From:
Pam Sessoms
Date: 2010-01-05 20:32:12 UTC
Subject: Re: [ferrethealth] Re: Need Help Finding...
To: ferrethealth@yahoogroups.com
On Tue, Jan 5, 2010 at 2:17 PM, manajane21 <amandadegraw@hotmail.com> wrote:
> You are correct in that kaopectate contains SA. I honestly don't
> know why the formulation changed.
According to the following, the formulation was changed because of FDA
doubts about its efficacy:
http://www.fda.gov/downloads/Drugs/DrugSafety/MedicationErrors/UCM080666.pdf
"The FDA found attapulgite efficacy data to be inadequate and, thus,
attapulgite was not included as a monograph ingredient in the April
17, 2003, final rule."
The primary source is the US Federal Register (the text for the
relevant part starts over on the right-most column):
http://edocket.access.gpo.gov/2003/pdf/03-9380.pdf
Antidiarrheal Drug Products for Overthe-Counter Human Use; Final Monograph
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 310, 335, and 369
In the end, I guess the company changed the formulation in the US
because they were required to by law. They still produce the original
formula for other countries.
(hopefully this isn't too off-topic)
Best wishes to all,
-Pam S.
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