![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 7 of 7. This is the beginning of the thread.
Posted by evenintherain on April 16, 2010, at 13:28:05
I have read a lot on here about Amisulpride, and how it is used in many countries in low doses (50mg or so) to treat depression and dysthemia. Some say it is helpful in promoting motivation and helping with anhedonia.
My question is, why is it not FDA approved in the US? I understand that getting FDA approval can be very costly. But there is a clear market for pretty much all anti-depressant drugs, isn't there? Is cost the only reason?
It looks like amisulpride tends to have fewer side effects than others in its class, with the main issue being increased production of prolactin. This is not good for males or females, but as I'm a female, I am interested in this quote (from this post: http://www.dr-bob.org/babble/20010515/msgs/63723.html):
"about 50% of women will experience loss of menses, disrupted menses or breast swelling because of this. One case study showed that use of bromocriptine (which lowers prolactin) would remove these side effects without diminishing the effect of sulpiride (a drug very much analogous to amisulpride). Women who benefit from amisulpride but have these side effects should seriously consider taking bromocriptine as an add-on."
Though changes in menses and breast swelling are frequent side effects of birth control and most women are willing to put up w/that, I have to admit this info sort of turns me off. This may just be because of my lack of knowledge (I don't understand if extra prolactin is dangerous in any way in the long term).
That old post (it was from 2001) predicted FDA approval w/in two years, clearly that hasn't happened. It's not a new drug, so I'd really like to know if there's a reason (other than financial/lack of interest) it is not available to us in the US (yes, i know we can order online).
I'm wondering if part of the reason this drug is looking so appealing to me is it's unattainably and minimal anecdotal evidence (for every positive story about response to any given psychopharmaceutical there seem to be 10 negative one). Maybe this is giving me false hope (though I am still skeptical)? Maybe there is a good (health) reason it is not FDA approved? Probably not, but I'd appreciate any info you have on this.
I've been doing a lot of research on hypothetical treatments for my current anhedonia and lifelong depression (I'm not finding my doctors helpful at the moment), and this is one of those drugs that keeps coming up.
Posted by SLS on April 16, 2010, at 14:55:32
In reply to Amisulpride - Why isn't it FDA approved?, posted by evenintherain on April 16, 2010, at 13:28:05
> Maybe there is a good (health) reason it is not FDA approved?
The patent has probably expired.
- Scott
Posted by linkadge on April 16, 2010, at 16:08:19
In reply to Re: Amisulpride - Why isn't it FDA approved?, posted by SLS on April 16, 2010, at 14:55:32
A side note. Some researchers suggest that the antidepressant effect of amisulpride has nothing to do with its dopamine receptor activation. Instead, they suggest that the mechanism is 5-ht7 antagonism.
http://www.biopsychiatry.com/amisulpride-5ht7antagonist.htm
Linkadge
Posted by ed_uk2010 on April 16, 2010, at 16:19:17
In reply to Re: Amisulpride - Why isn't it FDA approved?, posted by SLS on April 16, 2010, at 14:55:32
> > Maybe there is a good (health) reason it is not FDA approved?
>
> The patent has probably expired.It has been available as a generic in the UK for quite some time.
Posted by evenintherain on April 16, 2010, at 16:26:55
In reply to Re: Amisulpride - Why isn't it FDA approved?, posted by linkadge on April 16, 2010, at 16:08:19
Thanks for the responses.
And for the article, Linkadge.Have tried to school myself a bit on the neurotransmitters enough to parse through some of these articles the past few days, but think i've come to the conclusion that:
1) neurotransmitters are confusing
2) who knows how they work
3) my neurotransmitters do not allow for the focus and concentration necessary for this sort of research
4) seriously, they make no sense!it's not enough that i have to question the reliability of all these sources but i also have to question the human's capacity for understanding the brain (so far. here's to the future).
much respect to those of you who can comprehend the stuff.
Posted by bleauberry on April 17, 2010, at 10:58:21
In reply to Amisulpride - Why isn't it FDA approved?, posted by evenintherain on April 16, 2010, at 13:28:05
Others have already answered your question. It is too expensive a process to pass the FDA hurdles, and the drug is old enough that it can be made generic. Nobody is going to spend those millions of dollars to market a generic.
I wish new laws would be written to allow foreign drugs to become available in the USA pharmacies without going through the customary FDA process of newly developed drugs that do not have a track record. Some of the qualifying factors could be:
1. A track record of at least 10 years.
2. Widely prescribed.
3. As safe or safer than its USA counterparts.
4. A good body of scientific evidence.
5. Proven efficacy equal to or greater than its USA counterparts.The FDA serves a good purpose. But I believe their immense size, politics, and inner ego would prevent any thought of even acknowledging that other drugs around the world would benefit Americans in a big way.
Posted by conundrum on April 18, 2010, at 7:28:23
In reply to Re: Amisulpride - Why isn't it FDA approved?, posted by bleauberry on April 17, 2010, at 10:58:21
Not to get to political but it seems like most Americans refuse to admit that any other nations have better ideas or do anything better than we do.
<sarcasm>
We are the greatest country in the world after all.
</sarcasm.>
This is the end of the thread.
Psycho-Babble Medication | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.org
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.