Concern over asthma drugs

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

Now the Food and Drug Administration is investigating whether the medications, in rare cases, can increase the risk of serious asthma complications, the kinds that send patients to the emergency room gasping for air.

At a two-day meeting, independent medical advisers will hear the scientific evidence and make recommendations on whether the drugs should continue to be used to treat asthma. At issue are four inhaler medications: Advair, Foradil, Serevent and Symbicord.

Within the FDA, opinions appear to be divided. The safety office is recommending that Foradil and Serevent no longer be used for asthma, and that none of the drugs be used by children 17 and under. But the head of the FDA office that oversees respiratory medications has written that banning the drugs would be "an extreme approach," and could backfire by leading to more cases of uncontrolled asthma.

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

The four drugs contain a kind of long-acting medication known as a LABA. 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 Symbicord 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.

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.

How the study was done
The FDA analysed 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, hospitalisations 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, a widely used medication made by GlaxoSmithKline, did not appear to have a higher rate of serious complications when compared with treatment on steroids only. Foradil, Serevent and Symbicord all had higher rates of problems, but the increase was statistically significant only in the case of Serevent.

There has been a significant increase in the number of people who have asthma amongst all races in South Africa. Over the past 25 years a 25 to 200 times rise in hospital admissions for asthma have been recorded in hospitals in Durban and Soweto.– (Sapa/Health24, December 2008)

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