The FDA has made it clear that it considers domperidone unsafe, especially for breastfeeding mothers. But what about pediatric groups, mothers, and breastfeeding activists? Why is it important to them that this drug gets FDA approval when there are other drugs out there intended for aiding lactation? Why do they feel that they are being targeted unfairly by the FDA?
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.
Prescription domperidone, also known as brand name Motilium, has been widely available in almost every country around the world except the US since 1978. Motilium was approved over 20 years ago in Canada, and is the gastrointestinal medication of choice to treat nausea and vomiting in most countries. More recently, Motilium, or generic domperidone, has been increasingly prescribed to stimulate lactation in breast-feeding women with a poor milk supply.
Motilium has been widely available in almost every country around the world except the US since 1978. Motilium was approved over 20 years ago in Canada, and is the gastrointestinal medication of choice to treat nausea and vomiting in most countries. More recently, Motilium has also been increasingly prescribed to stimulate lactation in breast-feeding women.
The British Columbia Drug and Poison Information Centre (DPIC) has posted an article titled Domperidone - Keeping Abreast of the Controversies on their website. The article, written by Karen Wlock, B.Sc. (Pharm), is in response to frequent questions received by the Canadian organization about the use of prescription domperidone for breastfeeding.
On June 7, 2004, the Food and Drug Administration (FDA) warned compounding pharmacies and firms that supply domperidone for use in compounding that it is illegal to compound domperidone and issued an import alert advising FDA field personnel that they may detain shipments of finished drug products and bulk ingredients containing domperidone. These actions were the result of the Agency's concern about the potential public health risks associated with the use of domperidone by lactating women. Although FDA has determined that domperidone should not be compounded or used to enhance breast milk production in lactating women, there are some patients with severe gastrointestinal disorders, such as severe gastroparesis or severe GI motility disorders that are refractory to standard therapy, who may benefit from the drug and in whom the drug's benefits outweigh its risks.