Advair, Serevent and Foradil Safe to Stay on Market
A US Food and Drug Administration (FDA) advisory panel has declared three asthma drugs from GlaxoSmithKline Plc and Novartis AG safe enough to remain on the market, despite concerns that they may slightly increase the risk of severe asthma attacks, according to a Reuters report on 14 July.
The Glaxo drugs Advair and Serevent already display "black box" warnings that one study showed Serevent patients had a higher (although small) risk of life-threatening asthma attacks and death. The advisory panel ruled that Novartis’s drug, Foradil, which belong to the same drug category of beta-agonists, should carry a similar warning about the study.
The FDA usually follows the recommendations of its advisory panels.
"Until proven otherwise, we have to make ourselves believe [Foradil] may act the same way," said panel member Dr. Steven Gay, medical director of critical care medicine at the University of Michigan Health System, in a report to Reuters.
Novartis said Foradil, marketed in the US by Schering-Plough Corp., acts in a manner different to that of Advair and Serevent, and may be safer. Novartis said it would "work with the FDA to finalize appropriate language," according to Reuters, if the FDA requests a new warning.
Asthma is a chronic condition that affects about 15 million Americans (of which almost 5 million are children). Asthma can cause episodes of coughing, wheezing and difficulty with breathing. Severe attacks can lead to death.
Advair, Serevent and Foradil are inhaled, long-acting drugs that help to relax bronchial muscles and prevent asthma attacks. Panel members said the benefits of controlling asthma symptoms and improving overall lung function outweighed the drugs’ small risk of a life-threatening asthma attack.
The Glaxo study detailed on drug labels reports 13 deaths among about 13,000 patients receiving Serevent for 28 weeks, compared with 3 deaths among about 13,000 people receiving placebo. Severe asthma attacks also occurred when patients received Foradil at a higher dose (which the FDA refused to approve).
Advair is a combination of salmeterol (the active ingredient in Serevent) and fluticasone, another asthma drug. In 2004, global Advair sales totalled $4.5 billion, making it Glaxo’s top-selling product. In comparison, Serevent sales totaled $639 million, and sales of Foradil (generic name formoterol) totaled $320 million.
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Source: Reuters, US panel says 3 asthma drugs should stay on market.
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