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Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions
Pediatric Pulmonology, 05/18/09

Bisgaard H et al. - The clinical and laboratory safety profile for montelukast was similar to that observed for placebo or active control/usual care therapies. The safety profile of montelukast did not change with long-term use.

Exclusive Author Commentary
Hans Bisgaard, 06/06/09

This review summarizes the safety and tolerability data—particularly the most common adverse experiences—for seven placebo-controlled, double blind, pediatric studies and three active-controlled open-label extension studies of montelukast in children 6 months to 14 years of age. The conclusions from this review are in agreement with previously reported safety data for montelukast. Commonly reported adverse experiences were upper respiratory infection, worsening asthma, pharyngitis, and fever.

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