Monday, May 9, 2011
Domperidone
Janssen Pharmaceutical has brought domperidone before the FDA several times in the last two decades, with the most recent effort in the 1990s. Numerous U.S. clinical drug trials have demonstrated its safety and efficacy in dealing with gastroparesis symptoms, but the FDA turned down Janssen's application for domperidone, even though the FDA's division of gastrointestinal drugs had approved domperidone
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The drug is available in Canada, Great Britain, the Netherlands, Japan and many other countries.
ReplyDeleteIn June 2004, the United States' main regulation agency, the FDA, issued a letter warning women not to take domperidone, citing unknown risks to parents and infants, and warned pharmacies that domestic sale was illegal, and that import shipments from other countries would be searched and seized. Domperidone is excreted in breast milk, and no studies on its effects on breastfeeding infants have been reported in the literature. Individual incidents of problems with the drug include cardiac arrest and arrhythmia, complications with other medications, as well as complications with improper intravenous use.[7] A recent paper suggests there may be increased risk of seizures to neonates of mothers taking oral domperidone.[9]
Some doctors and pharmacists do not fully accept the FDA's reasoning and still favor domperidone's use in increasing milk supply. Such doctors and pharmacists claim the drug is safe in the doses given for this purpose[10] since the morbidity in question was limited to intravaneous use.[11] The American Academy of Pediatrics considers domperidone "usually compatible with breastfeeding".[12]
There is a new controversy in Britain regarding lethal levels of sodium found in children who are administered this drug. It is now subject to a medical review following a number of criminal trials where parents were charged with child abuse by salt poisoning based on hypernatremia in the affected children.[13] Recent studies also cite increased QT intervals in neonates taking Domperidone.[14]
this is from Wikipedia outlining the controversy.
Hmmm . . . not thinking your hubby's going to breastfeed any babies anytime soon! From what you have written, it seems that the benefits would outweigh the risks for him.
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