” Julian said. “But when I took Advair, life got a whole lot easier.”

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.

Serevent is also made by Glaxo. Foradil is made by Novartis and Symbicort by AstraZeneca. That company disputed the FDA’s analysis of Symbicort, saying the agency only considered a small slice of available data.

Regardless of what the FDA ultimately decides, Serevent and Foradil are likely to remain on the market because they are also approved for other lung diseases.

Copyright 2008 The Associated Press.


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