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BY OUR PHARMA CORRESPONDENT
15 July, 2005: Following the concerns of safety raised against the three popular asthma drugs, the U S government has asked a panel of experts to decide whether these medications to stay in the market.
Advair, Serevent and Foradil are the three drugs whose safety in preventing asthma attacks being called into question as these drugs``have been associated with severe asthma exacerbations."
Both Advair, Serevent made by GlaxoSmithKline, contain salmeterol as active ingredient. Foradil, made by Novartis and sold in the United States by Schering Plough has formoterol.
The drugs are different from the inhaled medicines used to treat attacks as the patients are to take them every day even if they are feeling well to keep their airways open.
Advair and Serevent already carry warnings about a study that showed a small but significant increase in deaths among people who added the drugs to their usual asthma treatment: 13 deaths in 13,176 patients who took the drugs, versus 3 in 13,179 who took placebos. Foradil was not part of the study and does not carry such a warning.
The advisory committee of 14 asthma experts who are expected to review the data on the drugs, listen to presentations from the manufacturers and others. Then they will vote on whether the products should be left as they are, relabeled or taken off the market altogether.
However, both the companies said they would present data showing that the drugs' benefits far outweighed their risks, and that they should be left on the market.
More than 21 million adults and 8 million children in the United States have asthma.
Advair, sold overseas as Seretide, was the third-best-selling drug in the world in 2004, with sales of more than $4.5 billion. In the past 12 months in the United States, 17.2 million Advair prescriptions were filled. Serevent's sales were $639 million last year, and Foradil's $320 million.
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