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Top Asthma Drugs Get Stronger Warning

Increased Risk Of Death Associated With Key Ingredient

Mar 6, 2006 | KTLA News

The asthma medication Advair and Serevent will now carry the strongest warnings the FDA can require of prescription drugs.

The "black-box" warnings on both drugs caution that key ingredient salmeterol may increase the risk of asthma-related death.

The revised warning cautions that Advair should be used only by patients when other asthma drugs, such as low- to medium-dose inhaled corticosteroids, don't work or if their asthma is severe enough to merit use of two medications.

As for Serevent, it should only be used as an additional medication when the low- to medium-dose inhaled corticosteroids aren't sufficient or, again, if the asthma is serious enough to merit use of two drugs.

In a statement, drug maker GlaxoSmithKline said it was pleased to reach an agreement with the FDA on the label changes to its two drugs.

A third asthma drug, Foradil, manufactured by Novartis, remains in talks with the FDA and could receive a similar black box warning.

In making the ruling, the FDA cites a large U.S. study that found that more people using the asthma drugs died from their asthma compared with those taking dummy medication. The number of asthma deaths in the study was small, however: just 13 out of 13,176 patients.

The drugs assist with long-term control and prevention of asthma symptoms such as wheezing and shortness of breath by relaxing muscles around the airways in the lungs.

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