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FDA investigation finds no link between Singulair use and suicide


ROCKVILLE, Md. A class of asthma drugs that includes Merck’s Singulair did not appear to increase the risk of suicide, according to an analysis of clinical trials by the Food and Drug Administration.

Last March, the FDA requested data from Merck, AstraZeneca and Cornerstone Therapeutics for data on adverse side effects, specifically suicidal tendencies, from placebo-controlled clinical trials of asthma drugs belonging to the leukotriene receptor agonist class, namely Merck’s Singulair (montelukast), AstraZeneca’s Accolate (zafirlukast) and Cornerstone’s Zyflo (zileuton).

According to an FDA update on the analysis of the studies, all three submitted data on thousands of patients treated with the drugs or placebos, but no patients completed suicide. In the Singulair study, one patient out of the 9,929-patient study group had suicidal thoughts, but did not commit suicide. There were no reports of suicidal thoughts in the other two studies.

The agency said it will continue reviewing clinical trial data to assess other psychiatric side effects, such as mood problems. As such, it has not reached a definitive conclusion.

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