FDA panel says asthma drugs should stay on market but must carry warnings

Jul 14 2005

The U.S. Food and Drug Administration (FDA) advisory panel has declared that three asthma drugs are safe enough to stay on the market, after concerns that in rare cases they raise the risk of severe asthma.

Asthma drugs Serevent and Advair by Glaxo already come with "black box" warnings after one study showed Serevent patients had a higher, although small, risk of life-threatening asthma attacks and deaths.

Now the FDA are saying that the Novartis' drug Foradil, which is in the same category of drugs, should also carry a similar warning.

Panel member Dr. Steven Gay, medical director of critical care medicine at the University of Michigan Health System, says until proven otherwise, it has to considered that Foradil may act in the the same way.

Drug company Novartis says Foradil behaves differently than the Glaxo drugs and may be safer, they are however prepared to work with the FDA to 'finalize appropriate language'.

The FDA generally follows the recommendations of its advisory panels.

Asthma is a chronic lung disease that afflicts about 15 million Americans, nearly 5 million of them children, and it can cause episodes of wheezing, coughing and breathing difficulty. Severe asthma attacks can kill.

The three drugs Serevent, Advair and Foradil are inhaled drugs known as long-acting beta agonists that patients take daily to relax bronchial muscles and prevent asthma attacks.

According to panel members, the drugs' benefits in controlling asthma symptoms and improving lung function, outweigh the small possibility of a life-threatening asthma attack.

In a Glaxo study which is detailed on the drug labels, there were 13 deaths among about 13,000 patients treated for 28 weeks with Serevent, compared with three deaths among about 13,000 people given a placebo.

FDA reviewers say that Foradil was also found to trigger severe asthma attacks when given at a higher dose than the FDA approved.

But a further study done after approval was granted, was too small to draw conclusions about the safety concern.