<<Disclaimer: Verify this information before applying it to your situation.>>
Thank you to all of you who wrote to me over my concerns about Zithromax.
As background, I had originally written to this list about the
cautionary statement I was given by Pfizer in trying to find out
whether or not Zithromax Z-Pak is GF. Pfizer's statement was: "May
contain .01-.05 non-gliadin gluten." They could offer me no
explanation of what was meant by that. One person had posted to this
list that Pfizer told her that Z-Pak is *not* GF, and that she had a
reaction to taking it. Another person posted that Pfizer gave her
the information that the gluten in Z-Pak is corn.
First, a summary of responses to my own post. The vast majority who
wrote believe that all "non-gliadin gluten" to be OK for people with
CD ... though it turns out that this is not true, as "gliadin" only
refers to wheat, and non-gliadin could be any other type of gluten,
even "offending" types for those with CD. Two people who wrote have
all their drugs compounded, because they can no longer get sufficient
answers about the GF status of many drugs. Quite a few said that
(like me) Zithromax is their last hold-out, having allergic reactions
to most other antibiotics. MANY wrote to say they use Z-Pak with no
problems at all. (Zithromax is obviously a widely-prescribed drug!)
Two said they had gluten-type reactions to Z-Pak. Some also wrote
that their doctors and pharmacists always check the "big book"
(PDR/Physician's Desk Reference) before ordering any drugs -- but (my
comment) the PDR is not guaranteed to be current, and drug companies
are not required to list anything but active ingredients in their
inserts or what ends up in the PDR. They are also not required to
list common allergens that might be part of the inactive ingredients
of a drug. (The FDA ruling for foods, requiring the disclosure of
allergens, does NOT apply to prescription medications, even though
both foods and drugs are governed by the FDA.)
With so little consensus, I inquired of an expert -- a doctor of
pharmacy, who was a speaker at a conference I attended last year. I
felt somewhat vindicated, in learning how many layers HE had to go
through to get an answer -- and even, at that, Pfizer still wouldn't
give an absolute statement of whether or not the product is GF.
However, the doctor feels confident that Z-Pak is almost certainly
GF, given his conversations with them.
Here is a summary of what the doctor told me:
-- Z-Pak is almost certain to be GF. Pfizer did tell him that the
known source of starch in this drug is corn. It is very improbable,
in a laboratory environment, for there to be cross-contamination from
other glutens. While Pfizer does not guarantee it to be GF, it
probably is. He also believes the suspension version is GF, even
though (again) Pfizer will not guarantee it.
-- The BEST news of all: generic for Z-Pak (made by Teva, not by
Pfizer) is absolutely GF. (One list member gave me this information,
and it was confirmed by the doctor.)
-- "Non-gliadin gluten" refers to any gluten that is not wheat, and
could be any other starch, even offending ones, such as barley or
rye. However, barley and rye (and oats) are not known, in general,
to be used in pharmacology ... with corn, potato, wheat and tapioca
being the primary starches. Thus, if "non-gliadin" gluten is used to
describe a drug's ingredients, it MOST likely is not a problem for
anyone with CD. (But in the big world out there, "non-gliadin" could
be problematic, when it comes to foods.)
-- Zithromax, as well as many other antibiotics, stimulates bowel
motility, OFTEN causing diarrhea. Many people mistake this for a
reaction to gluten. When taking any antibiotic, his recommendation
is to also take Culturelle <http://www.culturelle.com> to repopulate
the good bacteria in the gut. He says is it an excellent product,
does not require refrigeration and is available without prescription
at many drugstores.
-- The reason that large drug companies often will not make any kind
of guarantee about the "GF-ness" of their products is for liability
and legal reasons. They out-source many of their drugs, so they are
not in control of the labs where they are made. Also, they often buy
up drugs from other companies, and are not able to guarantee the
resources of all these drugs first-hand, and can only go by what the
former drug company provides in terms of information. Smaller
companies (such as Teva, which makes the generic for Z-Pak) have more
control, and often produce all the drugs themselves, so they feel
confident in making statements about GF. Nearly all prescription
drugs are GF -- but getting a manufacturer to guarantee it these days
is close to impossible. It is still important to call and check,
however, and get the best answer you can. Press for specific
information about the source of any STARCH used in the drug, and you
will likely get your answer.
~~~~~~~~~~~
SO -- for me, I'd probably be comfortable with taking Z-Pak, but will
most likely be VERY happy to save money and get the generic version,
which is definitely GF. Hope this helps to resolve most of the
controversy!
Visit the Celiac Web Page at Http://www.enabling.org/ia/celiac/index.html
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