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.
poster:evenintherain
thread:943575
URL: http://www.dr-bob.org/babble/20100416/msgs/943575.html