Labeling for Leukotriene Inhibitors Describes Adverse Neuropsychiatric Events

Kate Traynor

BETHESDA, MD 31 August 2009—FDA on Friday announced that the labeling for leukotriene inhibitors now includes information about reports of neuropsychiatric events in patients who used the products.

The labeling revisions follow a safety review that FDA first announced more than a year ago. At that time, the agency was evaluating whether Singulair, Merck's montelukast sodium product, was associated with behavior changes, suicidal thoughts, and suicide.

The review was later expanded to the leukotriene inhibitors zafirlukast, sold as Accolate by AstraZeneca, and zileuton, sold as Zyflo by Cornerstone Therapeutics, FDA announced this past January.

According to FDA's latest MedWatch update on the leukotriene inhibitors, new information appears in the Precautions section of each product's labeling.

The revised labeling for Singulair (PDF) states that agitation, aggressive behavior or hostility, anxiousness, depression, dream abnormalities, hallucinations, insomnia, irritability, restlessness, sleepwalking, suicidal thinking and behavior, suicide, and tremor have been reported in adults, adolescents, and pediatric patients treated with the drug.

The Precautions section of Accolate's labeling (PDF) states that reports of insomnia and depression have occurred in adults, adolescents, and pediatric patients.

For Zyflo (PDF), the Precautions section describes sleep disorders and behavior changes as adverse neuropsychiatric events that have occurred during treatment in adults and adolescents.

FDA stated that patients should tell their health care provider if neuropsychiatric symptoms develop during treatment with a leukotriene inhibitor. According to the agency, prescribers should be aware of the possibility that adverse neuropsychiatric events may surface during leukotriene therapy and should consider halting treatment if these problems occur.