Asthma drug risks outweight benefits

Risks of some asthma drugs greater than benefits, FDA told
Foradil, Serevent singled out
Last Updated: Thursday, December 11, 2008 | 5:16 PM ET Comments7Recommend22CBC News
Leading U.S. health officials said Thursday that the risks of some long-acting asthma drugs outweigh their benefits.

An unusually large panel of 27 medical and scientific advisers to the United States Food and Drug Administration — the country's chief food and drug regulator — called for restrictions to be placed on Serevent and Foradil. They said the health risks of taking the two drugs were greater than their benefits.

But the panel did not say the drugs should no longer remain on the market, saying instead that the drugs should be taken with an inhaled steroid to relieve inflammation in the airways.

Advair and Symbicort, two other drugs being reviewed, both contain a second ingredient that reduces inflammation, and the experts agreed that the benefits of those two drugs outweigh the risks.

Advair is the top-selling asthma drug in the U.S. Advair, Serevent and Foradil are licensed for sale in Canada.

FDA experts deadlocked
The FDA's own drug safety experts had recommended restrictions on all four drugs, including that none of them be used to treat asthmatic children. But the agency's respiratory specialists said the risks were manageable and no curbs were needed.

The agency brought in the panel of 27 outside advisers to break the deadlock.

The panel said Advair and Symbicort should continue to be used with all patients, including children. On Foradil, nine voted "yes" when asked if the benefits of taking the drugs outweighed its risks, while 18 said "no. When asked the same question in reference to Serevent, the vote was 10-17.

The FDA usually follows the recommendations of its outside advisers.

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

All four drugs under review contain a kind of long-acting medication known as a LABA — a long-acting beta agonist — that is responsible for reducing inflammation.

But some experts believe that using a LABA drug alone can mask developing symptoms, and unexpectedly get patients in trouble. Some medical guidelines call for LABA medications to be used along with a steroid to more effectively combat inflammation in the airways.

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

Doctors who treat people with asthma have pushed the FDA not to ban the drugs, saying it would only trigger a dangerous surge in cases of uncontrolled asthma.

Several million asthma patients take the medications, with children accounting for about 10 per cent of them, according to the FDA. GlaxoSmithKline, the makers of Advair, say nearly 4 million patients are taking the drug.

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

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