I don't know if this will answer your question,
Kathleen. But it does give a different POV.
I have a family member who checks the FDA website
frequently, because his job involves quality assurance
of medical diagnostics. Basically, he helps companies
stay in compliance with FDA regulations, and assists
them in responding if they get a warning letter.
When he saw the domperidone warning on the FDA
website, he sent it to me, knowing that I would be
interested. I responded by telling him of some of the
info I had seen and heard on the web regarding
domperidone (for example, Thomas Hale's response).
I also mentioned that I had seen the following
statement at Jack Newman's website: "The United States
Food and Drug Administration has issued a warning
concerning domperidone. Coincidentally, the warning
was issued on the opening day of the United States
National Breastfeeding Campaign."
This is what my relative had to say in his return
email, in part:
"I don't think that it is "politics" because even one
Warning Letter (let alone 5) is a very serious
business, and I can assure you that no drug (or
formula?) company wants to receive one for "political"
(or for any other) reasons.
The Letters concern distribution of several unapproved
drugs, so it is clear that they are not targeted at
domperidone but are part of FDA's continuous and
statutory responsibility to police unapproved drugs in
interstate commerce. Finally, I doubt that anyone at
FDA even knew about the start date of the 'Campaign.'
"
I went to the FDA website, after receiving this email,
and did note that none of the 5 letters were sent to
drug companies; 4 were to pharmacies that have been
compounding domperidone, and one was to a drug
distribution company.
Just offering this as something more to think about,
with respect to domperidone and the FDA warning.
Judie Gibel
Florida
> Date: Mon, 14 Jun 2004 23:43:20 -0400
> From: Kathleen Bruce <[log in to unmask]>
> Subject: Domeridone
>
> Dear all, I have been reading and re reading the
> notes on Domperidone,
> regarding the recent FDA statement warning against
> the use of
> Domperidone.
>
> As a very busy on-line IBCLC, I have hundreds of
> mothers per month who
> need help with supply issues. These issues are
> driven by poor
> breastfeeding starts, and are exacerbated by lack of
> professional
> support and assistance after the poor starts they
> receive.
>
> I have not heard of *any* bad outcomes with
> Domperidone. I have
> recommended that many women consult their doctors
> about possible use of
> this drug, in conjuntion with professional lactation
> support.
>
> Does anyone know the etiology of this FDA poison pen
> note? Was there
> one incident sparking this edict? I cannot believe
> that this is
> accidental. There must be someone or something
> behind this. I'd bet on
> that, and I am a careful gambler. Something needs
> to be done about this
> and fast. I will not recommend other drugs that are
> available in the US
> as galactogogues, because of the side effects
> present with use.
>
> Does anyone have any insight into the cause of this
> letter, and how and
> when will we organize to move this mountain off of
> the molehill?
>
> This is a serious issue for mothers. For many, it is
> the only ray of
> hope in an otherwise bleak scenario of breastfeeding
> disaster. But ah,
> someone knew that, didn't they...
>
> Kathleen Bruce RN IBCLC
>
> Kathleen Bruce RN IBCLC
> Independent consultant: Breastfeeding Clinic of
> Vermont, Lactation
> Resources of Vermont, Medela, Inc.
> Listowner Lactnet listserv
> [log in to unmask]
> Archives:
> http://peach.ease.lsoft.com/archives/lactnet.html
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