FDA cautions breast-feeding moms

FDA Consumer, Sept-Oct, 2004

Women who are breast-feeding should not use the unapproved drug domperidone to increase milk production due to safety concerns, the FDA says. The drug is excreted in breast milk and could expose a breast-feeding infant to unknown risks.

Published reports and case studies have cited cardiac arrhythmias, cardiac arrest, and sudden death in people receiving an intravenous form of domperidone, which has been withdrawn from the market in several countries. In areas where the oral form of domperidone continues to be available, labels for the product contain specific warnings against its use by breast-feeding women.

Recognizing the immense health benefits that breast milk provides for a nursing infant, the FDA has issued the warning, not to discourage women from breast-feeding, but rather to inform them of the potential harm from using this particular drug while breast-feeding. In fact, the U.S. Department of Health and Human Services' Office on Women's Health and the Advertising Council announced in June 2004 the launch of a new national campaign that encourages first-time mothers to breast-feed exclusively for six months.

The FDA has issued six warning letters to pharmacies that compound products containing domperidone and firms that supply the drug for use in compounding. Compounding, as it relates to pharmacies, includes the preparation, mixing, assembling, packaging, or labeling of a drug in response to a prescription written by a licensed health care practitioner. The letters state that all drug products containing domperidone, whether compounded or not, violate the Federal Food, Drug, and Cosmetic Act because they are unapproved new drugs and misbranded. Further violations may result in enforcement actions, including seizure, according to the FDA letters.

In addition, the agency has alerted field personnel to watch for any attempts to import domperidone so that it can be detained and refused entry into the United States. Importation of domperidone-containing products also is a violation of the law.