FDA Eyes Suicide Links With Merck's Singulair

Law360, New York (March 27, 2008, 12:00 AM EDT) -- Federal regulators are investigating Merck & Co. Inc.'s Singulair amid reports linking the blockbuster asthma drug to mood changes and suicidal behavior in consumers, the U.S. Food and Drug Administration announced Thursday.

Health care workers and caregivers should monitor for suicidal thoughts or behavior adults and children taking Singulair, the FDA said.

The safety review comes after the drugmaker instituted four separate updates in the last year to the labels for montelukast, which is marketed as Singulair.

The series of updates to the prescribing information and...
To view the full article, register now.