FDA Informs Public About Singulair Safety Review

March 28, 2008

The U.S. Food and Drug Administration announced this week that it is investigating a possible association between the use of Singulair (montelukast) and mood and behavioral changes, suicidal thinking/behavior and suicide. Singulair, a leukotriene receptor antagonist, is used in the treatment of allergic rhinitis and asthma.

<p>FRIDAY, March 28 (HealthDay News) -- The U.S. Food and Drug Administration announced this week that it is investigating a possible association between the use of Singulair (montelukast) and mood and behavioral changes, suicidal thinking/behavior and suicide. Singulair, a leukotriene receptor antagonist, is used in the treatment of allergic rhinitis and asthma.</p><p>Merck & Co, Inc., the maker of Singulair, has updated the prescribing information and patient information for Singulair over the past year in response to post-marketing adverse events reported, including tremor (March 2007), depression (April 2007), suicidality (October 2007) and anxiousness (February 2008).</p><p>The FDA is reviewing these post-marketing reports and has requested that Merck evaluate Singulair study data to explore the link between use of the drug and suicidality and suicide. Merck has also agreed to highlight these safety concerns in face-to-face interactions with providers and give providers patient information leaflets about Singulair.</p><p>According to a statement on the FDA Web site, "Patients should not stop taking Singulair before talking to their doctor if they have questions about this new information. Until further information is available, health care professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood."</p><p><a href="http://www.fda.gov/cder/drug/early_comm/montelukast.htm" target="_new">More Information</a></p>

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