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Two Asthma Meds May Be Too Risky, FDA Panel Says
Date:12/11/2008

g daytime and night-time symptoms and decreasing the use of rescue medications. For Advair, there was no evidence of increased risk for asthma-related death, asthma-related hospitalization, asthma-related intubation and all-cause death in any database. Therefore, no regulatory action is necessary for this product."

And Novartis noted, "Given the benefits associated with long-acting beta 2-agonist use in asthma, Novartis believes that the benefit-risk ratio is in favor of formoterol use as currently reflected in labeling and treatment guidelines. Long-acting beta 2-agonists, including formoterol, remain an important therapeutic option in the treatment of patients with asthma."

More information

For more information on asthma, visit the U.S. National Institutes of Health.



SOURCES: Miles Weinberger, M.D., professor, pediatrics, University of Iowa, Iowa City; U.S. Food and Drug Administration briefing documents; Dow Jones


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