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Cumulatively, 426 pediatric patients 2 to 5 years of age were treated with Singulair for at least 3 months, 230 for 6 months or longer, and 63 patients for one year or longer in clinical trials. In pediatric patients 6 to 23 months of age receiving Singulair, the following events occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo, regardless of causality assessment: upper respiratory infection, wheezing; otitis media; pharyngitis, tonsillitis, cough; and rhinitis. Food and Drug Administration said Thursday it was investigating the possibility of an increased risk of mood changes and suicidal behavior among those who take the highly popular asthma drug Singulair. Singulair administered once daily was generally well tolerated, with a safety profile consistent with that observed in patients with seasonal allergic rhinitis and similar to that of placebo. If you have only allergies, you can take Singulair at any time. The frequency of less common adverse events was comparable between Singulair and placebo.

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