Safety Alerts & Recalls
What does this mean?
Today's alert is to inform you that the updated prescribing information is now available to the public, and can be viewed on the FDA website: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165489.htm
If you have any questions or concerns about Zileuton, please follow up with your doctor or pharmacist.
Updated Prescribing Information Available
In a follow up to the FDA's June 2009 communication "Update to the Follow Up to the Early Communication about an Ongoing Safety Review for Leukotriene Inhibitors," the FDA and the manufacturers of montelukast (Singulair), zafirlukast (Accolate), zileuton (Zyflo) and zileuton extended release (Zyflo CR) are announcing an update to the Precautions section of the prescribing information to include information about mood and behavior problems reported in patients using these products. The reported mood and behavior problems include cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.
The FDA's initial request for the addition of these reports of mood and behavior changes to the prescribing information for Zileuton was described in the June 2009 iGuard alert available at: more information here
Singulair 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. Accolate, Zyflo, and Zyflo CR are used to treat asthma.