The Food and Drug Administration (FDA) has asked the manufacturers of three popular asthma medications to add new warnings to their labels, indicating that the drugs could increase the chances of severe asthma episodes that can result in death.
Advair, Serevent, and Foradil
The warnings would be placed on the bronchodilator medicines Advair and Serevent, made by GlaxoSmithKline, and Foradil, which is made by Novartis AG. Patients use them on a daily basis to relax bronchial muscles and prevent asthma attacks.
Only if All Else Fails
In a public health warning issued on its Web site, the FDA said that these drugs, and others in the same class, which are collectively known as long-acting beta 2-adrenergic agonists (LABAs), should only be used if other medical treatments have failed.
Best-Selling Drug
Advair is GlaxoSmithKline's biggest-selling drug, and the company's asthma drugs account for about 15 percent of their total sales. The company disagreed with the FDA's proposed labeling changes, arguing that they were inconsistent with established treatment guidelines.
Serevent and Advair already have a "black box" warning as a result of a study showing that Serevent patients had a higher risk of life-threatening asthma attacks and deaths.