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Health Agencies Update
July 22 2009

Leukotriene Inhibitor Warning

JAMA. 2009;302(4):375. doi:10.1001/jama.2009.1048

The US Food and Drug Administration is asking manufacturers of leukotriene inhibitors to add warnings about serious psychiatric adverse events to the drugs' labels. Such drugs are approved for the treatment of asthma and allergic rhinitis.

Since 2007, Merck & Co, Inc, the manufacturer of montelukast, voluntarily added tremor, depression, suicidality, and anxiousness to the list on the drug's label of postmarketing adverse events that have been reported in patients taking the drug. Now, the agency wants a stronger caution on the label of montelukast regarding psychiatric adverse events, as well as similar changes to the labels of asthma drugs zafirlukast and zileuton, which have a similar method of action.

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