Skip to content

    Health & Baby

    Font Size
    A
    A
    A

    FDA Warns Against Use of Breast Milk Booster

    Domperidone Not Approved for Use in U.S., Raising Safety Concerns

    WebMD Health News

    June 8, 2004 -- The FDA is warning breastfeeding women not to use an unapproved drug called domperidone to increase breast milk production.

    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.

    Baby's First Year Newsletter

    Because every week matters, get expert advice and facts on what to expect in your baby's first year.

    Today on WebMD

    mother on phone holding baby
    When you should call 911.
    parents and baby
    Unexpected ways your life will change.
     
    baby acne
    What’s normal – and what’s not.
    baby asleep on moms shoulder
    Help your baby get the sleep he needs.
     

    mother holding baby at night
    ARTICLE
    mother with sick child
    QUIZ
     
    Chinese mother breast feeding newborn baby girl
    SLIDESHOW
    Track Your Babys Vaccines
    TOOL
     
    Baby Napping 10 Dos And Donts
    Slideshow
    Mother with her baby boy
    Article
     
    baby in crib
    Slideshow
    baby gear slideshow
    Slideshow