FDA Indicates No Apparent Link between Singulair and Suicide

In a statement released yesterday, the FDA indicates that while they are continuing to look at data involving potential behavior side effects of Singulair, the agency has not found evidence to suggest that the asthma drug is associated with an increased risk of suicides or suicidal behavior.

In March 2008, the FDA released an early communication to notify the public that they were initiating an investigation into a possible association between Singulair (montelukast) and behavior or mood changes, suicides and suicidal thinking. At that time, they indicated that their preliminary review would take about 9 months before they would draw any conclusions or make recommendations to the public.

After reviewing data submitted by Merck and the manufacturers of other asthma drugs, the FDA indicates that there is no apparent link between Singulair and suicide, although the studies reviewed were not designed to specifically evaluate that risk.

To review the risk of suicide, Merck provide data for 9,929 individuals treated with Singulair and 7,780 individuals who received a placebo. Only one adult treated with Singulair was found to have suicidal ideation or thoughts, and none of the Singulair users had completed suicides, suicide attempts or preparatory acts.

The FDA indicates that they are continuing to review clinical data involving other neuropsychiatric events, such as mood and behavior changes, and no definitive conclusion regarding the association with Singulair has been reached.

According to Merck, data submitted to the drug regulatory agency involving the behavior and mood change analysis, which involved 11,673 individuals treated with Singulair and 8,827 who received a placebo, the incidence of behavior-related events was 2.73% for Singulair and 2.27% for the placebo group.

The warning label for Singulair side effects has been updated several times to reflect potential risks of depression in April 2007, suicidal thinking and behavior in October 2007 and anxiousness in February 2008.

The FDA’s initial announcement in March 2008, about their investigation of the potential suicide risks, came a few months after concerns emerged about suicide side effects of Chantix, a popular anti-smoking drug which has been associated with hundreds of reports of suicides and suicide attempts.

In January 2008, the FDA instituted a new policy which requires drug manufactures to examine potential suicide risks during clinical trials.