FDA Warns Against Use of Breast Milk Booster
Domperidone Not Approved for Use in U.S., Raising Safety Concerns
June 8, 2004 -- The FDA is warning breastfeeding women not to
use an unapproved drug called domperidone to increase breast milk
The agency says there have been several reports of severe
health risks, including irregular heartbeats, cardiac arrest, and sudden death,
associated with use of the drug that have led to its withdrawal from the market
in several countries.
Researchers say domperidone is also excreted in breast milk and
may expose infants to unknown health risks.
FDA officials say they issued the warning after they discovered
that some women who breastfeed and/or pump breast milk are purchasing
domperidone from compounding pharmacies and from foreign countries to increase
their breast milk production.
Domperidone has not been approved for use in the U.S., and
officials say use of the drug for any purpose is illegal.
Domperidone may increase the secretion of the hormone
prolactin, which is needed for lactation. However, due to the risk of serious
adverse effects, the FDA recommends that breastfeeding women not use the drug
to increase milk production.
Warnings Issued on Domperidone
In addition to advising women not to use the drug, this week
the FDA also issued six letters to pharmacies that compound drug products
containing domperidone and firms that distribute them.
The letters state that that all drug products containing
domperidone are illegal and selling or distributing them violates U.S. law.
Officials say domperidone is approved for use in several
countries outside the U.S. to treat some stomach disorders. But it is not
approved in any country for enhancing milk production.