Singulair linked to serious mood and behavior issues

United States' Food and Drug Administration (FDA) has announced that it is evaluating available information for a potential link between some serious issues involving mood changes and behavior affecting patients who take Merck & Co, Inc's Singulair (montelukast).

Singulair is a prescription drug for the treatment of asthma, allergic rhinitis, and the prevention of exercise-induced asthma. Accordingly, it has been associated with unlikely mood changes, suicidal thinking and behavior (suicidality), and suicide. Merck & Co, Inc has made several changes to the patient and prescriber information issued for Singulair and has worked with the FDA to determine how to communicate the latest changes in the most effective manner.
Updates on the drug include alerts for adverse reactions and recently has included tremor, depression, suicidality, and anxiousness. Plans to increase awareness of these potential side effects include personal interaction with prescribers and information leaflets for patients. Merck is conducting a re-evaluation study for Singulair and the FDA is reviewing patient reports of adverse reactions while taking Singulair. The FDA anticipates the review and evaluation process may take as long as nine months before firm data is available for public release.
Singulair is a leukotriene receptor antagonist with mechanism of action similar to Accolate (zafirlukast). Another popular drug used for the treatment of similar symptoms is Zyflo/Zyflo CR (zafirlukast), which is a leukotriene synthesis inhibitor. The FDA is also reviewing reports of similar adverse reactions reported in patients taking these medications to determine if further investigation should be made.
Patients and physicians are requested to report any incidence of these adverse reactions while taking any of these drugs. The FDA has a program for reporting adverse reactions, the MedWatch Adverse Event Reporting program, that can be accessed by:
going online to www.fda.gov/medwatch/report.htm,
by calling 1-800-332-1088, or
by faxing to 1-800-FDA-1078.
Source: FDA