07 June 2004

by Anai Rhoads

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AnaiRhoads.org - The Food and Drug Administration (FDA) is warning lactating women who are using Domperidone to cease using the unapproved drug.

The drug is used to encourage lactation, by increasing the secretion of prolactin. Domperidone is also commonly used overseas for gastric disorders, however many countries have banned the drug due to serious complications.

The side effects can lead to arrhythmias, cardiac arrest, and even abrupt death in patients receiving an intravenous form of Domperidone.

The FDA sent out six letters to pharmacies and firms that supply the drug Monday, stating that all products which contain Domperidone violate the Federal Food, Drug, and Cosmetic Act because the drug is unapproved and mislabelled.

In addition to the warning letters, an Import Alert has been put out by the agency to refused imports of the drug into the United States.

The oral form of Domperidone continues to be marketed in some countries. The labels warn breastfeeding women against using the product, stating that it may harm the baby.

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