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Subject:
From:
christia bridges-jones <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Mon, 27 Jul 2009 20:49:46 -0700
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July 16, 2009 — The US Food and Drug Administration (FDA) has approved
safety labeling revisions to advise of the risk for
metoclopramide-induced tardive dyskinesia; and the potential for
adverse cardiovascular events, probable dementia, and breast cancer in
patients receiving long-term estrogen-progestin therapy.

Metoclopramide (Reglan) Linked to Risk for Tardive Dyskinesia

On June 30, the FDA approved safety labeling revisions for
metoclopramide tablets, orally disintegrating tablets, and injection
(Reglan; Alaven Pharmaceuticals, LLC) to include a boxed warning
regarding the risk for tardive dyskinesia (TD).

TD is a potentially irreversible and disfiguring disorder
characterized by involuntary movements of the face, tongue, or
extremities.

The risk for the development of metoclopramide-induced TD and the
likelihood that TD will become irreversible increase with duration of
treatment and total cumulative dose; other factors may include older
age, female sex, and the presence of diabetes mellitus.

In 1 published study, TD was reported at a prevalence of 20% among
patients receiving metoclopramide for at least 12 weeks.
Metoclopramide therapy should therefore be limited to a 3-month period
unless its therapeutic benefit is thought to outweigh the risk for the
development of TD.

Metoclopramide should be discontinued in patients in whom signs or
symptoms of TD develop. Although there is no known treatment of the
disorder, symptoms may lessen or resolve within several weeks to
months after metoclopramide therapy is stopped.

The FDA notes that use of metoclopramide can also suppress signs of
TD, thereby masking the underlying disease process. Metoclopramide
should not be used for the symptomatic suppression of TD because its
long-term effects are unknown.

Metoclopramide is indicated for the short-term (4 - 12 weeks)
treatment of gastroesophageal reflux disease in patients in whom
failure to respond to conventional therapy occurs and for the
treatment of symptoms of diabetic gastroparesis.
==============
Christia Bridges-Jones, IBCLC
Chandler, AZ

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