Cymbalta

[Music] hello I'm dr. Kevin Landau thanks for watching let's talk about cymbalta or duloxetine this is a drug that gained marketing approval by the Food and Drug Administration in 2004 as a treatment for major depressive disorder depression in for diabetic peripheral neuropathy and then later for treatment as an anti-anxiety agent a treatment for pain in fibromyalgia and treatment for low back pain the drug company wanted it used for stress incontinence but the Food and Drug Administration said no actually when the drug was first presented to the Food and Drug Administration they said the dose is too high it causes high blood pressure there's the potential for liver toxicity at the dose you want especially if consumed with alcohol and not only that you guys have some problems with appropriate manufacturing techniques well the FDA and the company finally got together came out on the market and by 2009 there were about 3 million people each year taking that drug and about 400,000 of those people were taking it for inappropriate reasons for nonspecific musculoskeletal pain for headache maybe a little bit of nerve pain but it was selling at a rate of about 5 billion dollars a year 4 billion of that in the United States also important to realize that the drug was such a big seller that it made up about 15% of Eli Lilly's sales now the drug fits into the category that we call the SN R eyes selective serotonin and norepinephrine reuptake inhibitors that's like an SSRI SSRI that's Prozac and paxil and celexa well this does a little bit more it also works on noradrenaline or norepinephrine and also maybe a smidgen on dopamine but no other area of the brain well the serotonin is important because it's a neurotransmitter and it's important in food regulation and gastrointestinal function and maybe pain perception and the noradrenaline norepinephrine is also very important it's not only a neurotransmitter but it's a hormone as well that works obviously in the brain it's important than cognition and thinking and blood pressure and perception of pain and a series of biologic reactions well let's look at it as an antidepressant does it work very well the company says yes our studies show that the drug is a very good antidepressant and it works in more than 55% of the cases well the company sort of used their own standards they didn't use the standard method that was then current for evaluating antidepressants so since the company funded the studies and since the company judged what kind of comparison scales they should use yes indeed that came out as a relatively good antidepressant now more critically evaluating the drug it was found only to be a smidgen more effective if that compared to a placebo therapy and even while people had depression if it got better while they were taking the drug they had about a 20% chance of relapsing right on therapy so the Cochrane group in 2012 evaluated the drug compared to all the other antidepressants and it said it's no great shakes and that actually wasn't any better than the program or the zoloft or the celexa or any of those other newer anti depressants but they said it has an increased incidence of side effects and as a matter of fact they didn't recommend it as a first-line antidepressant but because it was so heavily advertised because it was on the television all the time people saw it people and the doctors prescribed it and all of a sudden we have a drug that was used and thought to be very good when in reality the quality of the evidence and the supporting material was relatively low and as far as SADS is concerned you know the seasonal effect a depressive disorder well doesn't seem to work very well in that either now it's important to realize that there's this condition called bipolar disorder bipolar disorder is depression plus mania well sometimes it presents his depression and you don't know that you're going to be subject to mania later on and if you take the drug it might precipitate attacks of mania that's very important so something to be careful of so how do other people rate it we already said that the Cochran group said not so good will the International Journal for the Society of pharmaco economics and outcomes evaluated it and they found that effexor actually was more impressive as an antidepressant and then the agency for Healthcare Research and quality evaluated the drug and what they said is that the quality of the evidence suggesting it's beneficial is really poor dafair drug doesn't seem to be any better than say effexor and as a matter of fact both of them seem to be inferior to the older tricyclic antidepressants that have been around forever well in depression and anxiety back in 2012 that was evaluated and actually all of the antidepressants were found to be about the same so it didn't seem to make any difference whether you were taking the locks of teens of Malta or effexor or wellbutrin or whether you were taking trazadone or paxil or prolapse Prozac they all seem to work basically the same well how does it work for anxiety generalized anxiety disorder again if any benefit it's a modest benefit over placebo and even people who have the generalized anxiety disorder who seem to do well when they continue the drug they can also have relapses right on therapy in as a matter of fact the Canadian Psychiatric Association guidelines they don't recommend the drug and a international publication known as the Maudsley prescribing guidelines they rate all of the psychotropic drugs they're not too hot on this drug either well that's a couple damn how about diabetic peripheral neuropathy well we know diabetes affects about two million people every single year get that diagnosis and about 25 to 50 percent so quarter to half of the people going to ultimately develop the diabetic peripheral neuropathy it's a loss of sensation that burning the tingling the aches the shock sensation that occurs specifically in the feet can occur in the hands the diabetic peripheral neuropathy well the problem with this is number one that it's a neuropathy and number two neuropathies aren't specific to diabetes neuropathy could be affected or associated with cancer or HIV the diabetes of course radiation therapy or surgery or inflammation or some kind of injury and the quality of the evidence looking at cymbalta or duloxetine in the treatment of diabetic peripheral neuropathy number one it shows that a higher dose doesn't get any better than the standard dose but a low dose doesn't seem to work and at the recommended dose of 60 milligrams once a day well it takes five people to get one patient who has around a 50% improvement so it works a little better than a placebo maybe but again isn't all that impressive and as a matter of fact the likelihood if you have a diabetic peripheral neuropathy that you get a hundred percent relief from this drug that you'll be cured that the symptoms will go away less than about 15% well comparative studies again show that the old-fashioned tricyclic antidepressants the drugs like admit bromine or amitriptyline they seem to work even better than the cymbalta or the duloxetine and prescribed in turn a tional shows that well maybe get some moderate relief but it's clinically insignificant and as a matter of fact the results of the trials are pretty unconvincing well how that pain is a good for pain well interestingly enough what the company did was when they were evaluating people for depression they got the novel idea let's ask him about pain that hadn't been done before so none of the antidepressants looked at people to see whether they were in less pain after taking the drug well of course if they're depressed we know that pain is going to get worse so when they were doing the studies for depression the company found that when they asked about pain seemed the shoulder pain got better the headache pain got better the low back pain got better so it seems that they might have a good idea here well we know that it was approved for diabetic peripheral neuropathy and fibromyalgia but how about chronic low back pain it finally got approval for that the FDA said on the osteo arthritis pain in the knee they said come on you you really don't have the good information that says it works the drug works maybe about 38% of the time and a placebo works about 30 to 33 percent at the time so it doesn't seem to work all that well but they did get approval for low back pain and it was found by the company studies that it was a little better than placebo but still only about a third of the people who were taking the drug for low back pain seemed to get any better and as a matter of fact in the European spine Journal in research funded by the company the research showed that the drug wasn't any different than taking an aspirin or an Taikan wilson or an antidepressant of any kind or even glucosamine so it doesn't seem to work all that great for pain either how does it work for pain will probably as an antidepressant in those cases where it seems to work now for urinary incontinence they wanted to make a big push but unfortunately for the company the data really didn't show that it was any good and as a matter of fact as far as the pain is concerned when they went to the Advisory Committee the Food and Drug Administration for low back pain it was an eight to six vote in favor of the drug but it was turned down as I said for osteoarthritis of the knee actually in 2010 Forbes magazine put this as one of the most misrepresented drug ads they said as a depression hurts that was the name of their advertising gimmick but that really wasn't legit and the Food and Drug Administration said that they were misrepresenting their claims they were overstating them they were over mitting omitting significant risk information about the drug and they claimed that there was a 50% of the patients who were getting at least 30% reduction in pain the Food and Drug Administration says you don't have any information to suggest that that's true and as a matter of fact side note around that time the drug company had to pay almost a billion and a half dollars for misrepresenting another one of that drugs well let's turn now to fibromyalgia 2% of the population mostly middle-aged women suffer from fibromyalgia also associated it seems with the irritable bowel syndrome chronic fatigue temporal mandibular joint pain these people have widespread somatic pain that sleep dysfunction they have memory problems unfortunately we don't have a good diagnosis a good method of making the diagnosis it's just people who are seem to have widespread pain and maybe have certain areas 11 of 18 areas specific areas of the body where you push on and it seems to hurt well in studies that were done the company showed that if you treat 8 people with fibromyalgia one of them might get about 50% better so modest benefits but it seems to work better in people who have depression so the question always comes up is this drug really just treating the depression or does it have anything specific to do with the fibromyalgia as a matter of fact it is not approved let's say in Australia for treatment of fibromyalgia and per square international showed that it's ineffective for this kind of treatment and as far as the stress incontinence that mentioned a little while ago well it seems that there are too many liver problems too many suicidal events too many side effects with the drug not approved we know about the drug well it's going to not work as well in people who smoke cigarettes because it's not going to be metabolized in the same way it has it basically 12-hour half-life so you can take just one pill a day extensively metabolized in the liver which means if your liver doesn't work you shouldn't take the drug now 70% is going to be excreted in the urine which means if your kidneys don't work don't take the drug food seems to have relatively little effect on the concentration of the drug it's available in 20 30 and 60 milligram tablets there's no evidence that taking any more than 60 milligrams is helpful but there is evidence that it might be harmful you should swallow the pills you shouldn't chew the pills now if you are pregnant or if you're nursing do not take this pill it can cause significant problem too your infant drugs associated with a lot of side effects most of the people who take the drug gonna have at least one side effect sometimes gonna make them too sleepy or make them feel too awake or give them a headache or cause a constipation or dizziness or make them feel sick and it seems to have effects on sexual function moreso in men than in women in five percent there will be a wreck tile dysfunction another five percent lack of orgasm another five percent lack of ejaculation but somewhere around twenty percent of the people or thereabout are going to suffer from dizziness and/or headache and/or a dry mouth and or nausea and about ten percent are going to either be very sleepy with the medicine or constipated with taking the medicine now the Food and Drug Administration specifically says hey if you take this drug you should be very cautious because it can cause liver disease especially if you drink alcohol it can cause hypotension when you stand up you might faint or fall down especially if you happen to be taking an anti hypertensive drug it can cause abnormal bleeding because the drug interacts with serotonin and the serotonin can affect the platelets and the platelets are necessary to clot cause clotting so if you happen to be taking aspirin or if you have a history of gastrointestinal ulcers maybe it got to be a little bit careful it can cause very severe skin reactions it can precipitate the mania that we talked about if you happen to have bipolar disorder if you happen to have a history of seizures can precipitate seizures it can cause low blood sodium and if you get too low of sodium then it can cause headache or weakness or hallucinations or seizures or syncope respiratory arrest and especially if you happen to be relatively young less than say age 24 and taking the drug increased incidence of suicide so young people need to be monitored and anyone taking the drug who all of a sudden becomes agitated or as panic attacks or insomnia irritation irritability hostility impulsivity well those people might be might be a higher risk for suicide it can interact with certain other kind of drugs from sip Road cimetidine or tagamet and some of the antidepressants and you got to be very careful you shouldn't be taking it with a SS RI if you were treated for depression with an MAO inhibitor a drug like par Nate or Nardo or Mar Plan well you shouldn't take the cymbalta within two weeks either way of taking those kind of drugs because it might precipitate very horrible side effects and if you take this drug might lead to something known as the serotonin syndrome either taking it by itself or especially if you happen to have headaches and you take a trip 10 or if you take lithium or if you're taking fentanyl with the drug or tramadol what is the serotonin syndrome serotonin syndrome can cause mental status changes it can cause agitation and hallucinations and delusions in a coma if can cause instability of your autonomic nervous systems are your blood pressure can go up your heart rate can go up you can get dizzy and sweaty and flush and it can cause problems with your muscles it can cause tremor and it can cause rigidity of the muscles in coordination your reflexes might be increased you might actually have seizures and it can cause gastrointestinal disorders nausea vomiting and diarrhea and if you happen to be taking the drug and you want to stop the drug there is something known as the cymbalta discontinuation syndrome the company says that's not really a problem fewer than 1% of the people actually in clinical experience it's up to around half of the people who are taking the drug can't get off it right away at least because if they do it will precipitate in many cases there's cymbalta discontinuation syndrome that may be manifest as dizziness and headache and nausea and vomiting and irritability insomnia anxiety that can cause excess of sweating can cause mood problems seizures headache nausea it can lead to tiredness loss of energy it can lead to irritability and especially electric shock like or what we call brain zaps where you have all of a sudden especially with movement you just feel like you've been zapped by something well we can overdose on the drug too so you got to be careful and not only if you overdose on the drug you could have side effects that could be severe they could range anywhere from vomiting and fainting racing hard tiredness or seizures or coma so the drug has an awful lot of side effects awful lot of baggage associated with it what's the dose well 60 milligrams for most things most diseases is the most appropriate it could be as low as 20 or 30 to start maybe slowly increase to 60 milligrams as appropriate it's kind of an expensive drug even the generics are expensive least expensive probably is at Walmart for 133 dollars cash most expensive generic would be at Walgreens $250 cash but with a coupon from good rx you could get it for as little as 15 to 20 dollars a month but if you want the brand name instead of duloxetine that I just mentioned if you want to go to the cymbalta you could buy that for somewhere north of $250 either with or without a coupon now contrast that to say celexa or prozac you can get those for about $20 a month so going back in summary to press career international what do they say well they say duloxetine is no better than the other available antidepressants but it's associated with more side effects so they recommend against using this drug actually they put this on specifically their list of drugs to avoid and they say that in practice duloxetine well it currently has no place in the treatment of either depression or diabetic Bethy so yes indeed they can advertise the drugs they can say all sorts of wonderful things about the drug and yes we know there are possible effects but when it comes right down to it does the drug really work as stated and the answer is it's sure pretty unimpressive anyway thanks for watching I'm dr. ken land down [Music] you

Channel: wellnowdoctor

Views: 47,404

Rating: 4.6473989 out of 5

Keywords: Cymbalta, Duloxetine, SNRI, SSRI, Depression, Diabetic neuropathy, Peripheral neuropathy, Diabetic peripheral neuropathy, Neuropathy, Nerve pain, Low back pain, Fibromyalgia, Chronic fatigue, Chronic fatigue syndrome, Serotonin, Serotonin syndrome, Effexor, Wellbutrin, Trazodone, Prozac, Paxil, Sexual dysfunction, Suicide, Cymbalta discontinuation syndrome, Withdrawal, Brain zaps

Id: RnY4NGWyF4w

Length: 23min 22sec (1402 seconds)

Published: Wed May 16 2018