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Subject:
From:
"Lisa Marasco, IBCLC" <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Tue, 3 Jun 1997 13:06:49 -0400
Content-Type:
text/plain
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To Star and all else,
When I wrote that I would provide references, I was not referring to
official published research per se, but rather to the Red Book, and also
to the MDs on our list who work with diflucan and have experience in the
issue of necessary therapeutic dosages for nursing moms.  Shirley Gross,
Anne Eglash and Anne Norton-Krawciw have all posted their protocols and
experience, and I would cite their experience and ask our MD to consider
contacting them if it was still an issue.  I did not mean to be
misleading regarding published research, nor do I want the physicians in
my community to think that I've made up these recommendations on my own!

But, since you've brought up the point, I feel compelled to investigate
this all a little further. To that end, I called Roerig Pfizer and talked
with two of their reps about all of this. I would like to report my
findings to lactnetters, and enlist your help to break this issue free
for all of us.

First of all, though I was inquiring about the usage of diflucan for
ductal yeast, it was quickly stated to me that diflucan is
"contraindicated" for breastfeeding mothers, and they cited the now
famous case-of-one test on a 29yr old mom who took the 150mg one shot
therapy for vaginitis. I responded to the rep that diflucan is now
approved for pediatric usage, but she was still compelled to repeat the
official company line, which I then wanted to challenge. So, I was sent
up the ladder to a pharmacist for the company, and after wading through
the legal issues, I was able to ascertain that she realized that their
statement was based on lack of FDA review for this usage, NOT on a
history of problems. She quickly agreed with me that the way they now
phrase their statement on the phone implies a history of problems
_"contraindicated"_  and I suggested that they reword their statement to
something more along the lines of "diflucan has not been reviewed for
this particular application by the FDA, and therefore is not officially
sanctioned", etc. etc.   The pharmacist mentioned that if we had
published case reports, it would help immeasurably, and I pointed out to
her that if they continue to respond to inquiries with "contraindicated",
that it is unlikely that there will be many case reports to study, having
scared all the docs off!   Our discussion went on to affirm the excellent
safety profile of diflucan in all populations, and the relatively small
risks, especially when the alternative is artificial baby milk for baby.

In pursuit of the question of proper treatment of ductal yeast,
disregarding the issues of safety during breastfeeding, I questioned the
pharmacist on whether she would categorize ductal yeast as "systemic".
After a slight pause for thought, she said yes, she would consider this a
systemic problem. I told her that my point in asking this question was to
ascertain if there was sufficient reason to warrant the application of
official recommendations of diflucan for systemic treatment-- 7-10 days,
and she felt that there is sufficient reason.  In fact, she reiterated
that it should probably be treated with the same protocol as is applied
for oral candida-- 7-10 days. Thus, in terms of validating the need for
long term vs one shot therapy of ductal yeast, the pharmacist for the
company was in agreement with "our" analysis of the situation, that
ductal yeast would best be treated with longer term dosing.

My final point with her was to encourage the company to do clinical tests
that would officially validate the usage of diflucan in breastfeeding
mothers and establish dosing protocol. I pointed out to her that we
really don't have tx alternatives other than Nizoral, which is not as
"safe"; that with increased prophylactic antibiotic usage the ductal
yeast rates are rising; and that the only alternative in cases that do
not spontaneously resolve is to recommend weaning, which, considering the
true risks involved, is rather ridiculous [she agreed].  I also pointed
out that her company wants to make money, and studying this drug for
breastfeeding mothers would most likely result in greater sales for the
company--- the appeal of the almighty dollar, the basis of American
capitalism!  She suggested that I -- or we--- contact the PhD who is in
charge of clinical trials to make our request known.  Perhaps if we all
voice the request that this company pursue approval of diflucan for use
in breastfeeding mothers, the company will consider taking this on
officially.  Here is the person whom we need to address our concerns:

Helene Panzer, PhD
Pfizer Inc
235 E. 42nd St, 14th floor
New York, New York 10017

I would especially love to see the MDs on our list make this suggestion,
and also share their experience with Ms. Panzer.  I don't see the yeast
issue abating anytime soon given the current obstetrical climate; let's
be proactive!  And as of right now, though we have our own good sources,
I would hate to have an MD contact Roerig to try to validate what we are
saying, as Roerig Pfizer's current approach is CYA rather than bfg
friendly.

It was also suggested to me that if there are published case studies
using diflucan, that we need to bring these to the company's attention
(probably to Ms. Panzer) so that they can be incorporated into the data
base and made available to the reps who say those lovely things like
"contraindicated" and "no other information".

-Lisa Marasco, BA, IBCLC
      Santa Maria, CA

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