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Date: | Mon, 2 Apr 2001 09:05:09 -0500 |
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Last year Nancy Wight sent this post to Lactnet.
>I just spoke with the head of Medical Affairs at Janssen Pharmaceutica.
Domperidone will not be available in the USA, ever ! Due to 1 death on the
IV formulation years ago, the FDA has made them jump through too many hoops,
and they are abandoning the effort to have it approved. They will not
reconsider for an alternate indication (ie as a galactogogue).
>Nancy Wight MD, IBCLC
We all know that the one death is not the true cause of rejection of this
drug. I beleive that it is due to lobbying by the makers of Reglan. I have
read a lot about the make-up of the FDA and its drug approval approach. It
is usually *not* medically sound, but more influence based. And the make-up
of the committee has solid pharmaceutical ties. So it depends heavily on
which drug company is applying for approval.
So we are stuck. I have a few MDs who will prescribe Domperidone for my
clients, but most of them are fearful of law suits. And I have a couple of
clients who are ordering from Mexico.
By the way, one client was told that she would no longer be able to get it
from New Zealand because of some customs issue. Has anyone heard of that?
Pat Gima, IBCLC
Milwaukee, Wisconsin
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