FDA investigates Singulair risk

Washington -- The U.S. Food and Drug Administration said it is investigating reports of suicidal behavior in patients taking the asthma drug Singulair.

Singulair, which is made by Merck, is used to treat asthma, the symptoms of allergic rhinitis and to prevent exercise-induced asthma, the FDA said Thursday.

Merck has been working with the FDA over the past year to update prescribing information and patient information for Singulair to include the the possible risk of tremors, depression, suicidality and anxiousness. The FDA said it is reviewing the post-marketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Singulair. The agency said it may take up to 9 months to complete the ongoing evaluations.

The FDA said patients should not stop taking Singulair before talking to their doctor. Doctors and caregivers should monitor patients for suicidal thinking and behavior or changes in behavior and mood, the agency said.

Other leukotriene modifying medications, including Accolate, Zyflo, and Zyflo CR, are also being assessed, the FDA said.

Copyright 2008 by United Press International.