The FDA says it has found no association between certain asthma medications and specific mental health risks.
The agency has reviewed safety data on the asthma drugs Accolate (AstraZeneca), Singulair (Merck), Zyflo and Zyflo CR (both made by Cornerstone Therapeutics), evaluating the medications for mood and behavior changes, suicidality (suicidal thinking and behavior) and suicide risk. The agency began reviewing clinical trials in March 2008.
The FDA says its review of clinical trials for asthma drug safety "do not suggest" a link, although none of the studies that the FDA examined specifically looked at suicide risk or suicidality.
In the 45 Accolate trials, there was one suicide and one case of suicidal thinking in the placebo group, and none of either in the patients taking Accolate. In 11 zileuton trials (the active ingredient in Zyflo and Zylfo CR), there were no reports of suicide or suicidality in either the placebo group or in individuals taking the medications. There was one report of suicidal thinking in the 41 clinical trials of Singulair, which included nearly 10,000 patients taking the drug.
None of the studies compared the drugs to each other. The FDA will continue its safety review to determine if there is a connection between the asthma medications and mood or behavior changes.