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US FDA--Probe of Merck asthma drug safety ongoing

Tue Jan 13, 2009 3:00pm EST

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SILVER SPRING, Md., Jan 13 (Reuters) - U.S. regulators are continuing to review the safety of Merck & Co's (MRK.N) asthma drug Singulair after reports of suicidal behavior, the Food and Drug Administration said on Tuesday.

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"FDA has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioral adverse events associated with" Singulair and similar drugs, the FDA said in a statement updating a probe announced in March 2008.

"We will communicate our conclusions and any resulting recommendations to the public at the conclusion of the review, which may take months to complete," the agency added. (Reporting by Lisa Richwine; editing by Gerald E. McCormick)



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