I’ve read about suicidal tendencies associated with Singulair and that FDA has published an advisory. What do I need to know as a parent of a child with asthma who has done quite well taking this medication for nearly two years?
–Jean S., Washington, D.C.
Dear Jean,
The Food and Drug Administration (FDA) recently issued an advisory cautioning that behavior and mood changes have been reported in people taking Singulair (montelukast), Accolate (zafirlukast) and Zyflo (zileuton) since the medications came on the market. They have requested that manufacturers add safety warnings to the prescription package inserts.
How commonly or frequently these symptoms occur, we simply don’t know. Some of the things I tell parents to watch for are unusual behavior and/or heightened generalized anxiety, or signs of depression such as isolation from friends, grades dropping or sleeping too much or too little. If you see any of these signs, your child needs to be evaluated by your healthcare provider as soon as possible.
However, your child should not stop taking the medication before talking to your healthcare professional.
I strongly urge parents and/or patients to report any side effects from use of these medications to FDA’s MedWatch Adverse Event Reporting Program. This is the only way FDA will know the magnitude of the side effects.
For more complete information, visit the FDA webpage
When this FDA advisory came out, I contacted Merck, the company that makes Singulair, for more information.
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