[Preamble: I admit, it sets my teeth on edge when I hear quoted  
pontificatory statements about a drug not being considered to have  
met the "standards" of the USA, when has been approved and used  
safely for years in Canada, Australia, New Zealand, the UK and Europe  
among other places. There is no pharmaceutical or scientific reason  
why metoclopramide is considered "safer" than domperidone in the USA.  
All science I've read is very much to the contrary. I can only  
conclude that the reasons for the FDA "advisory" are likely to be  
primarily political, financial, or both.]


On 07/12/2006, at 23:19, Veronica Carter wrote:

> This letter was sent to my department manager from one of our  
> perinatologists.
>
>> 18 months ago I addressed the issue of prescribing and "compounding"
>> the lactating promoting drug known as domperidone (motillium) in
>> response to MFM patients, especially those that have delivered early,
>> being directed by "lactation consultants" to ask for prescriptions  
>> for
>> this drug.  At the time, the FDA issued a warning/advisory stating
>> unequivocally that this drug should not be used by lactating mothers
>> secondary to reports of cardiac arrythmias, cardiac arrests, and  
>> sudden
>> deaths in the users of this drug.

The FDA has issued a warning, on extremely shaky pharmaceutical  
grounds; however these side effects were not reported in the users of  
this drug. They were reported in people who received high-dose  
intravenous domperidone.

>> They further advised that any pharmacy
>> caught compounding this drug would be prosecuted.

Has any such successful prosecution taken place? In May this year, it  
was ruled that compounding pharmacists are not bound by the  
prohibitions of the FDA in these matters.
http://www.asklenore.info/breastfeeding/additional_reading/ 
domperidone_ruling2006.html

More on that case here:
http://www.iacprx.org/site/PageServer?pagename=Press_Releases#052606

and Thomas Hale's statement on domperidone here:
http://www.breastfeedingtaskforla.org/domperidone.htm

Note also that domperidone is approved by the AAP as being compatible  
with breastfeeding. There are a few more references here:
http://www.kellymom.com/health/meds/prescript_galactagogue.html

Lara Hopkins

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