FDA: Updates Singulair Label For Neuropsychiatric Events
June 12 2009 - 2:28PM
Dow Jones News
The U.S. Food and Drug Administration said Friday it was
updating the label of Merck & Co.'s (MRK) Singulair and similar
asthma medications to discuss reports of neuropsychiatric events
such as agitation, depression, insomnia and suicidal thinking.
The new labeling also applies to Accolate by AstraZeneca PLC
(AZN) and Zyflo, by Cornerstone Therapeutics Inc. (CRTX).
The FDA said in a posting to its Web site that "patients and
healthcare professionals should be aware of the potential for
neuropsychiatric events with these medications."
Singulair, one of Merck's top-selling products, is approved to
treat asthma and allergies while Accolate and Zyflo are approved to
treat asthma.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com