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FDA panel recommends ban on two beta2-agonists
An FDA advisory panel has recommended a ban on the use of two long-acting beta2-agonists for the treatment of asthma in children — GlaxoSmithKline’s Serevent and Schering Plough’s Foradil.
The advisory committee recommended unanimously to ban the use of these products in children but was divided in its decision for use in adults. The panel agreed that Advair (Glaxo-SmithKline) and Symbicort (AstraZeneca) could continue to be used in adults and adolescents. The panel supported Advair’s use in children by a narrow margin – 13 to 11.
All four medications are taken daily to prevent asthma attacks. According to studies presented by both GSK and Schering Plough, these medications are effective in keeping airways open during asthma attacks, but studies have suggested that they may potentially increase the severity of future asthma attacks, especially among children, if used inappropriately.
GSK officials noted there was an increased risk for serious asthma- related outcomes, including hospitalization, when Serevent was used without an inhaled corticosteroid (ICS) or when the use of inhaled corticosteroids could not be assured.
GlaxoSmithKline and Schering Plough officials released similar statements following the panel meeting.
“Serevent, when used with an ICS, is an important treatment option for some patients as outlined in national guidelines. We are confident that our proposed new labeling, medication guide and risk management plan would help physicians effectively manage the appropriate use of Serevent in conjunction with an ICS,” Ellen Strahlman, MD, chief medical officer for GSK said in a press release. “We are concerned that if the FDA adopts the panel’s recommendation on Serevent, it is possible that Serevent would be severely restricted and deny patients needed treatment for optimal care of their asthma.”
Schering Plough officials wrote, “LABAs are an important asthma treatment option for adults and children whose asthma is not adequately controlled on other asthma controller medications. In a significant number of asthma patients, treatment with ICS alone does not lead to control of asthma symptoms. The National Heart, Lung, and Blood Institute’s Guidelines for the Diagnosis and Management of Asthma recommend LABAs as a preferred step-up therapy to be added for patients whose disease cannot be managed with ICS alone.”