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Thousands of patients and parents have complained to the F.D.A. about symptoms of anxiety, rage, hallucinations and other psychiatric problems that they linked to the drug, which is also known in its generic form as montelukast.

La etiqueta de la agencia, dirigida principalmente a los médicos, debía alertar sobre Singulair, un medicamento de 25 años de antigüedad también conocido por su nombre genérico, montelukast.

The agency’s label, which was primarily aimed at doctors, was supposed to sound an alert about the 25-year-old medication, Singulair, also known by its generic name, montelukast.

IntelGenx, a company in Quebec, is performing a clinical trial of an anti-inflammatory asthma drug called montelukast, sold under the brand name Singulair, as an Alzheimer’s treatment.

Montelukast blocks the inflammatory action that a class of proteins called leukotrienes can trigger in the lungs.