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From:
Kemp Randolph <[log in to unmask]>
Date:
Sat, 29 Jun 1996 18:47:49 GMT
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<<Disclaimer: Verify this information before applying it to your situation.>>
 
On Jun 28, 1996 20:34:11, 'Irma R DeBruyn <[log in to unmask]>' wrote:
 
>Today I had my pharmacist check to see if Vasotec, a medication
>used to lower blood pressure, was ... gluten free..... I was told that
>they generally used cornstach but their
>could be gluten. Most of her canned speech,
 
I just got done with Hoescht Marion Merrel Dow about the calcium blocker
Cardizem CR.  Fortunately I got past the canned speech and for now am using
this time release drug. Details follow some general conclusions.
 
These are both prescription drugs, so the FDA requires approval not just of
the ingredients but of the way they're packaged because that affects
delivery of the drug. Anything that affects the  drug dissolving then is
FDA liable. ANy changes have to go through likely lengthy FDA procedures
and may require different manufacturing details to get the right time
course. What you're hearing is probably legal double speak. As these
companies grow larger by merger, they try to set up a legal wall to protect
themselves. IMO  their concern with gluten is more likely contamination
from their suppliers than their switching to another kind of starch. They
know we complain about "any" gluten.
 
Perhaps I'm wrong on Merck -- ask if the FDA has approved all three
starches. Maybe the starch there isn't in the time release and hence they
have this freedom.
 
In Cardizem CR the  "starch" (way down on the ingredient list) is in the
little seeds that dissolve slowly --the main slowing agent, I suspect, is
probably the iron oxide at the top of this list.  I spoke to John Witike
(spelling is wrong) at 800-362-7466.
 
He first recited the (old) statement as still valid, that all Hoescht drugs
are gluten free. I questioned the starch He said corn and when I asked how
much for the 120 mg. dose he said he'd get back to me. He called back to
first say that they couldn't guarantee that their suppliers hadn't switched
the source of starch.   Turns out to be 60 mg. of starch  in that dose
size. Not very much daily if even a worst case dirty wheat starch.
Remember starch is carbohydrate, not gluten's protein category. Further he
was told by someone else this time that corn was in the FDA materials so
they couldn't switch it  because of its effect on release rate.  I don't
know whether  it's a major player there or  not.
 
For now I'm using this drug given the small amount of starch. My follow-up
is to get a written statement from Hoescht (was given that option when I
called) --if it has that nonsense about switching then I'll send that to
Felicia Satchell at the FDA, that marvelous consumer rep who was at the
Baltimore reading.
 
Anyone know of a drug who's "starch" is definitely not corn?  I suspect
there are none. Relative prices of wheat and corn starch?
 
                                     Kemp Randolph
                                     Long Island

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