FDA Updates Information Regarding Singulair and its Relation to Suicide

Today the FDA issued further information regarding its investigation between the drug Singulair, a drug used for treatment of asthma and allergies, and suicidal thinking and behavior, as well as suicide itself. I previously wrote about this concern when it was first raised back in March of 2008 here. The FDA has asked manufacturers of all products used to treat asthma and allergies to submit information about suicide related adverse events, as well as mood and behavior related adverse events which the manufacturers of these products had obtained through its clinical trials on these drugs.
The bottom line so far is that the clinical trial data provided by the pharmaceutical companies, including Merck, the manufacturer of Singulair, does not appear to show a causal relationship between Singulair and issues of suicidality. Only one adult patient out of 9,929 patients treated with Singulair during the clinical trials showed indications of thinking about suicide or what is referred to as suicidal ideation. The FDA is continuing to review this clinical trial data to see if there is any indication of other mood and behavior adverse events related to the drugs and it has not reached any conclusions about whether a causal relationship exists.
The FDA is also looking at post marketing reports of neuropsychiatric events with regard to Singulair, as well as Accolate and Zyflo to compare the Adverse Events for each of these drugs which are somewhat similar. Most of the neuropsychiatric events received thus far are for Singulair and the information provided is consistent with a drug induced effect. The FDA indicates it will continue to evaluate this issue and update it in the near future.
At the very least, it is good to see the FDA being proactive and providing information regarding ongoing investigations. Should further information be forthcoming, I will provide additional posts. If you or someone you know have had suicidal thoughts or feelings while taking the drug Singulair, first contact your physician immediately. Also, make sure you advise the FDA by going to www.fda.gov/medwatch/report.htm.