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FDA Won't Approve Domperidone

July 6, 2011 by EStella     0

With an increase in purchases of domperidone from foreign countries and compounding pharmacies, the FDA has issued a warning against domperidone, specifically aimed at breastfeeding women. While many argue that the measures they are taking are too extreme, the FDA stands by its decision. The reasons they give centre mainly on the safety concerns related to domperidone, and the lack of studies to back up the appropriateness of its use for stimulation of lactation.

Not Approved for Any Indication in USA

Domperidone is not approved by the FDA for any indication. It is approved in Canada and other countries for treatment of gastrointestinal issues such as gastroparesis, but is not approved in any country for stimulation of lactation. The manufacturer of domperidone does not promote the drug for use for lactation either.

Risk of Cardiac Arrest

The FDA is particularly concerned by reports and studies that have shown an increase in risk of cardiac arrhythmia, cardiac arrest, and sudden death in patients receiving domperidone intravenously. Intravenous forms of the drug have been pulled from the market. While breastfeeding women are generally prescribed the oral form, and in lower doses than seen in the cases referenced, many countries specifically advise against use of domperidone by breastfeeding women.

Risk to Infants

There are concerns, as with any drug given to breastfeeding mothers, about transfer to the infant through breast milk. While the American Association of Pediatrics lists domperidone as a safe drug for breastfeeding mothers, with no effect on the infant, reports have shown elevated sodium levels and risk of seizure in infants and children who are exposed to domperidone.

The FDA is taking actions to make sure that domperidone is not being sold or distributed in the US, and is ensuring that any order containing the drug is stopped at the border. The FDA is adamant that these measures are not being taken to discourage breastfeeding, and it recognizes that breastfeeding provides excellent health benefits to both mother and child. Its main concern, however, is to ensure the safety of the population, and its current stance is that the health risks associated with domperidone outweigh the benefits of breastfeeding.

Filed under: FDA and Domperidone.

Tags: domperidone, motilium, domperidone and fda, domperidone lactaton, domperidone for breastfeeding, domperidone gastroparesis, domperidone in usa .

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