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Thread: New restrictions on domperidone recommended in EU

  1. #1

    Default New restrictions on domperidone recommended in EU

    On April 25, 2014, the European Medicines Agency completed a safety review of the drug domperidone and recommended new restrictions on its use.

    Some of the main points that may be relevant to mothers taking domperidone to increase milk supply are:

    • The safety concerns are about oral doses of domperidone, not the IV-only issues that were raised previously.

    • The side effects that prompted the review are serious cardiac reactions to the drug, including QTc prolongation, torsade de pointes, serious ventricular arrhythmia, and sudden cardiac death.

    • The risk is small, but higher when

    • the total oral dose is more than 30mg per day
    • domperidone is combined with other QT-prolonging medicines, which include many antibiotics and antidepressants
    • domperidone is combined with CYP3A4 inhibitors, including many antibiotics, antifungals, and grapefruit juice

    • The new maximum recommended oral dose is 30mg per day for no more than one week.

    • Higher doses may be safe in healthy people with no drug interactions, but more research needs to be done to determine what dosages are safe.

    Full press release from the European Medicines Agency
    Karen
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  2. #2
    Join Date
    May 2006
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    Default Re: New restrictions on domperidone recommended in EU

    Thank you for posting this, LLLKaren!!!!
    Coolest thing my big girl said recently: "How can you tell the world is moving when you are standing on it?"
    Coolest thing my little girl sang recently: "I love dat one-two pupples!"

  3. #3
    Join Date
    Mar 2014
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    Default Re: New restrictions on domperidone recommended in EU

    I'm curious, what kind of dosages do people normally take for milk production issues?

  4. #4
    Join Date
    Dec 2011
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    358

    Default Re: New restrictions on domperidone recommended in EU

    I fear these sorts of knee-jerk policy reactions will unduly restrict women's access to a viable and low-risk galactogogue. The study referenced that motivated the policy change was one that involved IV administration of domperidone in ~10x conventional oral doses to elderly cancer patients. The study groups simply aren't comparable. Give me the results of EMPOWER (a double-blind placebo controlled RCT) that show a clinically significant elevated risk and I'll change my tune.

    PO domperidone prescriptions for lactation are up to 160mg/day. I take 120mg/day.

    Here is a consensus statement on oral domperidone prescriptions as galactogogues by Dr. Newman and various members of the Canadian medical community:
    http://www.nbci.ca/docs/Domperidone_...ay_11_2012.pdf
    Last edited by @llli*alphawoman; May 7th, 2014 at 07:17 PM.

  5. #5

    Default Re: New restrictions on domperidone recommended in EU

    The IV form of domperidone was taken off the market in 1986. The studies that are referenced by the EMA are for oral doses of domperidone.

    My main reason for wanting to see this information circulated is that there is a strong tendency in lactation circles to emphasize the relative safeness of domperidone, which leads a lot of people to think it's perfectly harmless, and thus fine to purchase from an online pharmacy without a prescription.

    But of course it's not without risk, and there are situations where the risk is increased -- history of heart problems, diabetes, liver problems, etc. And it shouldn't be taken with a whole host of antibiotics, fluconazole, or a variety of antidepressants including Zoloft, which are commonly taken by nursing moms.

    So it's important that a doctor prescribes domperidone and monitors how the mom does on it. The conclusion of the Canadian consensus statement has a list of guidelines for prescribing domperidone that seem very reasonable. Hopefully the moms who are taking it are working with doctors that follow those guidelines.
    Karen
    Forums Admin

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