FDA reviewing asthma drugs link to mood changes, suicide
NEWS IN BRIEF — Posted April 28, 2008
The Food and Drug Administration is investigating the possible association between the asthma medication montelukast and mood changes and suicide. This possibility is already on the label, but the agency is hoping better to understand and quantify the phenomenon.
The agency also is in discussions with Merck & Co., the manufacturer, about how to communicate this information to physicians and patients.
According to a statement issued by Merck, the company is cooperating with the FDA. The company also highlighted several studies that have failed to substantiate this link.
The review is expected to be completed by the end of this year. Data related to other leukotriene-modifying medications, including zafirlukast and zileuton, also are under review.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2008/04/28/hlbf0428.htm.