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Re: I also know one of the founders of EMSAM

Posted by Honore on April 6, 2007, at 16:42:29

In reply to Re: I also know one of the founders of EMSAM » chiron, posted by UgottaHaveHope on April 6, 2007, at 16:16:27

Some of the information on which the FDA's decision to require food labeling and information with the 9 and 12 mg patches is at the following url. (I could only access the information with HTML; there is also a powerpoint presentation for those with powerpoint on their browers.)

http://209.85.165.104/search?q=cache:rDOF8C1kURoJ:www.fda.gov/OHRMS/DOCKETS/ac/05/slides/2005-4186S2_02_FDA-Dubitsky.ppt+emsam+tyramine+pressor+challenge&hl=en&ct=clnk&cd=1&gl=us&client=firefox-a

So far as I can see, there is significant evidence that both the 9 and 12 mg doses may not require such labeling. The main concerns are inter=individual differences in response to tyramine challenges, and intra-individual differences, both of which cover a substantial range, but the vast majority of which don't reach the level that would cause a hypertensive reactions.

This particular document seems to be an earlier decision by the FDA than the final one. This decision seems to have been reconsidered and changed, to allow no labeling for the 6 mg dose. This one required labeling for all doses-- on the theory, which it points out, incidentally, that there's very little difference among pressor responses to all doses. That can be read either way I suppose. (I couldn't access other documents, as I say, so the later presentation by Somerset may be accessible to others.)

Even on the 6 mg patch, there is a small chance that some individuals may have hypertensive reactions-- but, on the other hand, there's a large chance that only those individuals would have a hypertensive reaction to the 9 or 12 mg patch.

Honore


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