[e-drug] Pantoprazole and Domperidone (2)

["Sarah Sellers" <sarahsellers@mac.com>]

E-DRUG: Pantoprazole and Domperidone (2)
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Dear Ajay-

 I have been interested in safety issues concerning domperidone where it has
been promoted and dispensed by compounding pharmacies in the U.S. to
stimulate or increase lactation in breast-feeding women--this is of concern
particularly because the the drug has been associated with QT prolongation
with IV use and recommended doses for lactation are significantly higher
than doses recommended in over-the-counter remedies available in Europe. 

The drug is not approved for marketing in the US for any indication but FDA does
have an Emergency IND (Investigational New Drug) program for physicians to
prescribe the drug for severe gastroparesis or severe GI motility disorders
that are refractory to standard therapy.

 Most recently, clinicians in Brazil reported: QT interval prolongation
associated with oral use of domperidone in an infant which normalized after
the drug was withdrawn.  The authors recommend serial  ECGs with oral use to
"detect abnormalities of the corrected QT interval and thus avoid any
proarhythmic events". 

 See:  

Rocha CMG and Barbosa MM. QT Interval Prolongation Associated with the Oral
Use of Domperidone in an Infant. Pediatr Cardiol. 2005 Feb 10-[epub ahead of
print]

US Food and Drug Administration: How to obtain Domperidone
http://www.fda.gov/cder/news/domperidone.htm

 Best,

 Sarah

Sarah Sellers, PharmD MPH
sarahsellers@mac.com