Not approved for use or sale: US; prescription medicine: Australia, Canada; Over the Counter (OTC): UK, Belgium, Ireland, Italy, Japan, Netherlands, South Africa, Switzerland, China, Russia, Slovakia, Malta, South Korea, and Romania[1]
Domperidone (trade name Motilium or Motillium) is an antidopaminergic drug, developed by Janssen Pharmaceutica, and used orally, rectally or intravenously, generally to suppress nausea and vomiting. It has also been used to stimulate lactation.
Domperidone has also been found effective in the treatment of gastroparesis,[2] a stomach motility condition, and for paediatric Gastroesophageal reflux (infant vomiting).
Lactation
The hormone prolactin stimulates lactation in humans, and its release is inhibited by the dopamine secreted by the hypothalamus. Domperidone, by acting as an anti-dopaminergic, results in increased prolactin secretion, and thus promotes lactation.
Although it has never been officially approved for use in the United States, domperidone is sometimes purchased from pharmacies in other countries for this purpose. Since, according to the FDA, domperidone is not approved for enhanced lactation in any country,[3] it is sometimes self-prescribed from original research or prescribed "off-label" for this use in countries besides the United States.[4]
Controversy
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.[5]
In June 2004, the United States' main regulation agency, the Food and Drug Administration (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[4]
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 but have no evidential data or studies to base their claim.[6] The American Academy of Pediatrics considers domperidone "usually compatible with breastfeeding".[7]
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.[8]
Brand
Domperidone is marketed in India by Ion healthcare under the brand name MELDOM-DT.
Also conjuction with Pantoprazole as Dompan Tablets mktg by MEDLEY Pharma. Ltd.
v•d•e
Drugs for functional gastrointestinal disorders (A03)
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