Merck’s Singulair Tied To Suicide Reports
The FDA said it is reviewing the issue after receiving reports of mood and behavior changes, suicidal thinking and suicide in patients who took the drug, which is used to treat stuffy nose, sneezing and other allergy symptoms as well as asthma, according to the FDA web site. The agency did not say how many reports it had received.
A definite link to allergy me hasn’t been established, but the agency has asked Merck to evaluate its data for more information on the risk and expects the review to take up to nine months to finish its own review.
The FDA also reviewing reports of behavioral changes in patients taking other similar drugs, including AstraZeneca’s Accolate and Critical Therapeutics’s Zyflo, but hasn’t yet decided whether further investigation is needed. Merck earlier added information about the risk of tremors, depression, anxiousness and suicidal behavior to Singulair’s label.
“We have no indication that anything about the mechanism of Singulair is consistent with these events,” George Philip, Merck’s director of research and product development, tells the Associated Press. “But because suicide is a life-threatening event we thought it was important to provide this information in the product label.”
Bobby C
Hard to pin suicides on allergy meds. Nonetheless, the fact that our country is completely overmedicated, who knows how brain chemistry and general physiology is being screwed up by all these synthetic chemicals.
Dan
Seems that quite a few meds are being correlated with suicide ideology. Maybe just the act is increasing not associated with anything else.
Tom
Today’s early safety communications are a good example of the FDA giving the world what it’s been asking for - advanced notice of possible side effects that haven’t yet been medically confirmed. I think it’s encouraging that FDA is trying to word these announcements in a way that puts their preliminary nature into clear context, and that the agency has been following through with updates when its scientific investigations are complete. (The commish may not go down in history as the Abe Lincoln of FDA, but there are still a lot of good people there who are fiercely dedicated to scientific integrity).
As epidemiologists know, drug safety isn’t a quick or simple process. We’re going to need to pass through a period of mindset change in which we come to accept that some early notifications will lead to new safety warnings and others will be false alarms. Right now, the sudden increase in alerts plays right into the hands of populist fearmongers and it keeps the lawsuit recruiting sites sprouting like mushrooms. Eventually though, I think it will help to reduce the impact of both.
Steve
You know there are so many drugs now supposedly tied to suicide… it just seems fishy… like someone at the FDA has decided that this is their method to sink the ships.
Matt
It seems to me the FDA has been VERY slow to acknowledge suicide as a side effect in any drug - after all it has to protect Big Pharma or otherwise a lot of FDA experts would lose their side jobs.
I don’t think it is too far a streth of the imagination to link suicide with the use of drugs and chemicals unatural to the human body - even if the only link is ‘accidental’ overdose causing death.
In any event there is testimony which supports the fact that people would never have committed suicide had they not been on psych drugs.
HorusCat
Matt,
That’s ridiculous. It would be impossible to prove that someone committed suicide bec of a psych drug because you have no way of rewinding time and seeing what would happen without the person being on the drug. The only person whose testimony would be unimpeachable would be the dead person’s.
Jane
Although the molecular mechanisms underlying psychiatric illnesses such as depression, bipolar disorder and schizophrenia remain incompletely understood, there is increasing clinical, pharmacologic, and genetic evidence that G protein-coupled receptors (GPCRs) play critical roles in these disorders and their treatments.
My understanding of the science is that Singulair and Accolate are both G protien-coupled receptor antaganists whereas Zyflo is NOT a receptor antaganist at all.
Zycro CR prevents the body’s manufacture of leukotrienes which may be responsible for a number of the effects of asthma and allergies.
Lisa Van S
Horus
A teen, with no history of depression or suicidal ideation, is prescribed effexor for migraines,. and then becomes suicidal. Just one of the many who testified in 2004 before the FDA PDAC.
HorusCat
Lisa,
Many people commit suicide and those around them are absolutely flabbergasted. “We had no idea he was upset!” You haven’t proved causality, only concommitancy.
Of course, it kind of begs the question of why he would have received Effexor for migraine. Topamax maybe…there is more here than meets the eye.
Lisa Van S
Horus,
Sure was,.. The neurologist rcved a Grant from wyeth to study effexor for Migraines in adults.
Lisa Van S
Here’s an article that will warm your heart
Psychiatrist has pushed Proffesional Boundaries
Im wondering if he still rcves fees from pfizer
http://cjonline/stories/03278/kan_262180889.shtml
HorusCat
Lisa,
What’s the site? The link won’t connect for me. I think I have to type something more so the spam filter won’t think I am spam. Evidently, a short post makes it think you might be spam.
M Helm, MD
What is really odd about montelukast is that it is a blockbuster multi-billion dollar drug.
For allergic rhinitis it is not as good as a nasal steroid (the best treatment according to several authoritative treatment guidelines). In Merck’s own studies it is not better than loratadine or desloratadine (the “positive control” in most studies). In fact, extended-release pseudoephedrine (not a good choice either) provided greater symptom relief for patients with allergic rhinitis versus montelukast.
For asthma, montelukast is a second-line adjunct to inhaled steroids (in children, but not adults). When used as monotherapy, there are higher rates of asthma exacerbation, higher use of rescue medications, higher overall costs when compared to inhaled steroids (the preferred first-line controller treatment).
It seems to be useful for aspirin-sensitive asthma, nasal polyps and certain odd urticarial conditions.
If it weren’t for consumer directed marketing touting the convenience of a once-daily pill, I wonder it would have even found a niche? Now we find it may not be as safe as water after all.
HorusCat
Lisa,
Never mind. I found it. I don’t think most of that unsavory behavior had anything to do with pharma…and a whole lot to do with a psychiatrist with a personality disorder. I once had a counselor (not an MD) make some very strange suggestions to me about sex. There is a tremendous temptation there for providers because of the power differential. I doubt if Pfizer knew of his, uh, sexual proclivities when they hired him. Maybe I’ll go over to CafePharma and ask if anyone knew about this…reps usually are up on gossip.
As for the Zoloft connection…I think I said before that we did not sell Zoloft for child depression. It is indicated for childhood OCD, though, and most child psychs used it in preference to the other SSRIs because of that indication. In all my years with the drug, though, I can honestly say management never suggested pushing it for kids and depression. So did his association with pharma make him put a kid on medication whom he otherwise wouldn’t have medicated? Probably not. Psychiatrists are trained primarily as medicators…I don’t mean that in a bad way. They are trained to prescribe; most don’t do psychotherapy or counseling. And in the current reimbursement environment, med checks are about all they have time to do. I think this doctor would have prescribed meds for this boy no matter what. Now, his relationship with Pfizer may or may not have influenced his choice of meds. He obviously has very close ties to the company. However, as I said before, almost all child psychs used Zoloft because it had the indication for OCD, whether they had ties to the company or not.
As for whether Zoloft “caused” the suicide or not…we have no way of knowing for sure. The article states the child was emotionally troubled. Why did his parents have him in to see a psychiatrist? Obviously, something unusual was going on. We don’t know what that means. When he became agitated on the drug, it certainly should have been dc’d. His parents do share some of the responsibility there…if your son has been diagnosed as depressed and he becomes anxious, why would you not DC the drug ASAP?
You and I aren’t going to agree about SSRIs and suicidality. But I do think you have to agree that this man’s narcissistic personality disorder and egregiously unethical conduct doesn’t have anything to do with pharma. Look at Bill Clinton…it’s a power thing.
Lisa Van S
M Helm MD
My son’s Pediatrician prescribed Singulair for Asthma, and My son got very ill from it. Took him to a Pulmonary Specialist,.. the specialist told me he would not prescribe this drug for asthma in children. He prescribed albuterol.
Lisa Van S
Horus,
See,… you and I can agree on somethings. I bet you cant wait for Bill to be back in the White House.
Lisa Van S
Horus,
The family moved to a new residence, andd Matt missed his friends.
ol cranky
Lisa:
the leukotriene antagonists are not rescue meds and do not treat bronchospam (albuterol does and it is appopriate first line therapy for asthma). Most pulmonologists were underwhelmed by the singulair data for asthma - it’s marginally helpful for some allergies but not a real mainstay for the treatment of asthma except among GPs/FPs & pediatricians (who are all notoriously bad at diagnosis and managing asthma)
Former pharma Marketing Exec
Horus,
I just hate to be a stickler about these things, but here’s another error you might want to watch out for:
You said” Of course, it kind of begs the question of why he would have received Effexor for migraine. Topamax maybe…there is more here than meets the eye”.
Begging the question is inappropriately used here, you probably meant “of course, it invites another obvious question..”
Begging the question is a logical fallacy where the premise depends on the very matter in question. Otherwise known as a circular argument that gets one no where…
M Helm, MD
Lisa Van S,
Asthma patients should always have (rescue) albuterol handy. Montelukast is not a rescue medicine. The only time a controller (inhaled steroid) is needed is if there are persistent symptoms. I know you don’t mind reading, and you are very health-literate. Search for the National Asthma Education and Prevention Program (NAEPP) guidelines from the NIH/NHLBI - that will be (almost) everything we think we know about managing asthma.
Inhaled steroids (first-line controllers) have not been linked to suicide or increased risk of death. But if your child is fine with albuterol you don’t need anything else. I recommend one cannister should last at least 6 months if symptoms are well-controlled.
HorusCat
Lisa,
Never mind, I found it. I am tempted to go to the Pfizer site on CP and ask if anyone knew about this. Reps are usually pretty up on the dirt about their doctors.
I don’t think you can blame his narcissism and gross abuse of the doctor-patient relationship on pharma. I think he has a severe personality disorder. He’s lucky that other guy didn’t kill him. I once had a counselor make some very weird suggestions to me about things he thought I should do sexually. I was very vulnerable at the time and actually did some of them. I look back at that now and I am horrified. Bad apples exist everywhere…and nowhere are they more dangerous than when the power differential is so great.
As for his use of the SSRIs. I found an article from the NYT…let’s see if I can paste what I copied….
“Many child psychiatrists, who as a group have come to rely on S.S.R.I.’s to treat adolescent depression, seem to think the F.D.A. overreached. Studies have shown that one out of every 20 teenagers has suffered at least one bout of severe depression in his or her life, and adolescent depression can be especially difficult for doctors to manage. Teenagers are often resistant to psychotherapy, and unlike adults, who can quit a job or leave a marriage that might be aggravating their unhappiness, adolescents are almost always stuck with their lots. Doctors who treat young people — child psychiatrists, pediatricians and general practitioners alike — were wary of tricyclics, the previous generation of antidepressants, because of the risk of overdose. (The difference between an effective dose and a lethal one could be as small as six tablets.) But it is much harder to OD on S.S.R.I.’s. While the F.D.A. has approved only Prozac for depression in children and adolescents, doctors are free to prescribe any of these drugs ”off label” for a patient group not specified on the packaging. And they have: between the early 90’s and 2001, the prescription rate of antidepressants for those under 18 more than tripled. In 2002, 11 million antidepressant prescriptions were written for children and adolescents in the United States. Doctors recommended the drugs primarily to treat depression, but also for other emotional problems, from anxiety to shyness to obsessive-compulsive disorder.
The pharmaceutical companies are clearly making a product that most psychiatrists consider critical to treating depressed adolescents. Not prescribing these drugs may very well pose a greater threat than prescribing them. Studies have shown that areas in which antidepressant use among young people is widespread have experienced a dip in teenage suicide rates; according to Dr. John Mann, a suicide expert at Columbia University, fewer than 20 percent of the 4,000 adolescents who commit suicide in America each year are taking or have ever taken antidepressants. ”It would be ludicrous to think that antidepressants could actually contribute to suicide in the United States in any kind of significant way,” Mann told me. ”The vast majority of teen suicides are actually committed in the absence of antidepressants.” ”
They said it more eloquently than I could. Do I think his relationship with Pfizer made him prescribe a medication for this child? No. He is a psychiatrist, and above all, they are trained to prescribe medication. Do I think the relationship with Pfizer influenced his choice of Zoloft? Yes and no. Yes, because obviously there is a close tie there. No, because at the time, and even now, Zoloft is the SSRI of choice for child psychiatrists. They really don’t like Prozac and Zoloft at least has the indication for OCD. They are using a lot of Lexapro, but I think Zoloft is still number one.
Like I said before, I never sold Zoloft for childhood depression and I never experienced anyone in management telling us to do so. In fact, we never really talked much about child psychs and Zoloft because we kind of had the market sewn up until Lexapro came along.
Lisa Van S
Ol Cranky,
I found that out the hard way,… thats why I took him to a pulmonary specialist. I was not happy with the care the pediatrician was giving.
Lisa Van S
M Helm MD
He’s doing great, and thats correct it lasts six months, sometimes it was longer.
M Helm, MD
Ol Cranky,
Please don’t paint pediatricians and GP/FPs with such a broad brush. Not “all [are] notoriously bad.” Doing what I do, knowing what I know and seeing what I see (MD practice patterns and individual patient medication profiles), I can stack my skills against any specialist. The specialists do not find fault with my cognitive skills, and I always try to educate my patients. I’m sure I’m not alone. If a PCP is a “pill dispenser,” they are not likely to do manage very many conditions well.
Lisa Van S
HorusCat
Dont get me started on Dr. John Mann. This man only cares about how much Industry money he can stuff in his pockets.
He’s a paid defense expert for GSK. And a Jury in Cheyenne Wyoming, found GSK’s Paxil caused a triple homicide/suicide. The Jury didnt buy Dr. Mann’s testimony, and I personally dont find the man credible.
Lisa Van S
Horus
NJ Teen Suicide data show that more than 70% of teens who committed suicide were either on or were in withdrawal from antidepressant. He’s an Industry spin doctor..
Bobby C
As a society, we need to engage the slow process of weaning ourselves from these drugs. Hell, it’d be better to drink a bit more wine or toke a few hits, every once in a while to calm nerves. Lotta stress in the world — these pills don’t help.
Nathan
Lisa says: “NJ Teen Suicide data show that more than 70% of teens who committed suicide were either on or were in withdrawal from antidepressant”
Do you have source to back that up? I’d like to see it. I’ve read several articles that imply exactly what Horus said: most suicides victims are dealing with untreated depression.
Lisa Van S
Nathan,
http://www.state.nj.us/health/chs/oisp/documents/ad_suicide07.pdf
Nathan
Lisa, this document is interesting, but it doesn’t support what you wrote. Here’s what it says:
“Approximately forty percent of adolescents in New Jersey who complete suicide have some history of mental illness; slightly over thirty percent are currently being treated for a mental health problem.”
This implies that 60% of adolescent suicide victims have not been diagnosed or treated for a mental health problem and 70% of suicide victims are not currently being treated for any mental health problem. Am I missing something?
Lisa Van S
Nathan,
The 30% & 40% are seperate groups,.. and not one of the same. Sadly what’s missing here are some of the adolescents were steroid users. Illicit and Prescription drug abuse is also missing. Adolescents have snorted antidepressants and then committed suicide, with no history or diagnosis of depression. Teens are known to do stupid things and believe nothing can happen to them.
Lisa Van S
Nathan,
Im curious,.. what did you find interesting?
HorusCat
Lisa,
Bill Clinton back in the White House….sigh. It’s totally off-topic, but I am just amazed at the sexual escapades of powerful people. I am sure it goes on with non-powerful people too, but most of us don’t encounter it in our everyday lives. Clearly, these are people who have more energy than I do!
P,
See? I switched from F to P…thanks for the little lesson in grammar.
Nathan
Lisa,
“The 30% & 40% are seperate groups,.. ”
What makes you think that? Here’s the quote again:
“Approximately forty percent of adolescents in New Jersey who complete suicide have some history of mental illness; slightly over thirty percent are currently being treated for a mental health problem.”
I take it to mean that 40% have some history of mental illness. Of those, 30% are currently being treated for mental illness.
Nathan
Lisa,
My kids are quite young — but thinking to the future I found it interesting that compared to other age groups, adolescents are more likely to commit suicide immediately after a tramatic event. Also I found it interesting that suicide rates have been continuously dropping for the last 15 years — which is consistant with other reports I’ve seen. Also interesting that adolescent suicide rates are higher in densely populated areas whereas elderly suidide rates are higher in rural areas. I don’t know what exactly the make of it, but it’s interesting.
I also found a quote from Horus’s article quite interesting (against thinking about when my girls become teenagers): “Teenagers are often resistant to psychotherapy, and unlike adults, who can quit a job or leave a marriage that might be aggravating their unhappiness, adolescents are almost always stuck with their lots.”
I never thought of it that way. If I get depressed, there is usually something I can *do* about it. (ie change my circumstances) Until my kids get out of high school, they are pretty much stuck. I’ll try to remember that in 10 or 15 years when I’m dealing with hormone-filled emotional teenage girls in my home!
Lisa Van S
Nathan,
You will just have to trust me on this one.
This is why raw data is so crucial,… the data should be placed in the public domaine.
HorusCat
Nathan and Lisa,
Kind of off on a tangent, but there is a town in Wales that is suffering from a sort of suicide epidemic. It appears that the kids are sort of egging each other on…although that’s not quite the way to explain it. Perhaps this phenomenon among teens is one way to explain why teen suicide is higher in densely populated areas…to a certain extent, it is “contagious,” in that teens get the idea from hearing about it. Eating disorders, especially bulimia, are passed from one teen to another–that is, one girl hears about it from another and decides to try it.
It makes you wish you could lock your teenager up until their frontal lobes mature.
Lisa Van S
Nathan,
Actually it is the opposite,..Teens dont want to take medication because theyve been told they have a chemical imbalance of the brain. Teens, especially girls!, are receptive to counseling, as long as the counselor is “their choice”, and not the choice of another. Teens are huge on the trust issue.
Lisa Van S
Horus,
Websites on eating disorders and suicide is a huge problem,..no doubt about that!!!!!
Lisa Van S
Nathan,
“Please”,… remember that hormone-filled adolescents, are not mentally ill, they are actually quite normal. I suggest you get a pair of ear plugs,..stomping feet and slamming doors will become a daily ritual.
HorusCat
And “whatever”…I sometimes thank God I only have boys…although they bring their own set of issues.
Lisa,
I used to suffer from an eating disorder–and I got the idea from a friend of mine, who told me about it. You don’t hear much anymore about eating disorders…I don’t think the problem has gone away, though.
lila
A report from the Netherlands 2006 discusses depression. The report stated that in three cases the onset of the depression after taking Singulair was from 3-14 days.
Discussion and conclusion
Lareb received four reports of depressive symptoms in patients using montelukast.Possible confounding includes that asthma itself has been associated with the development of depression . Inhalated corticosteroids can also exert effects on the central nervous system. Fluticason in combination with salmeterol which is used by patients A, B and D, is associated with hyperactivity and irritability whereas budesonide, which is used by patient C also has been associated with depression .
The latency of montelukast-induced depressive symptoms varies from 3-14 days.
In three of the cases a positive dechallenge was seen. The fact that the patients (except for one) did not suffer from depressive symptoms before they started montelukast, the short latency, and recovery after withdrawal of the drug all strengthen our hypothesis that depressive symptoms are an ADR (adverse drug reaction)related to the use of montelukast.
According to the Marketing Authorisation Holder of montelukast, depression will be added to the product information.
http://www.lareb.nl/documents/kwb_2006_4_montel.pdf
Lisa R.
Hi,
I am prone to depression and I was taking Singulair for about 3 months. I felt fine during that time, but I went off it a few weeks ago. Since then, I’ve begun to enter a deep depression - one that I have never experienced before. I started thinking things I would not normally think about like killing myself. I started to not care how my friends or family would feel if I did this.
I remembered reading an article while I was on Singulair linking it to suicidal thoughts and behavior. I was happy that wasn’t happening to me, but now I wonder if withdrawal from it is causing (or at least contributing to) my recent feelings.
I have been on various medications from Singulair to antidepresssants to birth control. I am finding more and more that you cannot trust these huge drug companies. They only want money - that is ALL they are concerned with. It’s time to look towards herbs and natural remedies for for many of our ailments. There are cultures who have used natural remedies and homeopathy for thousands of years and they are fine. I am not swearing off western medicine, but I believe in so many cases of drugs, they do more harm than good. You don’t even know what the long-term effects are of so many of these drugs, especially those developed in the past 10-20 years.
The drug companies will keep on thriving unless people question their doctors and truly consider what drugs are absolutely necessary and what alternative they can use instead.
truthman30
To Nathan and HorusCat and all the other pharma indoctrinated people who comment here..
How do you think that depression manifests?..
How do you think that anxiety manifests?..
How do you think that Bipolar manifests?…
How do you think that OCD manifests?…
I really would like to know because you claim to have knowledge of these things and you continually promote drugs as effective treatments while also dismissing real patient experiences, real patient opinions and the eveidence which exists of the detrimental effects the drug treatments have had in the real world…
Depression is primarily an emotional disorder, there is nothing unnatural about it, it is a documented part of the human condition and experience which has been written about and expressed since the dawn of civilization…
There is no chemical imbalance , if there is any imbalance it is an emotional one, usually leaning on the negative side to the point of extreme unhappiness with the individuals perception of the world ..
In many ways depression is a more insightful and compassionate view of the way the world actually is..
Yes, the world is painful, yes the world in unfair, yes life can be tough… these are hard truths
Being high on a brain altering medicaton is an unnatural state of being and an unnatural response to a human experience… Peddling drug treatments for emotional experiences based on dubious and defunct scientific theories is fraud no matter what way you look at it..It is fraud ..
Anxiety is a natural response to stress or trauma, to claim that it is also a “mental disorder” is incorrect science …
Anxiety and the fight or flight reaction are survival instincts and a nervous system in overdrive…
To peddle,encourage and push drug treatments as solutions to anxiety “disorders” is fraud…
OCD can manifest in many ways, usually stemming from insecurity , fear and neuorosis..
The only way it can be treated effectively without further damaging the individuals already fragile state is with compassion by a psychologist who needs to gently get to the root of the behaviour..
Encouraging drugs as treatment options for psychological problems is dangerous and is also Based on Fraud …
Bipolar is also deeply psychological in nature with genetic and socio ecenomic factors, it can also manifest from a certain personality type, people who are prone to feel intense lows and intense highs as a reaction to their subjective experiences of the world and their lives..
Pushing drugs on people with personality types based on scientifically unproven psychiatric definitions is Fraud also…
There is no “NORMAL”…
Medications which are marketed, designed and ultimately pushed on people who are deemed “abnormal” by a psychiatric-drug funded-drug cartel is fraudulant , opportunistic and exploititive of the human condition and experience…