Quoted from http://www.reuters.com/article/rbssHealthcareNews/idUSN127331020090612
US FDA asks for caution on Merck asthma drug
Fri Jun 12, 2009 2:50pm EDT
WASHINGTON, June 12 (Reuters) - Merck & Co Inc's Singulair and similar drugs should come with a caution about reports of psychiatric problems in some patients who took the medicines, U.S. regulators said on Friday.
The Food and Drug Administration said it had asked for a precaution on the labels of Singulair, AstraZeneca PLC's Accolate and Cornerstone Therapeutics Inc's Zyflo and Zyflo CR. A precaution is a less serious description than a warning.
Problems that were reported include agitation, aggression, suicidal thinking, suicide, depression, insomnia and irritability, an FDA notice said.
