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FDA Requests Labelling Change for Asthma Medications ROCKVILLE, Md -- June 12, 2009 -- The US Food and Drug Administration (FDA) today provided further updated safety information on leukotriene modifiers. The FDA has requested that manufacturers include a precaution in the drug labelling regarding neuropsychiatric events that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behaviour (including suicide), and tremor. Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications. Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms. Background In April 2009, the FDA completed its review of neuropsychiatric events possibly related to drugs that act through the leukotriene pathway (montelukast, zafirlukast, zileuton). As part of its review, FDA reviewed post-marketing reports and also requested that manufacturers submit all available clinical trial data for these products. The post-market reports of patients on these medications included cases of neuropsychiatric events. Some reports included clinical details consistent with a drug-induced effect. In the clinical trial data submitted by manufacturers, neuropsychiatric events were not commonly observed. However, the available data were limited because the trials were not designed to look for neuropsychiatric events. Sleep disorders (primarily insomnia) were reported more frequently with all 3 products compared with placebo. Adverse reactions or quality problems experienced with the use of these Products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax: 1-800-FDA-0178 Fax https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm Regular Mail: Use postage-paid FDA Form 3500 MedWatch 5600 Fishers Lane Rockville, MD 20852-9787 SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version