<<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!

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