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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 44 to 68 of 8406. Go back in thread:
Posted by pharmrep on August 4, 2002, at 22:20:13
In reply to pharmrep trial question, posted by allisonm on August 3, 2002, at 16:10:16
> The FDA makes drug companies test their drugs for only 8 weeks. But most literature says a depressive ought to take an AD for about a year to make sure the depression is gone. Many of us here take these drugs for years and will do so for the rest of our lives (I'm one of those). It gives many of us pause when we think about that and the possible future ramifications of longterm use. I for one don't like being a guinea pig, but figure the only other choice is death. The chance of getting cancer or some other malady later on because of these chemicals seems like an unfair but necessary (not to mention expensive) alternative to ending my life now. Do drug companies ever go back and study longterm use? Will there ever be any reassurance that these drugs are "safe" save for the lack of reports and warnings if nothing bad turns up?
*** Responsible companies do long term studies as well...there are such studies for Celexa, and I know that Lexapro studies are being done as we speak. The good news about Lexapro is that it is not a foreign matter in the human body. It is half of the Celexa molecule, and has been used by over 30 million people for over 15 years in Europe and the US. As far as the "FDA 8-weeks", you're right, unless there is something obviously wrong, or no separation from placebo, it usually passes.
Posted by Fuscia on August 5, 2002, at 13:09:14
In reply to Re: Lexapro update, posted by pharmrep on July 31, 2002, at 2:04:24
Hello pharmrep,
Do you know what the transport system(s) is for citalopram? The following was posted by James Ferrell, but does not include information about citalopram.
Thanks in advance for any information you can share! Fuscia
Dr. Bob's Psychopharmacology Tips
http://www.dr-bob.org/tips/"Date: Wed, 2 Apr 1997 15:05:51 -0800 (PST)
From: ferrell@cmgm.stanford.edu (James Ferrell)
Subject: Transport systems and antidepressantsHere are some data to give you an idea of what transport systems are
likely to be tweaked by the different antidepressants.From: Bolden-Watson C, Richelson E. Blockade by
newly-developed antidepressants of biogenic amine uptake into rat
brain synaptosomes. Life Sciences. 52 (12): 1023-9, 1993.------------------------------------------------------
Ki (nM)
Drug ------------ Selectivity for 5HT
5HT NE (Ki NE / Ki 5HT)
------------------------------------------------------
desipramine 180 0.6 0.003
doxepin 220 18 0.08
amitriptyline 84 14 0.2
imipramine 41 14 0.3venlafaxine 39 210 5.4
fluoxetine 14 143 10
norfluoxetine 25 410 17
paroxetine 0.7 33 45
sertraline 3 220 64
------------------------------------------------------From: Hyttel J. Pharmacological characterization of selective
serotonin reuptake inhibitors (SSRIs). International Clinical
Psychopharmacology. 9 Suppl 1: 19-26, 1994 Mar.------------------------------------
Drug Selectivity for 5HT
(IC50 NE / IC50 5HT)
------------------------------------
clomiprimine 14
fluoxetine 54
fluvoxamine 160
paroxetine 280
sertraline 840
------------------------------------"
Posted by allisonm on August 5, 2002, at 14:36:29
In reply to Re: trial question, posted by pharmrep on August 4, 2002, at 22:20:13
Sorry. I tend to disagee. A drug is a chemical. There are lots of things that are not foreign matter to the body but which cause disease just the same. Also, I appreciate your enthusiasm about what you sell, but I was not referring to Celexa specifically. I was referring to antidepressants in general. Witness the recent black box warning on Serzone and liver damage, for example. How many years has Serzone been on the market and how many millions of people have used it? That's my point. I remember when red dye #3 (or was it #5?) was withdrawn from the market and there were all kinds of things we couldn't have for awhile until they came up with a healthier shade of red. My memory is vague, but I think Kool-Aid had red dye #3 in it... Certainly, Wellbutrin, Remeron, Effexor, Celexa, Serzone, Prozac, Zoloft etc. have chemicals much less benign than what one would presume to be harmless food coloring...
Thanks.
Posted by pharmrep on August 5, 2002, at 21:39:41
In reply to Re: trial question » pharmrep, posted by allisonm on August 5, 2002, at 14:36:29
Maybe I missed your point. Your original question was regarding long-term studies...I am saying yes, they exist for Celexa as well as other ad's. I am not selling here, so please stop saying that. I was making the observation that Lex is not entirely a foreign substance to the body, as perhaps other new drugs might be "new." Paxil is another one that is not new (just a lowered dose with a different release mechanism)
Posted by pharmrep on August 5, 2002, at 22:37:56
In reply to Re: trial question, posted by pharmrep on August 5, 2002, at 21:39:41
Hey Phil...got a new one today, you heard of this. 250-500 mg of testoserone given once per month. This is supposed to help "speed up" the process...if you know what I mean. I have also heard of the Wellbutrin add-on (called CEL-WELL) to help too.
Posted by allisonm on August 6, 2002, at 10:34:07
In reply to Re: trial question, posted by pharmrep on August 5, 2002, at 21:39:41
>> Maybe I missed your point. Your original question was regarding long-term studies...I am saying yes, they exist for Celexa as well as other ad's. I am not selling here, so please stop saying that. I was making the observation that Lex is not entirely a foreign substance to the body, as perhaps other new drugs might be "new." Paxil is another one that is not new (just a lowered dose with a different release mechanism)<<
Thanks for the information. You did answer my question re' whether there were longterm studies going on. That is good to know.
I understand what you are saying about Lexapro and foreign substances, although I still tend to disagree that because something may not be "foreign" it is safer or less dangerous. They still are chemicals we are adding to our systems that cause desired and undesired effects. We just hope that the desired effects outweigh the undesired ones.
I don't care to get into picking nits, but was is your phrasing re' Lexapro that prompted my comment about your connection with the company that produces the drug. You said: "The good news about Lexapro is that it is not a foreign matter in the human body. It is half of
the Celexa molecule, and has been used by over 30 million people for over 15 years in Europe and the US."I hope you will excuse me: I have worked as newspaper editor and as a PR rep for many years and am sensitive -- or perhaps overly sensitive -- to how things are said, phrased, spun. Phrases such as "the good news about..." and even "which has been used by over 30 million people in Europe and the U.S." strike me as a bit promotional, especially coming from someone in your line of work. If it had been some computer programmer or grocery store clerk who'd been taking it and liked it a lot, I probably would have read past it or chalked it up to enthusiasm or perhaps overzealousness. Trying to talk about a drug from a company that you represent without sounding as though you are promoting it puts you in a difficult situation in that whatever you say is apt to be scrutinized very closely here -- even though your intent is to help and not to sell.
Thanks again for the information.
Posted by pharmrep on August 6, 2002, at 10:52:14
In reply to Re: trial question » pharmrep, posted by allisonm on August 6, 2002, at 10:34:07
No joke...it doesnt matter what I say...some will see it as info, as some will see it as a sales pitch. You aren't the first, but hopefully you will get to know me and see I am trying to be objective with my posts. (not overzealous)
Posted by Anyuser on August 6, 2002, at 17:58:28
In reply to Re: credibility » allisonm, posted by pharmrep on August 6, 2002, at 10:52:14
Here is a link to an article in BusinessWeek about Forrest Laboratories, the makers of Celexa and Lexapro. The founder of Forrest Labs is the father of Andrew Solomon, the author of The Noonday Demon.
http://www.businessweek.com/magazine/content/02_21/b3784001.htm
Posted by Ritch on August 7, 2002, at 9:39:50
In reply to Interesting article, posted by Anyuser on August 6, 2002, at 17:58:28
> Here is a link to an article in BusinessWeek about Forrest Laboratories, the makers of Celexa and Lexapro. The founder of Forrest Labs is the father of Andrew Solomon, the author of The Noonday Demon.
>
> http://www.businessweek.com/magazine/content/02_21/b3784001.htm
Yes, that was indeed very interesting. It would be nice if more pharm. companies would be interested in attempting to market meds that are already available in other countries that could be helpful here. I am thinking of moclobemide for one (why doesn't Roche try to get FDA approval here?). Also, the active metabolite of nortriptyline (I think E-10 OH-nortriptyline), has good anxiolytic properties, downregulates 5-HT receptors, and has nil side effects (that TCA's typically have). Why can't that be developed? Marketing active metabolits of older drugs is becoming more common (fexofenadine and cetirizine, ie.).Mitch
Posted by Geezer on August 7, 2002, at 11:15:45
In reply to Interesting article, posted by Anyuser on August 6, 2002, at 17:58:28
> Here is a link to an article in BusinessWeek about Forrest Laboratories, the makers of Celexa and Lexapro. The founder of Forrest Labs is the father of Andrew Solomon, the author of The Noonday Demon.
>
> http://www.businessweek.com/magazine/content/02_21/b3784001.htmGood article - gives a little balance to the "evil greedy drug company" argument, doesn't it. I wish I had an answer to Mitch's question as to why the FDA won't allow new and better drugs here in the US., after all, the US drug companies do their testing in Europe. I thought it was interesting the FDA "reached out" to Europe and killed the use of Amineptine for Europeans (now it's only available in South America - at a high cost I believe). My only thought would be to "privatize" the FDA (there might be a lot more to the solution than that)- nothing could be worse than the current FDA mess.
Geezer
Posted by SLS on August 10, 2002, at 9:37:13
In reply to Re: Interesting article » Anyuser, posted by Ritch on August 7, 2002, at 9:39:50
Hi Mitch.
How have you been doing?
> It would be nice if more pharm. companies would be interested in attempting to market meds that are already available in other countries that could be helpful here. I am thinking of moclobemide for one (why doesn't Roche try to get FDA approval here?).
First of all, it is my impression that moclobemide is really not a terribly effective drug - either for depression or social-phobia. Of course, some people respond well to it, but the non-selective irreversible MAOIs generally demonstrate superior efficacy. It is certainly worth a try, though. You never know, right?
- Don't give up on moclobemide until you reach 1200mg.
- Do not eat any more than 50mg of tyramine at any one meal.I would be very interested to know what drugs you would combine with moclobemide. Zyprexa would be interesting.
I tried moclobemide in December, 1996. I reacted very, very badly to it. It exacerbated my depression to a degree worse than I have ever experienced. I was curled up in a fetal position on the couch for days, wimpering in pain. No thoughts. Just mental pain.
Roche conducted trials of moclobemide in the US for the indication of social-phobia. I guess they figured they had a better chance of getting the FDA to approve a drug for an indication for which few drugs had yet been approved. The results were poor. I spoke to the head of the US moclobemide project just before it was discontinued. He told me that it was dead and that the trials had been terminated. I doubt they will revisit it.
> Also, the active metabolite of nortriptyline (I think E-10 OH-nortriptyline),
Isn't the parent compound active? What are the differences between them? What other drugs downregulate 5-HT receptors? In what ways does this help with depression? Is it simply an observed association or is there a hypothesis as to how it contributes to producing a remission?
Thanks.
> Why can't that be developed? Marketing active metabolits of older drugs is becoming more common (fexofenadine and cetirizine, ie.).
For every 1 drug brought to market, 100 are synthesized, researched, and discarded for various reasons, including projected profitability. It costs 800 million dollars and 12 years to get a drug approved by the FDA. I imagine there are a few miracle drugs that have ended up in landfills.
- Scott
Posted by Ritch on August 10, 2002, at 11:08:40
In reply to Re: Interesting article » Ritch, posted by SLS on August 10, 2002, at 9:37:13
> Hi Mitch.
>
> How have you been doing?
I have been doing better this summer than I have in *many* summers. I think the L-tyrosine and low-dose Depakote+Effexor+Wellbutrin is making a big difference this time. I am sleeping Ok, and I feel almost normal for a time of year I typically am very depressed. Of course, I am forcing myself to exercise a lot more-so that is contributing too.>
> > It would be nice if more pharm. companies would be interested in attempting to market meds that are already available in other countries that could be helpful here. I am thinking of moclobemide for one (why doesn't Roche try to get FDA approval here?).
>
> First of all, it is my impression that moclobemide is really not a terribly effective drug - either for depression or social-phobia. Of course, some people respond well to it, but the non-selective irreversible MAOIs generally demonstrate superior efficacy. It is certainly worth a try, though. You never know, right?
>
> - Don't give up on moclobemide until you reach 1200mg.
> - Do not eat any more than 50mg of tyramine at any one meal.
>
> I would be very interested to know what drugs you would combine with moclobemide. Zyprexa would be interesting.
>
> I tried moclobemide in December, 1996. I reacted very, very badly to it. It exacerbated my depression to a degree worse than I have ever experienced. I was curled up in a fetal position on the couch for days, wimpering in pain. No thoughts. Just mental pain.
>
> Roche conducted trials of moclobemide in the US for the indication of social-phobia. I guess they figured they had a better chance of getting the FDA to approve a drug for an indication for which few drugs had yet been approved. The results were poor. I spoke to the head of the US moclobemide project just before it was discontinued. He told me that it was dead and that the trials had been terminated. I doubt they will revisit it.I was considering moclobemide precisely because it *is* weak. I hyper-respond to antidepressants, due to bipolar and to general med sensitivities. It wouldn't surprise me at all if I responded well to 75mg twice daily! You see I am only taking 12.5mg of Effexor and 18.75mg of Wellbutrin right now. Any more of either one of those disrupts my sleep too much, or makes me too tired or too wired during the day. The trouble I have with antidepressants isn't really response, it is tolerance and hypomania. Also, stimulants and short half-life AD's like Effexor seem to work better than longer-half life AD's. The longer half-life ones seem to cause a lot of early morning awakenings and resultant daytime drowsiness. When that happens a lot, my cycling tends to worsen.
>
> > Also, the active metabolite of nortriptyline (I think E-10 OH-nortriptyline),
>
> Isn't the parent compound active? What are the differences between them? What other drugs downregulate 5-HT receptors? In what ways does this help with depression? Is it simply an observed association or is there a hypothesis as to how it contributes to producing a remission?OH, I was just thinking out loud about a medline abstract I read regarding E-10 OH-NT a long time ago. They recommended looking into developing it as a possible antidepressant. The 5-HT downregulation is common with many antidepressants-I think they were primarily looking at the anxiolytic effects. Nortripytline (the parent compound) *is* active. NT just happens to be the only tricyclic that I have had any success with. Amitriptyline is it's parent. Another study was done where they gave AMI to a group of people and measured the relative balance of AMI and NT in their blood. The people that had the highest remission rates had the highest NT blood levels. How active E-10 OH-NT compared to *it's* parent we probably will never know.
>
> Thanks.
>
> > Why can't that be developed? Marketing active metabolits of older drugs is becoming more common (fexofenadine and cetirizine, ie.).
>
> For every 1 drug brought to market, 100 are synthesized, researched, and discarded for various reasons, including projected profitability. It costs 800 million dollars and 12 years to get a drug approved by the FDA. I imagine there are a few miracle drugs that have ended up in landfills.
>
>
> - Scott
>
>
Posted by pharmrep on August 15, 2002, at 13:19:25
In reply to Re: Interesting article » SLS, posted by Ritch on August 10, 2002, at 11:08:40
Hi all, check your news sites, Lexapro was approved today. There are plenty of studies and clinical information posted as well if you havent already found some. (should be in pharmacies 1st week of September)
Posted by Anyuser on August 15, 2002, at 18:45:44
In reply to Lexapro approved » Ritch, posted by pharmrep on August 15, 2002, at 13:19:25
> There are plenty of studies and clinical information posted as well if you havent already found some.
Any new studies and clinical info posted? By that I mean very recent. Could you provide links? Thanks.
Posted by johnj on August 15, 2002, at 22:07:41
In reply to Lexapro approved » Ritch, posted by pharmrep on August 15, 2002, at 13:19:25
Can you tell me why some people have sommolence and others have insomnia due to the drug? I want to try something different, but insomnia is part of my problem. Does the side effect/s slowly go away as one is acclimated to the drug? Thank you
johnj
Posted by Ritch on August 15, 2002, at 22:08:43
In reply to Lexapro approved » Ritch, posted by pharmrep on August 15, 2002, at 13:19:25
> Hi all, check your news sites, Lexapro was approved today. There are plenty of studies and clinical information posted as well if you havent already found some. (should be in pharmacies 1st week of September)
PharmRep,
Yes, I heard about that. I was on Celexa with other meds for a couple of years. Next pdoc appt. is next week though, so no likelihood of any samples available just yet. I am willing to give it a trial. I will be looking at how it differs from Celexa as far as GI problems go (reflux, heartburn, diarrhea). Celexa has been the worst med I have ever taken for reflux trouble (except for a couple of NSAIDS). I am especially sensitive to SSRI's for GI troubles. OTOH, I only ever needed about 2-5mg of Celexa/day (and not much of any other antidepressant for that matter), so I am looking at a trial of 1-2mg of Lexapro every day.
Mitch
Posted by pharmrep on August 15, 2002, at 23:24:36
In reply to Re: Lexapro approved » pharmrep, posted by Ritch on August 15, 2002, at 22:08:43
gi issues with celexa were mostly in first 8 wks (ie...nausea for cx=21%/placebo 14%) and seemed to drop to placebo-like in long term studies (6-24 mo's...ie nausea..cx=6%/placebo=10%) Of course everyone responds differently, but the side effect profile is promising. Your Celexa dose sounds very low, but again, you could be ultra-sensative. I do know the 10mg pill for Lex will be scored...it sounds like you can try 5mg (or 2.5 if you like to use razors)
Posted by pharmrep on August 15, 2002, at 23:35:25
In reply to Re: Lexapro approved » pharmrep, posted by johnj on August 15, 2002, at 22:07:41
> Can you tell me why some people have sommolence and others have insomnia due to the drug? I want to try something different, but insomnia is part of my problem. Does the side effect/s slowly go away as one is acclimated to the drug? Thank you
> johnjWeird things these mind altering drugs do. Some people respond getting tired, while others get a "lift." I can tell you this...the FDA is allowing this statement in the package insert...side effects and discontinuation due to adverse events are equal to placebo. That is huge...there is always the "placebo-effect" that kicks in when you "study" a drug. Anyway, I would think that lex will probably effect you like celexa did, but at a lesser degree, perhaps no effect, but probably not the opposite..ie..if you had insomnia, you wont now have somnolence...and yes, some s/e that occur in first few months sometimes fade away with time (ie for celexa nausea is higher than placebo at 8 wks, but less at 6 months)
Posted by pharmrep on August 15, 2002, at 23:41:35
In reply to Re: Lexapro approved, posted by Anyuser on August 15, 2002, at 18:45:44
http://biz.yahoo.com/prnews/020815/nyth063_1.html
here is one...I'm still learning this hyperlink thing..sorry if not done right
Posted by Anyuser on August 16, 2002, at 10:02:55
In reply to some Lexapro clinical info » Anyuser, posted by pharmrep on August 15, 2002, at 23:41:35
Posted by Phil on August 16, 2002, at 12:23:33
In reply to some Lexapro clinical info » Anyuser, posted by pharmrep on August 15, 2002, at 23:41:35
Posted by Phil on August 16, 2002, at 12:36:50
In reply to Re: sexual s/e Phil, posted by pharmrep on August 5, 2002, at 22:37:56
I had my T checked and it's above normal. Doesn't sound like good advice to start on shooting it once a month.
Thanks anyway.
Posted by pharmrep on August 17, 2002, at 1:52:49
In reply to Re: sexual s/e Phil » pharmrep, posted by Phil on August 16, 2002, at 12:36:50
i thought the same thing...but really, I dont think it is higher. 6% for celexa over 5 years ago from "volunteered" input was low (more like in teens or so...some other ssri's can get over 30%). Sexual s/e werent mentioned back then (pre-viagra...etc). With all the talk about sexual side effects and overall feelings about the topic now, people arent shy about it...so celexa at 6% and Lexapro at 9% isnt necessarily worse...in fact, since the studies are less than a year old...it is probably more accurate. (Even if a little higher, it wasnt bad enough for patients to discontinue...placebo dropout was 4%...Lexapro was 6%)
Posted by .tabitha. on August 17, 2002, at 15:35:49
In reply to Re: sexual s/e Phil » pharmrep, posted by Phil on August 16, 2002, at 12:36:50
Posted by dr. dave on August 19, 2002, at 4:52:24
In reply to Anyone switched to Lexapro? « ggrrl, posted by Dr. Bob on June 11, 2002, at 7:52:48
The Danish Institute for Rational Pharmacotherapy has reviewed all of the available data comparing Lexapro and Celexa and has concluded there is no convincing evidence for any difference in tolerability, efficacy, or anything else. This is the only other independent review of the data apart from Micromedex I am aware of. It is only those linked with the manufacturers of Lexapro that are talking it up, and the only two independent reviews come to the same conclusion - there is no real difference. The story is on the Reuters news website.
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