CELIAC Archives

Celiac/Coeliac Wheat/Gluten-Free List

CELIAC@LISTSERV.ICORS.ORG

Options: Use Forum View

Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
Kemp Randolph <[log in to unmask]>
Date:
Wed, 17 Jul 1996 22:09:38 GMT
Content-Type:
text/plain
Parts/Attachments:
text/plain (59 lines)
<<Disclaimer: Verify this information before applying it to your situation.>>
 
See the earlier posts on Vasotec and/ or Merck. My post of June 29
discusses the starch in Cardizem.
 
I got a call back from Hoescht Marion Merrill Dow (800-362-7466, John
Wokte) about the gluten status of Cardizem CD, the time release form of
this calcium blocker. I should be getting this in writing. I didn't push on
thecorn/ wheat options for the starch this time but suspect that may show
up in what they put in writing.
 
Because of the FDA's control over the ingredients in prescription drugs,
you can actually find out something about starch content. Details follow,
but for me it looks like there's so little (carbohydrate) starch in the 180
mg dose capsules I take that, even if the protein impurity in that starch
were all a toxic gluten, then the amount is so much smaller than any daily
amount shown to cause damage in biopsed celiacs. (I can't rule out the
possibility that some people may have a "Type I hypersensitivity reaction"
(IgE) to gluten with the short term vomiting or diarrhea but I doubt celiac
damage.)
 
Starch in cardizem CD (180 mg. dose): ingredient list (Physician's Desk
Reference): 11 listed in order of decreasing amounts with sucrose 7th
followed by starch  8th.  There's 60 mg of sucrose in these pills. It's
present as the core of the time release seeds --the 180 mg of drug is
coated on all these tiny cores and starch is used as a binding agent in
this coating.  The amount of starch is actually much less than the 60 mg.
of its list neighbor sucrose. Whether down by 10 or even more I didn't
bother to find out due to the following.
 
100 mg. toxic gluten/day for a month has been shown to cause some
intestinal damage in Catassi et al (study used controls, as I recall).  How
much might be in (worst case) 60 mg of wheat starch?
 
Starch is made by washing out the protein part of the grain flour. The
protein portion of wheat is roughly 10% so 6 mg. here. Even if the washing
process only gets 90% of the protein out that leaves just  0.6 mg of wheat
protein  (Washing used to meet celiac standard abroad must be much better
than this because daily consumption of starch  is likely hundreds of grams,
100 or more as much.) Again, for worst case say it's all toxic.
 
(Don Kasarda may be able to refine these wheat numbers, indeed even lower
them significantly. I can also lower the original worst case 60 mg. amount
by calling Hoescht again.)
 
But can someone show us a study that even an overestimated 0.6 mg. of toxic
gluten a day had a measurable effect on celiacs?
 
In the meantime, while waiting the letter from Hoescht that may clarify
their ability to switch wheat starch for corn starch, I'll continue  taking
the Cardizem.
 
The Vasotec situation may involve much more starch. If it does and they
stll claim the wheat substitution ability, get it in writng and contact the
FDA.
 
                                             Kemp Randolph
                                             Long Island

ATOM RSS1 RSS2