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The U.S. Food and Drug Administration recently issued a safety review update regarding an increased risk of suicidal thoughts and behaviors associated with the use of the leukotriene inhibitor montelukast (Singulair). The drug is prescribed to treat asthma and allergic rhinitis in both adults and children. The leukotriene inhibitor class of drugs also includes zafirlukast (Accolate) and zileuton (Zyflo, Zyflo CR). However, the study data evaluating the incidence of suicidality showed no association with these two drugs.

An interim report was compiled and released by the FDA after review of 41 placebo-controlled clinical trials of montelukast use in patients age 6 and older, 45 placebo-controlled clinical trials of zafirlukast use in patients age 5 and older, and 11 placebo-controlled clinical trials of zileuton use patients age 12 and older. The data revealed that one patient taking montelukast reported suicidal ideation; no suicidal ideation was reported with zafirlukast or zileuton. The agency was concerned, however, that the studies were not designed to specifically examine neuropsychiatric events, such as suicidal thoughts or attempts; as a result, some events may not have been reported.

It is important to note that the FDA continues to collect data on all three medications and strongly encourages consumers and providers to report any adverse events, including suicidal thoughts and behaviors.

Patient monitoring: Closely assess patients for notable or unusual changes in mood, behavior, or actions that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

Patient teaching: Stress that changes in medications should not be made without first talking to the prescribing healthcare provider. Healthcare providers should also notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors when leukotriene inhibitors are prescribed. Patients should be closely observed for notable changes in behavior, including withdrawal from friends and family, becoming depressed or worsening of previous depression, thinking or talking about death, and giving away prized possessions or belongings.

Caution: Review current drug information before administering and monitoring medications.

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Drug News is compiled by Susanne J. Pavlovich-Danis, RN, MSN, ARNP-C, CDE, CRRN, who maintains a private practice in Plantation, Fla., and is professor and area chair for nursing at the University of Phoenix, Fort Lauderdale.