Domperidone

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 is used, together with metoclopramide, cyclizine, and 5HT₃ receptor antagonists (such as granisetron) in the treatment of nausea and vomiting. It is useful in patients with Parkinson’s disease because, unlike metoclopramide, domperidone does not cross the blood-brain barrier.

Domperidone has also been found effective in the treatment of gastroparesis,^[2] a stomach motility condition, and for paediatric Gastroesophageal reflux (infant vomiting).

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 widely 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 still prescribed “off-label” for this use in countries besides the United States.^[4]

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]

It has been widely speculated that this action by the FDA is related to increasing drug importation from countries such as Canada.

Yet prominent doctors and pharmacists have rejected the FDA’s reasoning and still promote domperidone’s use in increasing milk supply. Such doctors and pharmacists are confident the drug is safe in the doses given for this purpose.^[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]

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.

• Domperidone Issue Brief International Academy of Compounding Pharmacists.
• GPDA letter to the FDA about Domperidone for gastroparesis

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