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What Else Don’t We Know?

Jan 13 2009 | Comments 5

For years I took Singulair for my asthma and it was a huge help. (You too, Joey, right?) Of course, it was more helpful to quit smoking cigarettes, but that’s another story.

At any rate, it seems Singulair has been under suspicion of causing suicidal ideation and impulses, but Merck’s top-selling drug has—at least in this regard—been given a clean bill of health. From Bloomberg.com:

Merck & Co.’s asthma medicine Singulair and related treatments weren’t associated with an increased risk of suicide or suicidal urges, U.S. regulators said after a review of clinical trials. …

Merck reported in 2007 that it has seen an unusual number of reports of suicidal behavior in Singulair users. Those cases weren’t enough to prove a definitive link and were based of voluntary reports from patients and doctors, Merck said. …

The FDA reviewed 41 Merck-funded studies involving 17,709 patients who received Singulair or a placebo. Of those patients, one person taking Singulair had a suicidal thought compared with none on placebo. No suicides were reported in either group.

Yet the FDA is still analyzing the drug for other side effects and says doctors need to monitor patients who are taking it. So did this drug have an impact on my psychological symptoms? I don’t know; I guess I’ll never know, in fact. But it would have been nice to understand at the time what the implications were for a person with psychiatric illness. Or hell, maybe I was misdiagnosed, and I really just have Singulairitis!

Merck’s Singulair Not Associated With Suicide Risk (Update2)


liz | 5:05 PM | BIG PHARMA, meds

Anthony Says:

Hmmm … “Merck-funded studies.” I wonder how that will turn out?

The TV ads for these drugs last about 30 seconds. The first 5 seconds tell you what the drug treats. Sometimes it’s a legitimate illness like asthma, and other times it’s a fabricated illness like urinating too much.
The next 5 tell you to “Ask your doctor why [drug] is right for you.” The rest of the ad is a fast-reading narrator telling us of the myriad of side-effects.
My favorite is the anti-depressant that may cause diarrhea and excessive yawning.
Sometimes you’re better off with the disease than the cure.

Jan 13 8:02 PM

Andy Alt Says:

This was on the infrequently changing FDA MedWatch page today:

Singulair (montelukast)
Audience: Pulmonologists, respiratory therapists, other healthcare professionals, patients
[UPDATE 01/13/2009] FDA provided updated information to its March 2008 Early Communication. FDA is continuing to review clinical trial data to assess other neuropsychiatric events, (mood and behavioral adverse events) related to drugs that act through the leukotriene pathway (montelukast, zafirlukast, zileuton). As a result, FDA has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioral adverse events associated with montelukast, zafirlukast, and zileuton.

[Posted 03/27/2008] FDA informed healthcare professionals and patients of the Agency’s investigation of the possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a leukotriene receptor antagonist used to treat asthma and the symptoms of allergic rhinitis, and to prevent exercise-induced asthma. Patients should not stop taking Singulair before talking to their doctor if they have questions about the new information. Healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.

Jan 13 8:58 PM

Josh C. Says:

Shazbot!!!

I’ve been on Singulair for 14 months and have never heard of such issues. At least I haven’t been suicidal over the past year. I’ve always been more concerned with the increased risk of asthma-related death associated with the Advair I’ve been taking.

They should advertise both of these medications together with “Highway to Hell” playing in the background.

Jan 14 9:14 AM

Sherry Says:

My friend’s 12-year old daughter has been on Singular for years, along with a shopping bag full of ritalin and other meds. When I mentioned the fact that I just put up with my mild asthma because I’m concerned about the side effects, including loss of bone density, she said her daughter’s orthopod recommended bone density screening because the kid’s broken several bones.

I had to repeat the fact Singular’s a suspect in bone density loss several times before she was able to hear it. I emphasized that I wasn’t recommending she not take give it to her kid, just do some research so she’ll be on top of things. Mother is so afraid of rocking the meds boat she kept blocking out even the suggestion there might be a down side. She said “I’ll ask her doctor about it.” I had to point out that the lung doctor, who’s only interest is in the lungs, isn’t the doc to ask. The one to ask is the BONE doctor. Oh.

When we took this child to summer camp Mother handed me a medium-sized brown paper bag and asked me to hold it for her. I was stunned when she said “Those are Peggy’s meds. We need to take them to the camp nurse.” I was even more stunned when I looked around the cabin and noticed that every kid in the place had an equally loaded paper bag of the same size. What the heck are we doing nowadays???

Jan 14 10:02 AM

Erin Says:

Singulair kept me alive! I was so miserable a couple years back from severe allergies that wouldn’t respond to any normal allergy medication. I wouldn’t have minded, in that stuffed-up, constant state of sneezing, if I just dropped dead. Thanks to Singulair, I don’t suffer from seasonal allergies anymore. It’s the only drug that works for me.

Jan 19 1:17 PM

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