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Ask The Expert

April 6, 2017

Anti-leukotriene drugs


Many parents are aware of the reports of depression and anti-leukotriene agents. Yet, in many countries, including here in Australia, these agents are still listed in guidelines for childhood asthma. What is the real risk of depression? How long does it take to manifest, if it is going to occur?


By Prof Luis Felipe Ensina Chiaverina

A series of post marketing case reports of neuropsychiatric events induced by anti-leukotriene modifying agents led the FDA to issue an alert in March 2008 and then to include neuropsychiatric adverse events as a precaution on the drug label in June 2009.  Depression, among other neuropsychiatric disorders, could be induced by these drugs in adults, adolescents and pediatric patients, but seems to be more frequent in adolescents than in adults or children.  Although the risk of depression and other neuropsychiatric disorders is increased in patients taking anti-leukotrienes, these adverse events are still considered very rare, and the benefits outweigh the risks in asthma.  However, it is important to look for neuropsychiatric disorders before starting the therapy, and also monitor the occurrence of symptoms during treatment.


  1. FDA. [Accessed December 28, 2016] Early Communication About an Ongoing Safety Review of Montelukast (Singulair). PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm070618.htm
  2. FDA. [Accessed December 28, 2016] Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR). PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm165489.htm
  3. [Accessed December 28, 2016]
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  6. DOI: 10.1007/s40264-015-0360-2

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