FDA Investigating Behavior Changes with Asthma Medication

06/18/2009 - News

FDA Investigating Behavior Changes with Asthma Medication

By: June Chen, MD


On Friday, the Food and Drug Administration (FDA) released a statement about their ongoing investigation of a possible association between use of the asthma and allergy drug, montelukast (marketed as Singulair®), and the development of behavior or mood changes, including suicidal thoughts and suicide .

Although the safety alert informs doctors and patients that the FDA is investigating this possible link, it does not mean that the FDA has reached any definitive conclusions about the relationship. It also does not mean that the FDA is advising healthcare professionals to stop prescribing montelukast.

Last year, the maker of Singulair® updated the prescribing information and patient information for the drug to include the following adverse events which were reported after marketing of the drug -- depression, suicidal thinking and behavior, and anxiousness. The FDA will be studying these emerging safety issues to determine if regulatory action is required. The FDA said it would probably take at least nine months to complete their safety review, but as soon as the review is complete, the FDA will communicate its conclusions and recommendations to the public.

In the meantime, patients taking montelukast should not stop taking the medication without talking to their doctors. And, both patients and healthcare professionals should carefully monitor for behavior changes and report side effects to the FDA's MedWatch Adverse Event Reporting program.


U.S. Food and Drug Administration

Created on: 03/31/2008
Reviewed on: 06/18/2009

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