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Home > Archive > Depression Medications > October 2005 > Much touted "MAOI patch" gets shot down by FDA
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Much touted "MAOI patch" gets shot down by FDA
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| I'm Rick James, bitch 2005-10-26, 11:34 am |
| The FDA has finally decided it will require a "black box" warning on
the EMSAM selegiline "MAOI patch." This black box warning will discuss
the possible dangers of consuming certain foods when on the MAOI patch.
This patch, which has been in development for years, has been touted by
its developers as a "breakthrough drug" for hard to treat depression.
It has been claimed by the developers of this med, that EMSAM would
allow a person to take a high dosage MAOI, but without the usual MAOI
diet required for oral MAOIs such as Nardil, Parnate and Marplan.
This link comes straight from the FDA:
http://www.fda.gov/ohrms/dockets/ac...0disclaimer.htm
This link discusses the FDA's desire to put a "black box" on the EMSAM
monograph regarding possible food interactions:
http://yahoo.reuters.com/financeQuo...bt004085_newsml
NOTE: I believed all along this would probably happen and I had dour
predictions for the "MAOI patch" from the beginning. I believe this
patch will prove no major advantages over traditional oral MAOIs for
severe, treatment resistant depression.
Somebody wasted a shitload of money developing this drug. But then this
is psychiatry for ya...so what the hell do you expect?
Eric
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| I'm Rick James, bitch 2005-10-26, 11:34 am |
| This is the best summarized version of this issue I have read so
far...its a MSNBC article about the black box warning.
http://msnbc.msn.com/id/9814075/
Eric
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| Larry Hoover 2005-10-26, 11:34 am |
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"I'm Rick James, XXXXX" <Deepsand562@aol.com> wrote in message
news:1130284147.120625.252420@g44g2000cwa.googlegroups.com...
> The FDA has finally decided it will require a "black box" warning on
> the EMSAM selegiline "MAOI patch."
No, it hasn't been decided yet.
The PDAC was meeting today, and one FDA staff member was arguing for a warning.
That's not the same thing as a final ruling, Eric.
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| I'm Rick James, bitch 2005-10-26, 11:34 am |
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Larry Hoover wrote:
> "I'm Rick James, XXXXX" <Deepsand562@aol.com> wrote in message
> news:1130284147.120625.252420@g44g2000cwa.googlegroups.com...
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>
> No, it hasn't been decided yet.
>
> The PDAC was meeting today, and one FDA staff member was arguing for a warning.
> That's not the same thing as a final ruling, Eric.
OK Larry, we shall see and wait for this "final ruling." I predict the
black box warning will be assigned by the FDA and this drug will be a
huge flop.
Eric
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