updated 6/8/2004 2:41:05 PM ET 2004-06-08T18:41:05

The government is warning breast-feeding women not to use a drug called domperidone to increase their milk production, saying it not only is illegal but could harm both mother and child.

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The Food and Drug Administration cracked down on the drug Monday, moving to end imports and ordering several companies to quit making or distributing it here.

The concern: There are reports of serious side effects among adult users, and domperidone is excreted in breast milk.

Domperidone has never been approved for sale in the United States, but is used in some countries to treat certain stomach disorders.

A side effect is stimulation of a breast milk-producing hormone — but no country has approved the drug’s use for lactation, and several require explicit warnings against use by breast-feeding mothers.

Yet FDA fears domperidone use may be increasing among breast-feeding Americans. Women have long been able to order it from abroad via the Internet, but FDA recently discovered a few U.S. pharmacies providing “compounded” supplies — drugs that pharmacists brew up specially for certain customers.

Serious side effects reported
Monday, the FDA ordered an end to compounded domperidone and the detention of imports.

FDA counts over 2,000 reports of side effects from 33 countries related to domperidone. An intravenous form was banned worldwide after it was linked to cardiac arrest, sudden death, and irregular heartbeat. Seizures and other neurologic side effects have been reported with high oral doses, FDA warned.

Abroad, the maximum oral dose for stomach disorders is 80 milligrams a day. But FDA officials cite reports of women taking twice that much to increase breast milk production. While FDA says little is known about effects on infants, presumably the mother’s dose determines how much is excreted into breast milk.

In addition, using certain other medicines, such as the antibiotic erythromycin, raises blood levels of domperidone even further, FDA warned.

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