Saturday, September 06, 2008
In March 2008, in a pre-emptive move, Merck announced that its allergy/asthma drug, Singulair, might cause some people to act on suicidal thoughts. They didn't have any scientific evidence yet, but anecdotal evidence from patients had been coming in. The risk was serious enough that they felt they sh...
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So where is the news-media now? When this "story" hit it was covered and reported EXTENSIVELY by the media. Every morning show discussed it and pediatricians in particular were swamped with concerned phone calls from parents. Physicians who had been prescribing the product for ten years could not convince parents that based on their experience they felt that the product was safe. Many parents took their children off the medication without consulting their physicians, exposing their child to potential asthma exacerbations by not having them on a controller medication, which was doing the job it was intended to do and one that the child would take daily. Has anyone seen this reported in the media? Has this been covered at all? Where are all those "television" doctors that provide the latest medical news now? The same ones that in March scared all the parents whose children have asthma. What about the print media? Have they covered this development at all or is it buried in the back of the paper where no one will see it? Maybe the drug companies aren't as bad as the media leads us to believe.
I have to agree with you, but it's a sad fact that bad news sells -- good news doesn't, or at least not as well.
There's a reason this so called "good news" didn't sell. It proves NOTHING!
Did you know that the study, entitled "Montelukast and emotional well-being as a
marker for depression: Results from 3 randomized, double-masked clinical trials" involved only 1469 patients, 569 of whom were randomly assigned to montelukast? Follow up data on emotional well being was available for 1352, of whom 536 were assigned to montelukast.
The first trial enrolled 480 patients, of whom 239 were assigned to montelukast for 4 weeks.
The second trial enrolled 500 patients, of whom 165 were assigned to montelukast. Of the 500 patients, 108 were between the ages of 15 and 25 years, and 96 were children ages 6-14 years. Of the 96 children, 32 were assigned to montelukast. The treatment duration was 16 weeks.
The third trial enrolled 489 patients, of whom 164 were assigned to montelukast for 24 weeks; 20% of patients were between the ages of 15 and 25 years.
Do you really think this is sufficient evidence to conclude that there is no link beteween Singulair and suicide? Almost 31 million US prescriptions were written for Singulair in 2007. This drug was tested on approximately 3.5% of this population!
Psychiatric disorders, which are involved in 90% of suicides according to the NLM, are documented post-marketing adverse effects of Singulair. Anxiety and depression were reasons three participants taking montelukast (Singulair) dropped out of the clinical trials. In the medical review for Singulair on the FDA's website, it is documented that a participant taking montelukast developed depression that the researcher considered drug related.
The thousands of posts on medications.com, mostly from parents whose children developed anxiety and depression, experienced suicidal thoughts and actions, suffered seizures, ADHD symptoms, OCD symptoms, vocal and motor tics and a slew of other psychiatic ills while taking Singulair; the FDA AERS reports on patientsville.com; the adverse reaction my son had (which included anxiety, depression, and him wishing he was dead so he wouldn't have to feel so horrible); and the devastating adverse reactions of the children of my friends; lead me to believe, without a doubt, that Singulair is NOT SAFE!
Yea, there's nothing "good" about the news that the FDA is dragging their feet on this drug.
A simple Google search will show you how many lives this drug has ruined, hopefully temporarily.
I took a single dose back in June, landed in the hospital and am still trying to recover from panic disorder because of it. (Had NONE for the first 40 years of my life prior.)
This drug is poison, and it's criminal that people are profiting from it. The author of this article should be ashamed.
Sorry, but I am NOT ashamed of writing this article... MORE THAN 2 YEARS AGO. I was simply reporting on what was known at the time. The American Lung Association, a trusted nonprofit had studied what was in evidence at the time (as compared to anecdotal stories, which never carry as much weight as scientific evidence). At that point in time, there did not appear to be a direct link between acting on suicidal thoughts and taking Singulair.
That may no longer be the case; I haven't studied recent research extensively at this writing. I didn't draw the conclusions I reported in this article... the ALA did. I was just a reporter for them.
Kathi
Fair enough, Kathi. I shouldn't have been so harsh. I just feel strongly about this drug for the obviuos reasons. I hope this situation rights itself.
re:Sorry, but I am NOT ashamed of writing this article... MORE THAN 2 YEARS AGO. I was simply reporting on what was known at the time. The American Lung Association, a trusted nonprofit had studied what was in evidence at the time (as compared to anecdotal stories, which never carry as much weight as scientific evidence). At that point in time, there did not appear to be a direct link between acting on suicidal thoughts and taking Singulair.
That may no longer be the case; I haven't studied recent research extensively at this writing. I didn't draw the conclusions I reported in this article... the ALA did. I was just a reporter for them.
Dear Kathi:
I respectfully ask that you take the opportunity to study the recent research before you write on this subject. In 2009 the FDA updated its investigation and required that Singulair's label contain new warnings. Here is a quote from the FDA update:
"The post-market reports of patients on these medications included cases of neuropsychiatric events. Some reports included clinical details consistent with a drug-induced effect. In the clinical trial data submitted by manufacturers, neuropsychiatric events were not commonly observed. However, the available data were limited because the trials were not designed to look for neuropsychiatric events. Sleep disorders (primarily insomnia) were reported more frequently with all three products compared to placebo."
In other words, the FDA concluded that Singulair is associated with these dangerous neuropsychiatric side effects, which include anxiety, depression, and suicidal thoughts.
This drug is prescribed to millions of very young children, as well as to adults. Could you imagine as a parent, what it is like to have your six-year-old become depressed, anxious, withdrawn and say things like "I wish I was dead"? And then finally realizing that his asthma medication could do this to him, only because other parents were willing to speak out. And then after stopping the drug, and seeing him recover, start to smile again, realize just how much damage this drug had caused. Then to watch as places like the American Lung Association are used by the pharmaceutical companies to try and suppress the truth about this drug. And then to see this whole issue swept under the carpet even after the FDA found evidence. The public counts on people like you to dig a little and find the information that can help them. Have you really done all you can do? Start by visiting www.parentsforsafety.org.
While I appreciate your concerns and your input, I DO my due diligence research when I write articles. The original article was written in 2008, before the 2009 publication you reference. I understand that more current information paints a different picture about this medication, although it continues to be sold in the U.S. and prescribed by expert physicians.
It is not fair to criticize me for writing a post on what was known at the time (please check the dates on posts before you accuse me of not doing my research). I am a freelance health writer for HealthCentral, and as such I am not paid to continuously update every post I have ever written.
Still, I do my best to respond to the welcome comments such as yours and the other ones here, however. And hopefully, the article taken together with the discussion afterwards, paints a more complete picture.