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FDA warning for using dromperidone for lactation

On June 7, 2004 the FDA issued warnings to six pharmacies that compound domperidone and firms that supply domperidone for compounding. The letters stated that products containing domperidone violate the Federal Food, Drug, and Cosmetic Act. The FDA is also warning their field personnel to be on the lookout for attempts to import domperidone and take proper action if necessary.

Breastfeeding women may be using domperidone to increase milk production (lactation). This is an unapproved drug that is not to be used because of safety concerns. It is found that domperidone may increase the secretion of prolactin, a hormone needed for lactation. However, it is not approved for this use in the US or in any country. It is approved in some countries outside the US to treat certain gastric disorders.

The FDA is worried about the potential health risks involved with domperidone. Several case studies and reports have shown the risk of cardiac arrhythmias, cardiac arrest, and sudden death in patients receiving an IV form of domperidone, which has been withdrawn from market in many countries. In countries where the oral form is marketed, the labeling warns breastfeeding women that the drug is excreted in breast milk and that the risks are unknown. The FDA will take action to discourage use of domperidone in women who are breastfeeding.

Reference: www.fda.gov

Pam Spohn

PharmD, student