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FDA Recommends New Warnings for Certain Asthma Drugs

On Friday, the FDA provided a follow up report from their March 2008 and January 2009 safety reports regarding a certain class of asthma drugs known as leukotriene modifiers. The FDA is now recommending a label change, wherein manufacturers should include in their label a warning concerning neuropsychiatric events that have been reported. The drugs that are affected by this recommendation are: montelukast (brand name Singulair), zafirlukast (brand name Accolate), and zileuton (brand name Zyflo and Zyflo CR). The neuropsychiatric events that have been reported are mostly behavioral, such as mood changes, anxiousness, dream abnormalities, and hallucinations.

Leukotriene modifiers are drugs that mainly are used to treat asthma, but some are also used for allergies. Leukotriene is a chemical released by the body in response to an inflammatory stimulus such as when an allergen is inhaled by a person. Montelukast and zafirlukast block the receptor sites for leukotriene. Zileuton is a leukotrine inhibitor, which blocks the production of leuktotriene all together.

For more information on the FDA report, see the FDA press release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm166293.htm

See the Post-market Drug Safety Information:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165489.htm

See the MedWatch information:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166246.htm

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