Leukotriene Inhibitor Warning
Since this article does not have an abstract, we have provided the first 150 words of the full text.
- KEYWORDS:
- ASTHMA
- DRUG REACTION, ADVERSE
- LEUKOTRIENES
- MENTAL DISORDERS
- MONTELUKAST
- PRODUCT SURVEILLANCE, POSTMARKETING
- RHINITIS, ALLERGIC, SEASONAL
- ZAFIRLUKAST
- ZILEUTON
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.
The agency has received postmarketing reports of agitation, aggression, anxiousness, abnormal dreams, hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor in patients taking these drugs. Physicians and patients should be aware of such potential adverse …
