Percaution for Leukotriene Inhibitors: Montelukast (marketed as Singulair),

FDA and the manufacturers of Singulair (montelukast), Accolate (zafirlukast), Zyflo (zileuton) and Zyflo CR (zileuton extended release) are announcing an update to the Precautions section of the prescribing information to include information about neuropsychiatric events reported in patients using these products.

      FDA’s request for the addition of this information to the prescribing information for these products was described in the Agency’s June 2009 “Update to the Follow Up to the Early Communication about an Ongoing Safety Review for Leukotriene Inhibitors.”
      Montelukast is used to treat asthma, and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose), and to prevent exercise-induced asthma. Zafirlukast and zileuton are used to treat asthma.

      The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.

Advice to patients and healthcare professionals

#Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.

#Patients should talk with their healthcare providers if these events occur.

#Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.




Source: US Food And Drug Administration, http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165489.htm