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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 25 of 38. This is the beginning of the thread.
Posted by McPac on June 19, 2003, at 2:27:41
Been reading a lot about Reboxetine. Sounds VERY good. I suppose THAT is the reason that the pharmaceutical company-controlled FDA declined it's U.S. approval (I read that NO reason was given why).....puleeeeeze! translation, it wasn't approved because many ssri patients would have switched! These pharm. co's will protect their turf and do whatever they can to keep better drugs being approved. Everything I read, in many abstracts, point to Reboxetine being at least as good and even better for severe depression and having much less side effects than ssri's like Prozac. Block the better drug from approval and keep this crummy ssri monopoly going, what a joke. (1 abstract below; read MANY that were similar):
Clinical efficacy of reboxetine
in major depressionSchatzberg AF
Department of Psychiatry and Behavioral Sciences,
Stanford University School of Medicine,
Calif 94305-5717, USA.
J Clin Psychiatry 2000; 61 Suppl 10:31-8ABSTRACT
The past decade has witnessed the advent of selective serotonin reuptake inhibitors (SSRIs) as first-line treatments for major depression. Still, there is considerable debate as to whether these agents are as effective or as potent as the first-generation tricyclic antidepressants (TCAs) or the mixed reuptake inhibitor, venlafaxine, all of which exert considerable effect on norepinephrine (NE) reuptake. Recently, reboxetine, a selective NE reuptake inhibitor (selective NRI), has been introduced in Europe. This drug has only a minimal affinity for muscarinic acetylcholine receptors and therefore causes less dry mouth, constipation, or other such effects than do the TCAs. Reboxetine does not block serotonin reuptake or alpha1 receptors and, thus, does not appear to produce significant nausea, diarrhea, or hypotension. Unlike other antidepressants, reboxetine appears to be nonsedating. Data on acute and long-term clinical efficacy and safety from double-blind, placebo-controlled, and active comparator studies with reboxetine are reviewed. These studies indicate that reboxetine is significantly more effective than placebo and as effective as fluoxetine in reducing depressive symptoms. Improvements in social adjustments were reported to be more favorable with reboxetine than with fluoxetine. Further, data from controlled clinical trials have shown that the side effect profile for reboxetine is relatively benign. The clinical implications of studies on reboxetine are discussed with an eye toward understanding the potential role NE reuptake blockers may play in the treatment of patients with major depression.
Posted by turalizz on June 19, 2003, at 7:14:05
In reply to Reboxetine (not approved in U.S.? FDA blows!), posted by McPac on June 19, 2003, at 2:27:41
There are serious studies showing that reboxetine is very effective in controlling panic attacks.
From my own experience, I can say that it's the single most effective med I've found that helps my occasional, severe anxiety attacks.
It works better than benzos and SSRI's, and it is non-addictive and non-sedative. Why would Lilly want anything like that in the market???
Posted by McPac on June 19, 2003, at 10:52:21
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!), posted by turalizz on June 19, 2003, at 7:14:05
"Why would Lilly want anything like that in the market???"
>>>>>>>EXACTLY!!!!!!!!!!!!
Posted by McPac on June 19, 2003, at 10:54:04
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!), posted by turalizz on June 19, 2003, at 7:14:05
tura, but how can you get it if not approved in US (are you outside of US?)
Posted by Snoozy on June 19, 2003, at 10:58:28
In reply to Reboxetine (not approved in U.S.? FDA blows!), posted by McPac on June 19, 2003, at 2:27:41
Ugghh - tell me about it! I have had this article from Time magazine (Time - can you get a more mainstream publication than that?) from September 1997 on depression and neurotransmitters.
"Already psychiatrists are buzzing with news of reboxetine, which totally ignores serotonin and goes after norepinephrine, the neurotransmitter Prozac left behind. Approved in England just this past summer, it works quickly, has relatively mild side effects (constipation, dry mouth, low blood pressure) and might eventually be the therapy of choice for people with especially severe depression."
I had the impression that it would be on the market soon after I read this article, and I've been waiting. Looks like I'll be waiting a looong time. It's different from what's already on the market, not just a variation on the same-old, same-old. I had hope it might help me as I have not had good results with SSRI's. (The area pdoc that does nothing but drug research studies was doing a test of reboxetine in 1998-99, but I couldn't get in). Maybe it wouldn't do anything for me, but I'd like the chance to find out.
I would really love to know what the story is - is it opposition from other drug companies or what? It doesn't seem like the FDA has been overly cautious of late and it sounds like a pretty safe drug. Makes one wonder. I don't get this 'let's spend millions of dollars to get FDA approval to market Paxil or Zoloft for this condition'. My understanding of that is that they're simply going through hoops so they can put out ads on tv and in print and say 'this drug is a treatment for social anxiety disorder' or what have you. I heard something about Paxil trying to get approval to market it for hot flashes. Is it me or does something seem wrong with this situation?
Of course, it probably won't be long before all of the big drug companies merge into one entity. Then they can advertise with the one media conglomerate we'll have :)
> Been reading a lot about Reboxetine. Sounds VERY good. I suppose THAT is the reason that the pharmaceutical company-controlled FDA declined it's U.S. approval (I read that NO reason was given why).....puleeeeeze! translation, it wasn't approved because many ssri patients would have switched! These pharm. co's will protect their turf and do whatever they can to keep better drugs being approved. Everything I read, in many abstracts, point to Reboxetine being at least as good and even better for severe depression and having much less side effects than ssri's like Prozac. Block the better drug from approval and keep this crummy ssri monopoly going, what a joke. (1 abstract below; read MANY that were similar):
>
Posted by McPac on June 19, 2003, at 11:11:39
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!), posted by Snoozy on June 19, 2003, at 10:58:28
"Already psychiatrists are buzzing with news of reboxetine, which totally ignores serotonin and goes after norepinephrine"
>>>>>>>Isn't increased norepin. bad for ocd though?
Posted by Barbara Cat on June 19, 2003, at 11:58:25
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!), posted by McPac on June 19, 2003, at 11:11:39
> "Already psychiatrists are buzzing with news of reboxetine, which totally ignores serotonin and goes after norepinephrine"
>
> >>>>>>>Isn't increased norepin. bad for ocd though?Exactly my thought, although everything I've read on it looks intrigueing. I thought NE made anxiety worse, triggered hypomania, was involved in the fight/flight cortisol response, was excitatory. Something else is going on with these meds besides the obvious neurotransmitter model.
Posted by Caleb462 on June 19, 2003, at 12:04:23
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!) » McPac, posted by Barbara Cat on June 19, 2003, at 11:58:25
> > "Already psychiatrists are buzzing with news of reboxetine, which totally ignores serotonin and goes after norepinephrine"
> >
> > >>>>>>>Isn't increased norepin. bad for ocd though?
>
> Exactly my thought, although everything I've read on it looks intrigueing. I thought NE made anxiety worse, triggered hypomania, was involved in the fight/flight cortisol response, was excitatory. Something else is going on with these meds besides the obvious neurotransmitter model.
>
>Well, yes.. that is the ACUTE reaction to increased norepinephrine. And in the first few weeks of treatment with Reboxetine, one might experienced increased anxiety. However... the adrenergic system downregulates in response to this increased NE... and after a few weeks, overall stress is DECREASED. That is the theory, anyway.
Posted by Jack Smith on June 19, 2003, at 12:10:22
In reply to Reboxetine (not approved in U.S.? FDA blows!), posted by McPac on June 19, 2003, at 2:27:41
> Been reading a lot about Reboxetine. Sounds VERY good. I suppose THAT is the reason that the pharmaceutical company-controlled FDA declined it's U.S. approval (I read that NO reason was given why).....puleeeeeze! translation, it wasn't approved because many ssri patients would have switched! These pharm. co's will protect their turf and do whatever they can to keep better drugs being approved.
I understand your frustration with the FDA but these ssri conspiracy theories are really not plausible. Reboxetine is owned by Pharmacia, which is a pharmaceutical company. So, the "pharmaceutical company controlled FDA" in your theory is also controlled by Pharmacia. Pharmacia gets a lot of drugs approved, ie xanax, so why do you think that Pharmacia, a pharmaceutical company, would not want its own drug approved????
Anyway, Straterra is the same type of drug as Reboxetine, a NARI. Try that if you want to try reboxetine.
JACK
Posted by Jack Smith on June 19, 2003, at 12:13:48
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!), posted by turalizz on June 19, 2003, at 7:14:05
> Why would Lilly want anything like that in the market???
That's right, Lilly controls the FDA. That is how four other SSRI's got approved by the FDA. That is why Zoloft (pfizer) is the top selling ssri. That is why Lilly lost its lawsuit to keep its patent on prozac. That is why duloxetine (a Lilly SNRI) is still not approved.
The pharmaceutical companies are the cause of all of our problems.
JACK
Posted by McPac on June 19, 2003, at 12:17:26
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!), posted by Caleb462 on June 19, 2003, at 12:04:23
"Well, yes.. that is the ACUTE reaction to increased norepinephrine. And in the first few weeks of treatment with Reboxetine, one might experienced increased anxiety. However... the adrenergic system downregulates in response to this increased NE... and after a few weeks, overall stress is DECREASED. That is the theory, anyway".
>>>>>>>>>>>Caleb, but are increased norepin. drugs supposed/recommended to be avoided by most ocd'ers? Are they effective for ocd? Thanks in advance for your reply!!
Posted by Caleb462 on June 19, 2003, at 12:35:15
In reply to Caleb, (not approved in U.S.? FDA blows!), posted by McPac on June 19, 2003, at 12:17:26
> "Well, yes.. that is the ACUTE reaction to increased norepinephrine. And in the first few weeks of treatment with Reboxetine, one might experienced increased anxiety. However... the adrenergic system downregulates in response to this increased NE... and after a few weeks, overall stress is DECREASED. That is the theory, anyway".
>
> >>>>>>>>>>>Caleb, but are increased norepin. drugs supposed/recommended to be avoided by most ocd'ers? Are they effective for ocd? Thanks in advance for your reply!!Well... I suppose that would depend on who you asked. In general, though.. I would say no.. norepinephrine meds do not need to be all out avoided by OCD patients. A selective norepinephrine med will not help OCD... but it may decrease OCD-related stress. As for reducing obsessions/compulsions, selective NRIs are quite ineffective.
Personally, as a GAD/OCD sufferer.. I tried to avoid things that will trigger the "fight or flight" response... rarely drink coffee, for instance.
However.. there is no hard and fast rule that OCD patients need avoid noradrenergic chemicals. For instance, the metabolite of Anafranil - desmethylclomipramine, is a potent inhibitor of norepinephrine reuptake.
Posted by McPac on June 19, 2003, at 13:15:35
In reply to Lilly controls the FDA--NOT, posted by Jack Smith on June 19, 2003, at 12:13:48
"The pharmaceutical companies are the cause of all of our problems."
No they're not.
Posted by stjames on June 19, 2003, at 13:17:31
In reply to Lilly controls the FDA--NOT, posted by Jack Smith on June 19, 2003, at 12:13:48
>
> The pharmaceutical companies are the cause of all of our problems.
>
> JACK
Gee, that is a sweeping generalization !
Posted by McPac on June 19, 2003, at 13:25:31
In reply to SSRI conspiracies--nonexistent., posted by Jack Smith on June 19, 2003, at 12:10:22
The fda is the pharm. co's puppet...not ONE single pharm. co. can control the fda because so many pharm. co's have huge power, when you have MANY co's with huge clout and power no single one will always get their way, but they as a group pull the fda's strings
Posted by McPac on June 19, 2003, at 13:38:33
In reply to Re: Caleb, (not approved in U.S.? FDA blows!), posted by Caleb462 on June 19, 2003, at 12:35:15
"As for reducing obsessions/compulsions, selective NRIs are quite ineffective".
"the metabolite of Anafranil - desmethylclomipramine, is a potent inhibitor of norepinephrine reuptake".
>>>>>>>>>>>>>>> How can the 2nd statement be true IF the 1st one is true too? (Is it because Anafranil also has SRI properties?) Thanks!!
Posted by McPac on June 19, 2003, at 14:52:25
In reply to SSRI conspiracies--nonexistent., posted by Jack Smith on June 19, 2003, at 12:10:22
http://www.zoloft-side-effects-lawyer.com/default.htm
No pharmaceutical company would EVER try to keep these side effects from being well-known would they,lol, they don't BOMBARD you with the "happy,pleasant" info and commercials and try to dismiss this stuff, why don't they use some of the school-shooters on ssri's in their commercials, lol, show all those dudes during their shooting rampages pausing to plug their ssri's, lol, those pharm. co's could probably teach the tobacco co's a few tricks,lol,...politicians are never crooked either! I'm not anti-Zoloft, just showing that it and the ssri's and the pharm. co's have another side as well, it works great for me in some ways, but there is another side for some, not as simple as "then don't take it", what if you have a problem where not taking it is even worse, then you pick your "poison", i.e. take this and suffer or don't take it and suffer, not much of a choice, Zoloft has been great for me for ocd/depression but ohhhhhh those extreme side effects, it works great for my niece too (without side effects) and anything that keeps that precious little squirt feeling better definitely cannot be all bad, gotta run, take care all!!!
Posted by Caleb462 on June 19, 2003, at 15:00:30
In reply to Caleb, (not approved in U.S.? FDA blows!), posted by McPac on June 19, 2003, at 13:38:33
> "As for reducing obsessions/compulsions, selective NRIs are quite ineffective".
>
> "the metabolite of Anafranil - desmethylclomipramine, is a potent inhibitor of norepinephrine reuptake".
>
> >>>>>>>>>>>>>>> How can the 2nd statement be true IF the 1st one is true too? (Is it because Anafranil also has SRI properties?) Thanks!!
>Exactly... clomipramine (anafranil) is a highly potent SRI... the metabolite desmethylclomipramine being the highly potent NRI
Posted by Jack Smith on June 19, 2003, at 15:51:09
In reply to Re: Lilly controls the FDA--NOT, posted by stjames on June 19, 2003, at 13:17:31
> >
> > The pharmaceutical companies are the cause of all of our problems.
> >
> > JACK
>
>
> Gee, that is a sweeping generalization !
>Sarcasm. Read the post in full and what it is in response to.
Posted by Jack Smith on June 19, 2003, at 15:55:23
In reply to Re: SSRI conspiracies--nonexistent., posted by McPac on June 19, 2003, at 13:25:31
> The fda is the pharm. co's puppet...not ONE single pharm. co. can control the fda because so many pharm. co's have huge power, when you have MANY co's with huge clout and power no single one will always get their way, but they as a group pull the fda's strings
Reboxetine was probably not approved because it was not that effective. Note that Lilly did not attempt to get straterra approved for depression probably because they knew that it was not effective enough. Norepinephrine only agents have proven less effective for depression.
Check through the archives of this site and you will see that reboxetine did not exactly get reviewed well here.
JACK
Posted by Snoozy on June 19, 2003, at 16:46:56
In reply to Re: SSRI conspiracies--nonexistent., posted by Jack Smith on June 19, 2003, at 15:55:23
I'm wondering if the FDA has guidelines on how effective a drug must be to get approval. If there were no or few other drugs on the market to treat a specific condition, would they approve something that had a lower efficacy rating as opposed to a proposed drug for which there are many alternatives available?
I'm also wondering what, if any, type of political appointments (other than commissioner) are made there.
> Reboxetine was probably not approved because it was not that effective. Note that Lilly did not attempt to get straterra approved for depression probably because they knew that it was not effective enough. Norepinephrine only agents have proven less effective for depression.
>
> Check through the archives of this site and you will see that reboxetine did not exactly get reviewed well here.
>
> JACK
Posted by turalizz on June 19, 2003, at 17:19:36
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!), posted by McPac on June 19, 2003, at 10:54:04
> tura, but how can you get it if not approved in US (are you outside of US?)
Yes I am. (Outside US I mean)
Posted by NikkiT2 on June 19, 2003, at 17:25:26
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!), posted by Caleb462 on June 19, 2003, at 12:04:23
I tried reboxatine a good couple of years ago (so its been lisenced in UK alot longer than this past summer) and only lasted 3 weeks.. and for the three weeks I was on it, I cried and cried and cried the whole time.. and I am not someone who cries easily..
Nikki
Posted by Caleb462 on June 19, 2003, at 18:31:20
In reply to Re: SSRI conspiracies--nonexistent., posted by Jack Smith on June 19, 2003, at 15:55:23
> > The fda is the pharm. co's puppet...not ONE single pharm. co. can control the fda because so many pharm. co's have huge power, when you have MANY co's with huge clout and power no single one will always get their way, but they as a group pull the fda's strings
>
> Reboxetine was probably not approved because it was not that effective. Note that Lilly did not attempt to get straterra approved for depression probably because they knew that it was not effective enough. Norepinephrine only agents have proven less effective for depression.
>
> Check through the archives of this site and you will see that reboxetine did not exactly get reviewed well here.
>
> JACKTrue, but what about nortryptiline and desipramine? Aren't these approved and considered effective for depression. And isn't imipramine's main mode of action norepinephrine reuptake inhibition (over serotonin uptake inhibition, that is). These are mainly noradrenergic agents, although I may be mistaken.
Posted by turalizz on June 19, 2003, at 19:27:15
In reply to Re: Reboxetine (not approved in U.S.? FDA blows!), posted by NikkiT2 on June 19, 2003, at 17:25:26
> I tried reboxatine a good couple of years ago (so its been lisenced in UK alot longer than this past summer) and only lasted 3 weeks.. and for the three weeks I was on it, I cried and cried and cried the whole time.. and I am not someone who cries easily..
>
> NikkiSee, that's what reboxetine does. It somehow seems to "intensify" the emotions. I became very emotional myself when I was on reboxetine.
But remember that apathy is a synptom of depression, and SSRI's are no good for that.Don't forget that depression is not like flue, symptoms change from person to person.
So why leave out something that can be useful to many patients?
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