One can only speculate why the company has not asked for approval of this
medication.  It is a very expensive proposition to get a drug approved by
the FDA.  At the time domperidone came out, there was already a gastric
motility agent of a similar type already on the market
(metoclopramide--Reglan), and perhaps the company did not feel the potential
sales were worth the trouble.  Then cisapride came on the market and then
there was even less motivation for the company, especially since cisapride
was supposed to be safer than metoclopramide (wrong!!).

I have heard somehow, that there was one death that occurred when
domperidone was given IV, though I did not know it was available IV.  And
that this would have made the drug harder to get through the FDA.  However,
not to put too fine a point on it, there isn't a drug out there that hasn't
killed somebody.

From my experience, though, I would say that domperidone is a lot safer than
aspirin, say.

Jack Newman, MD, FRCPC

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