The Food and Drug Administration last month called on manufacturers of leukotriene inhibitors to include safety precautions on their drug's labeling, because of reports of neuropsychiatric events in patients taking these drugs.
The FDA said the reported neuropsychiatric events included cases of agitation, aggression, anxiety, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal ideation and behavior, and tremor in patients using montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo, Zyflo CR).
Manufacturers of these drugs were asked to submit all available clinical trial data for these products for the safety review that concluded in April.
In its review, the FDA found that some reports included clinical details consistent with a drug-induced effect.
According to an FDA update from May, most of the reports of neuropsychiatric events were associated with montelukast, which is the most commonly prescribed drug that acts through the leukotriene pathway.
In the clinical trial data submitted by the manufacturers, neuropsychiatric events were not commonly observed, the FDA said. “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 three products compared to placebo.”
The FDA advises that patients and health care providers be aware of the potential for neuropsychiatric events with these drugs used to treat asthma and symptoms of allergic rhinitis. The agency also suggests that physicians discontinue treatment if patients develop neuropsychiatric symptoms.
More information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm079523.htm