FDA Indicates No Apparent Link between Singulair and Suicide

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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.

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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.

Tags: Chantix, Singulair, Suicide

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4 Comments

Gabriel
That test sounds ridiculous. It wasn’t even a test, it was a survey of a prior test years before on a different subject… I have a giant slit on my wrist with nothing really going wrong for me at the time, it just seemed like the right thing to do to myself. Anyway, abit later off Singulair and I’m doing much better. And the joke is, it was great for my allergies
Alexis
Not a link! What a laugh! My daughter has been on it since it she was 6/7and the longer she took it the wost she became. She is now in a behavioral hospital taking antidepression drugs. My daughter”s pediatrition didnt take take her off I did but she didnt improve. She has became so aggressive toward use we finally put her somewhere she could receive the help she needs. I only pray its reversible. Everbidy else on this site was short term users she has been on this meds for 6/7 years and I pray I can get my child back.
Alicia
I find it kinda of amusing myself. It’s amazing what can be shoved under the rug for a little bit of money. I have a 10 year old son and he was placed on singulair over a year ago. After a few months of treatment with the drug, he became depressed and suicidal. At one particuar time he was unloading the dish washer, picked up a knife and started crying. When I asked what was wrong he said and I quote “the devil told me to kill myself”. I immedietly called my physician and they took him off of the drug. He has been happy and not wanting to “kill himself” every since. And there is no link to Singulair……..GIVE ME A BREAK!
Kelly
I find it amusing that the FDA reviewed the findings of Merck’s data, knowing that it is a top grossing drug for the company. When was that data collected? Was it collected with the goal of determining if there was indeed a link? My guess is no. My husband was a Singulair user and when he became so ill that he couldn’t stay at his job of ten years, not one of the psychiatrists, GPs or therapists he saw once flagged the drug for the cause of his illness. So much for warnings. When the warning did come last March (2008) he went off the drug and the symptoms abated within a few weeks. No more migraines, tremors, horrific nightmares, mood swings, suicidal thoughts, and mystery pains in his limbs. He is not alone in this experience, there are stories all over the internet that are virtually the same. This drug has left my family personally and financially in ruins. Did the FDA check up on these stories when it made it’s pronouncement or was it all based on the fat pockets of Merck? We never signed on to be lab rats.

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